ETHIOPIAN FOOD AND DRUG AUTHORITY DOCUMENT No.: EFDA/GDL/090 VERSION No: 001 DATE OF APPROVAL: 15.06.2026 DATE OF FIRST ISSUE: 2026 Document History Version No. Reason for Amendment Effective Date 001 It Is new guideline 30.06.2026 Bezawork Birhane Medical device Manufacturers Inspection and Enforcement Lead Executive office June, 2026 Addis Ababa, Ethiopia Table of Contents Contents Table of Contents .......................................................................................................................................................... 2 Acronyms and Abbreviations ....................................................................................................................................... 4 CHAPTER ONE: INTRODUCTION ........................................................................................................................... 5 1.1 Background ......................................................................................................................................................... 5 1.2 Legal Basis .......................................................................................................................................................... 5 1.3 Objectives ...................................................................................................................................................... 6 1.4 Scope ................................................................................................................................................................... 6 1.5 Relationship to Other EFDA Guidelines............................................................................................................. 6 CHAPTER TWO: DEFINITIONS AND IMDRF TERMINOLOGY .......................................................................... 7 2.1 Definitions........................................................................................................................................................... 7 2.2 IMDRF Terminology for Categorized Adverse Event Reporting ....................................................................... 9 CHAPTER THREE: RESPONSIBILITIES OF THE MANUFACTURERS AND GUIDANCE ON REPORTING .................................................................................................................................. 13 3.1. Adverse event/Incident reporting system ..................................................................................................... 15 3.2. Reporting Guidance ..................................................................................................................................... 16 3.2.1. What to be reported ....................................................................................................................... 16 3.2.2. When to report ............................................................................................................................... 18 3.2.3. How to report ................................................................................................................................. 19 3.2.4. Where to report ............................................................................................................................. 19 3.3. Reporting of use error .................................................................................................................................. 19 3.3.1. Reportable use errors ..................................................................................................................... 20 3.4. Periodic safety summary reporting: ............................................................................................................. 20 3.4.1. Incidents Described in a Field Safety Notice ................................................................................. 20 3.4.2. Common and well-documented incidents ...................................................................................... 21 3.5. Trend reports ................................................................................................................................................ 21 3.5.1. Adverse Event Trending. ............................................................................................................... 21 3.5.2. Trending procedure and significant increase:................................................................................. 21 3.5.3. Complaint trending and adverse event trending: ............................................................................ 22 3.6. Investigations ............................................................................................................................................... 22 3.6.1. Principles ....................................................................................................................................... 22 3.6.2. Access to the Device Suspected to be involved in the Incident...................................................... 22 3.7. Outcome of an Investigation and Follow-up ................................................................................................ 23 3.7.1. Principles ....................................................................................................................................... 23 3.7.2. Follow-up Report........................................................................................................................... 23 3.7.3. Final Report ................................................................................................................................... 23 3.8. Field Safety Corrective Action (FSCA) and Field Safety Notice (FSN)....................................................... 23 CHAPTER FOUR: RESPONSIBILITIES OF USERS AND ...................................................................................... 25 GUIDANCE ON REPORTING .................................................................................................................................. 25 4.1. Reporting Guidance ..................................................................................................................................... 25 4.1.1. What to report ................................................................................................................................ 25 4.1.2. When to report ............................................................................................................................... 26 4.1.3. How to report ................................................................................................................................. 26 4.1.4. Where to report .............................................................................................................................. 26 4.1.5. What to do with the device. ........................................................................................................... 26 4.2. Field Safety Corrective Action Guidance..................................................................................................... 27 4.2.1. Importance of Field Safety Notices (FSNs) ................................................................................... 27 4.2.2. Distribution .................................................................................................................................... 27 4.2.3. Action ............................................................................................................................................ 27 4.2.4. Access to devices ........................................................................................................................... 27 CHAPTER FIVE: RESPONSIBILITY OF EFDA ..................................................................................................... 28 5.1. Receive Adverse Event/ incident report from manufacturer, users or other systems .................................. 28 5.2. Risk evaluation. ............................................................................................................................................ 28 5.2.1. The risk assessment of an incident or FSCA reported may include where relevant: ....................... 28 5.2.2. Monitoring of manufacturers subsequent actions ........................................................................... 28 5.2.3. Monitoring of experience with the use of devices of the same kind ....................................... 29 5.3. Actions and Recommandations .................................................................................................................... 29 5.4. Dissemination of information ...................................................................................................................... 30 5.5. Completion of the investigation ................................................................................................................... 31 Annexes....................................................................................................................................................................... 33 Annex I: Examples of incidents and field safety corrective actions which the manufacturer should report. .......................................................................................................................................................... 33 ANNEX II: Manufacturer Initial Report Form ........................................................................................................... 36 ANNEX III: Manufacturer Follow-Up Report Form.................................................................................................. 38 ANNEX IV: Manufacturer Final Report Form ........................................................................................................... 39 ANNEX V: Reporting Form for Healthcare Facilities, Health Professionals, Patients, Users, and Caregivers ............................................................................................................................................................ 40 ANNEX VI: Trend Report Form ................................................................................................................................ 41 ANNEX VII: Periodic Safety Summary Report Form ............................................................................................... 42 Acronyms and Abbreviations Acronym Meaning AE Adverse Event AR Authorized Representative EFDA Ethiopian Food and Drug Authority FSCA Field Safety Corrective Action FSN Field Safety Notice GMDN Global Medical Device Nomenclature IFU Instructions For Use IMDRF International Medical Device Regulators Forum IVD In Vitro Diagnostic Medical Device MAH Marketing Authorization Holder MDMIE LEO Medical Device Manufacturers Inspection and Enforcement Lead Executive Office MDV&PMS Medical Device Vigilance and Post-Market Surveillance PSSR Periodic Safety Summary Report UDI Unique Device Identification WHO World Health Organization
CHAPTER ONE: INTRODUCTION
CHAPTER ONE: INTRODUCTION
1.1
The Ethiopian Food and Drug Authority (EFDA), established and mandated by the Food and Medicine Administration Proclamation No. 1112/2019, is responsible for ensuring the quality, safety, and performance of medical devices placed on, and made available on, the Ethiopian market. Within EFDA, the Medical Device Manufacturers Inspection and Enforcement Lead Executive Office (MDMIE LEO) discharges this mandate through its Medical Device Vigilance and Post-Market Surveillance (MDV&PMS) Desk. Medical devices play a crucial role in healthcare delivery, supporting treatment, diagnosis, screening, monitoring, prevention, and mitigation of disease. Because pre-market review cannot predict every device failure or every consequence of intended and unintended use, systematic collection, reporting, and investigation of adverse events and incidents after a device reaches the market is essential to protect patients, users, and the public, and to generate the evidence base needed for timely corrective action. This Guideline sets out EFDA's requirements for medical device vigilance: the detection, reporting, and investigation of adverse events and incidents. It adopts the internationally harmonized terminology developed by the International Medical Device Regulators Forum (IMDRF) for categorized adverse event reporting, so that vigilance data generated in Ethiopia is comparable with, and can be exchanged with, other national regulatory authorities and international bodies. Where appropriate, EFDA participates in regional and global vigilance networks, including those coordinated by IMDRF and WHO, to exchange safety signals, align terminology, and benefit from the experience of other National Regulatory Authorities. It may also recognize or give due consideration to vigilance decisions, safety communications, and investigation outcomes issued by other National Regulatory Authorities or by WHO-listed authorities concerning the same device.
1.2
This Guideline is issued under Article 4(9) and Article 38 of the Food and Medicine Administration Proclamation No. 1112/2019, which mandate EFDA to monitor the safety and performance of medical devices throughout their lifecycle and to require reporting of adverse events by manufacturers, authorized representatives, healthcare facilities, users, health professionals, and other stakeholders. It is further informed by: ● The WHO Global Model Regulatory Framework for medical devices, including in vitro diagnostic medical devices (2023); ● IMDRF Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology, structure and codes, Edition 4, including its updated annexes (Release 2024); and ● WHO Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics (2020),
1.3
To define, precisely and technically, who must report, what must be reported, within what timelines, and through what channels. To establish a structured, IMDRF-aligned methodology for investigating reportable events and determining causality, so that conclusions are consistent, defensible, and internationally comparable. To enable the Authority to detect emerging safety concerns from individual reports, trend reports, and periodic vigilance summaries. To provide manufacturers, healthcare facilities, health professionals, and users with clear, fillable reporting instruments that reduce the burden of reporting and improve data quality.
1.4
This Guideline applies to all medical devices placed or made available on the Ethiopian market, and to the detection, reporting, investigation, response and sharing of adverse events and incidents associated with those devices.
1.5
EFDA maintains dedicated, standalone guidelines for Field Safety Corrective Action (FSCA) and Field Safety Notices, for product recall, and for post-market surveillance (PMS) of medical devices. This Guideline covers only the detection, reporting, investigation, and follow-up of adverse events and incidents (vigilance) and refers the reader to those separate guidelines for the detailed procedural requirements governing FSCA, recall, and routine PMS activities, including periodic PMS reporting that is not itself event-triggered. Where this Guideline and any of those separate guidelines overlap (for example, an incident that also triggers an FSCA), the reporter should comply with both guidelines concurrently; this Guideline does not override or duplicate the specific obligations set out in the FSCA, Recall, or PMS guidelines.
CHAPTER TWO: DEFINITIONS AND IMDRF TERMINOLOGY
CHAPTER TWO: DEFINITIONS AND IMDRF TERMINOLOGY
2.1
Adverse Event: Any unintended and undesirable result of a medical device, including device malfunction, failure, or deterioration in characteristics or performance, and any inadequacy in labelling or instructions for use, that led, or might have led, to death, serious injury, or serious deterioration in the state of health of a patient, user, or other person, or to a serious threat to public health. Adverse Event Following Implantation: An adverse event that occurs after a medical device has been implanted into the body, including device malfunction, failure, migration, or infection attributable to the device. Abnormal Use: An act or omission by an operator or user of a medical device that is beyond any reasonable means of manufacturer risk control, and that is not the result of a foreseeable use error. Cause Investigation: The technical process of examining a returned device, associated records, and surrounding circumstances to determine the type of investigation performed and its findings and conclusion, categorized where possible using IMDRF Annexes B, C and D. Corrective Action: Action to eliminate the cause of a detected nonconformity or other undesirable situation, in order to prevent recurrence. Device Problem: The manner in which a medical device is observed or suspected to have failed, malfunctioned, or otherwise not performed as intended, categorized using IMDRF Annex A. Final Report: The report submitted on completion of a manufacturer's investigation of a reportable event, documenting root cause, corrective action taken or planned, and conclusion, including all applicable IMDRF codes. Follow-Up Report: A report submitted to update EFDA on the status or findings of an ongoing investigation of a previously reported event, before the Final Report is available. Health Effect: The clinical sign, symptom, condition, or broader health impact experienced by a patient, user, or other person as a result of an adverse event, categorized using IMDRF Annexes E and F. Incident: Any malfunction or deterioration in the characteristics or performance of a device, or any inadequacy in its labelling or instructions for use, which directly or indirectly might lead to, or might have led to, death, serious injury, or a serious threat to public health. Initial Report: The first report of a reportable event submitted to EFDA by a manufacturer, authorized representative, or other reporter, containing the information available at the time of first becoming aware of the event. Investigation Conclusion: The final determination reached by a manufacturer following investigation of a reportable event, categorized using IMDRF Annex D, describing whether and how the device contributed to the event. Near Miss: An event or situation that did not produce patient, user, or bystander harm, but had the potential to do so had circumstances been different, and which is recorded to support proactive risk identification. Periodic Safety update Report: A report submitted by a manufacturer at a defined interval, summarizing all adverse events and incidents associated with a device or device family reported during that period, independent of whether an individual reportable threshold was met for each entry. Preventive Action: Action to eliminate the cause of a potential nonconformity or other undesirable situation, in order to prevent its occurrence. Product Quality Defect: An attribute of a medical device or its component that may affect its quality, safety, and/or performance, or that is inconsistent with the approved marketing authorization, including suspected contamination, substandard components, or defective packaging or labelling. Reportable Event: An adverse event or incident that meets the reporting criteria set out in this Guideline and therefore requires notification to the Authority within the applicable timeline. Signal: Information arising from one or more reportable events which suggests a new, or a new aspect of a known, association between a medical device and an adverse outcome, of sufficient likelihood to justify verification and, where confirmed, a determination on further regulatory referral. Trend Report: Information supplied following an increase in the reported frequency or severity of an incident type not usually subject to individual reporting, of a type or magnitude that meets a manufacturer's or EFDA's pre-defined trend-reporting threshold. Use Error: An act or omission of an act by a user that produces a result different from that intended by the manufacturer or expected by the user, potentially attributable to device design, labelling, or user interface deficiencies.
2.2
To ensure that vigilance data generated under this Guideline is technically precise and internationally comparable, EFDA requires the use of the IMDRF Terminologies for Categorized Adverse Event Reporting (AER) wherever an applicable code exists. The IMDRF terminology comprises seven annexes (A–G), grouped into three functional areas: the device problem observed (Annex A); the cause investigation performed, its findings, and its conclusion (Annexes B, C and D); and the health effect on the affected person, described both clinically and by overall impact (Annexes E and F). Annex G identifies the specific device component involved. Each report shall carry at least one code from each applicable annex; more than one code may be assigned within an annex where more than one problem, finding, or effect applies. The tables below reproduce the current structure and representative terms of each IMDRF annex for ready reference. The complete and authoritative code sets are maintained by IMDRF and updated periodically; Manufacturers and authorized representatives, should use the current IMDRF release for full code lists, whereas healthcare facilities, users, health professionals, and other stakeholders are advised to utilize the codes in their reporting if convenient. Annex A — Medical Device Problem Describes the manner in which the device is observed or suspected to Purpose have failed or malfunctioned. Required at Required at Initial Report Device operates differently than expected; No apparent device problem; Material/component deficiency; Alarm/signal problem; Failure to alarm Representative or alert; Electrical or electronic problem; Software problem/application terms deficiency; Break, cut, tear, puncture, crack, or other physical damage; Contamination of device or product; Infusion or flow problem Annex B — Cause Investigation — Type of Investigation Purpose Describes the type of investigation carried out on the device following the event. Required at Required at Final Report Device evaluation performed by manufacturer; Device evaluation not Representative performed (device not returned); Device evaluation not performed terms (device not evaluable); Third party laboratory evaluation; Root cause analysis; Software/firmware code review Annex C — Cause Investigation — Investigation Findings Purpose Describes the technical findings of the investigation performed under Annex B. Required at Required at Final Report No abnormalities/no failure found; Component/material failure Representative confirmed; Software anomaly confirmed; Manufacturing deviation terms confirmed; Design deficiency confirmed; Evidence of use error; Evidence of abnormal use; Evidence of maintenance/service deficiency Annex D — Investigation Conclusion Describes the final determination of whether, and how, the device Purpose contributed to the reported event. Required at Required at Final Report Device caused or contributed to the event; Device did not cause or contribute to the event; Insufficient information to determine device Representative involvement; Investigation ongoing / conclusion pending; Event terms attributable to underlying disease/condition; Event attributable to use error, not device deficiency Annex E — Health Effect — Clinical Signs, Symptoms or Conditions Purpose Describes the clinical sign, symptom, or condition experienced by the affected person. Required at Required at Initial Report Death; Hemorrhage; Infection; Allergic/immunological reaction; Burn; Representative Pain; terms Neurological signs and symptoms; Cardiac/vascular signs and symptoms; No clinical signs, symptoms, or conditions Annex F — Health Effect — Health Impact Purpose Describes the overall severity/impact of the health effect on the affected person. Required at Required at Initial Report Death; Life-threatening injury/illness; Hospitalization (initial or Representative prolonged); Disability or permanent impairment; Congenital terms anomaly/birth defect; Required intervention to prevent permanent impairment; No health impact Annex G — Medical Device Component Identifies the specific device component or part involved in or affected Purpose by the incident. Required at Required at Final Report, where applicable Representative Battery/power supply; Software/firmware; Alarm system; terms Connector/coupling; Sensor; Housing/casing; Packaging; Accessory (specify)
CHAPTER THREE: RESPONSIBILITIES OF THE MANUFACTURERS AND GUIDANCE ON REPORTING
MANUFACTURERS AND GUIDANCE ON REPORTING The medical device manufacturer or his authorized representative is responsible for: Having suitable vigilance systems in place for proactive scrutiny of trends in complaints and incidents occurring with their devices. Designating, in writing, a named individual responsible for vigilance (a Vigilance Responsible Person) within their organization or their Authorized Representative in Ethiopia, with the authority and competence to receive, evaluate, and ensure timely reporting of adverse events, incidents, and trends to EFDA, and communicating this designation to EFDA upon request. Notifying EFDA about AE/incidents when the reporting criteria are met. Investigating and assessing the incidents. The manufacturer normally performs the investigation, while EFDA monitors progress. Timeframe for follow up and/or final reports should be defined. Submitting a trend report when the trend reporting criteria are met; in addition, the Authority may request the manufacturer to demonstrate that the trending method applied is appropriate for the case. Submitting a periodic safety summary report to the Authority. Notifying the Authority about the field safety corrective actions of their products (submit a field safety notification). Undertaking any corrective action necessary. Issue a field safety notice in relation to the field safety corrective action approved by the authority. Distribute the field safety notice to the appropriate organizations/ users. The manufacturer should ensure that the following parties are kept informed about these guidelines, incident reports as appropriate, so that the manufacturers’ responsibilities may be fulfilled in Ethiopia: o authorized representatives in Ethiopia, o persons responsible for placing devices on the market and o Any other agents authorized to act on their behalf for purposes related to medical devices regulation or vigilance. The manufacturer should encourage and promote the involvement of the users in the incident reporting and implementation of FSCA. Implantable Devices manufacturers must actively monitor and address potential risks associated with their devices, including adverse events and device failures. They must ensure that traceability systems are in place to support safe and effective use. Ionizing Radiation Source Devices Manufacturers must prioritize radiation safety, to ensure the safe and effective use of these devices. They should provide training and education to healthcare providers on proper handling and use of their devices. Note: Where an incident occurs as a consequence of the combined use of two or more separate devices (and/or accessories) made by different manufacturers, each manufacturer should submit a report to the Authority. Manufacturers of diagnostic and monitoring devices: Vigilance reporting for IVDs and other diagnostic devices may be more difficult since IVDs do not generally come into contact with patients. Therefore, it can be difficult to demonstrate direct harm to patients, unless the device itself causes deterioration in state of health. Harm to patients is more likely to be indirect - a result of action taken or not taken on the basis of an incorrect result obtained with an IVDs. Whether as a result of direct or indirect harm, incidents should be reported. It may be difficult to determine if a serious deterioration in the state of a patient’s health was or could be the consequence of an erroneous result obtained with an IVD, or if the harm was the consequence of an error by the user or third party. There should be a predisposition to report under such circumstances. In the case of potential errors by users or third parties, labeling and instructions for use should be carefully reviewed for any possible inadequacy. This is particularly true for devices used for self-testing where a medical decision may be made by the patient. Inadequacies in the information supplied by the manufacturer that led or could have led to harm to users, patients or third parties should be reported. In particular, it can be extremely difficult to judge events in which no harm was caused, but where harm could result if the event was to occur again elsewhere.
3.1
3.1.1. General principles The manufacturer or their authorized representative shall submit an initial incident report to the Authority for recording and evaluation of incidents. Each initial report must lead to a final report unless the initial and the final report are combined into one report. But not every incident report will lead to a corrective action. As a general principle, there should be a predisposition to report rather than not to report in case of doubt on the reportability of an incident. Reference to the following considerations the incidents will be reported or should be kept on file by the manufacturer in the case of a decision not to report. o Incidents which occurred outside Ethiopia and do not lead to a field safety corrective action relevant to Ethiopia do not need to be reported. o Incidents which occurred outside Ethiopia and lead to a field safety corrective action relevant to Ethiopia must be reported as a field safety corrective action. ● If the manufacturer is located outside Ethiopia, a suitable local contact point should be provided. This may be the manufacturer's authorized representative, persons responsible for placing devices on the market or another agent authorized to act on their behalf for purposes relating to medical devices vigilance. ● Where an incident occurs as a consequence of the combined use of two or more separate devices (and/or accessories) made by different manufacturers, each manufacturer should submit a report to the authority. ● If the initial report is made verbally (e.g. through free toll 8482), it should always be followed as soon as possible by a written report by the manufacturer or the authorized representative. ● If the manufacturer receives a user report forwarded from EFDA, the manufacturer’s responsible person shall check this report against the three reporting criteria listed under Reporting guidance for Manufacturers and submit an initial incident (or follow-up/final) report to the authority, if the event fulfills the relevant reporting criteria or o If the manufacturer considers the event not to fulfill the reporting criteria, provide a justification why this is not reportable to the authority with details of what use will be made of the information. (E.g. added to complaints file)
3.2
Reporting Guidance
3.2.1
If the manufacturer's device caused or suspected to cause an event which meets three basic reporting criteria listed below (I-III); it is considered as a reportable adverse event/incident and must be reported to EFDA by the manufacturer. I. An event has occurred An adverse event/incident related to a medical device that has led or may lead to mild or moderate or serious threat to public health or death or serious injury if one or more of the following events occur but not limited to; a. A malfunction or deterioration in the characteristics or performance including defective components; a failure of a device to perform in accordance with its intended purpose when used in accordance with the manufacturer’s instructions. b. An incorrect or out of specification test result; c. The discovery of a design defect during design review and poor construction of device; d. An inaccuracy in the labeling, instructions for use and/or promotional materials; Inaccuracies include omissions and deficiencies. Omissions do not include the absence of information that should generally be known by the intended users. e. The discovery of a serious public health threat; f. Inappropriate therapy; g. Unanticipated adverse reaction or unanticipated side effect; h. Use Error i. Delayed diagnosis and treatment j. Degradation/destruction of the device (e.g. fire); k. Interactions with other substances or products; l. False positive or false negative test result falling outside the declared performance of the test; m. Transfusion of inappropriate materials n. Other information is becoming available. II. The device is suspected to be a contributory cause of the incident In assessing the link between the device and the event, the manufacturer should take into account: a. The opinion, based on available information, from a healthcare professional. b. The results of the manufacturer’s own preliminary assessment of the incident c. Information concerning previous, similar events. d. Complaint trends. e. Other information held by the manufacturer. This judgment may be difficult when there are multiple devices and drugs involved. In complex situations, it should be assumed that the device may have caused or contributed to the incident and the manufacturers should tend to err on the side of caution. III. Serious event which led, or might have led, to one of the following outcomes a. Death of a patient, user or other persons; b. A serious injury or serious deterioration to a patient, user or other person, including ⮚ A life-threatening illness or injury, ⮚ Permanent impairment of a body function or permanent damage to a body structure ⮚ A condition necessitating medical or surgical intervention to prevent life-threatening illness or permanent impairment Examples: - clinically relevant increase in the duration of a surgical procedure ⮚ a condition that requires hospitalization or significant prolongation of existing hospitalization ⮚ any indirect harm as a consequence of an incorrect diagnostic or IVD test results when used within manufacturer's instructions for use, and ⮚ fetal distress, fetal death or any congenital abnormality or birth defects c. A near miss adverse event This is an event that might have led to a death or serious injury. It may be that due to the timely intervention of a healthcare practitioner a death or serious injury did not occur. For an event to be defined as a near adverse event, it is sufficient that: An event associated with the device happened if the event occurred again, it might lead to death or serious injury testing or examination of the device or the information supplied with the device, or scientific literature indicated some factor that could lead to a death or serious injury. (See annex 1 for examples of the reportable incidents)
3.2.2
Upon becoming aware that an event has occurred and that one of its devices may be associated with the adverse event /incident the devices Manufacturer must report that event in the timeline as follows. Case Reporting Reporting deadline Timeline Serious public Immediately (without any Not later than 2 calendar days after awareness health threat delay that could not be by the manufacturer of this threat. justified) Death or Immediately (without any Not later than 10 calendar days following the serious incident delay that could not be date of awareness of the event. Other justified) after the Not later than 30 calendar days following the manufacturer established a date of awareness of the event. Incidents link between the device and the event Adverse events that result in a serious public health threat must be reported immediately within 48 hours through any convenient channel such as Telephone, walk in, letter or email followed by a written completed report within 15 days. If after becoming aware of a potentially reportable incident there is still uncertainty about whether the event is reportable, the manufacturer must submit a report within the timeframe required for that type of incident. The incident reports submitted by the manufacturers to EFDA may be in the form of: 1. Initial report: the first information submitted by the manufacturer about a reportable event, however, the information could be incomplete and supplementary information will need to be submitted. This includes immediate notification. It also includes a timeline for submitting follow-up reports upon the investigation performed by the manufacturer. followed by a written completed report within 15 days 2. Follow up report: a report that provides supplemental information about a reportable event that was not previously available. 3. Final report: the last report that the manufacturer expects to submit about a reportable event. It is a written statement of the outcome of the investigation and of any action. 4. Trend report: information supplied as a result of follow up and establishment of trends of adverse events associated with the use of medical devices.
3.2.3
Adverse event/ Incident should be reported in a Manufacturer Medical Devices reporting form as provided in Annex II and it should be appropriately filled in and submitted to EFDA either as a hard copy or via e-mail (mdsafety@efda.gov.et). The form can also be submitted through Manufacturers’ local representatives.
3.2.4
In general, the AE/incident report which occurred in Ethiopia should be submitted - according to the previously mentioned timeframes- to the medical device Vigilance& PMS desk of Ethiopian Food and Drug Authority.
3.3
All potential Use Error events and potential abnormal use events should be evaluated by the manufacturer. The evaluation is governed by risk management, usability engineering, design validation, and corrective and preventive action processes. Results should be available and reported to the Authority.
3.3.1
Use Error related to medical devices, which did result in ● death or ● serious deterioration in state of health or ● Serious public health threat, should be reported by the manufacturer to the Authority. Use Errors become reportable by the manufacturer to the authority when a manufacturer: ● notes a significant change in trend (usually an increase in frequency), or a significant change in pattern of an issue that can potentially lead to death or serious deterioration in state of health or public health threat) ● or initiates FSCA to prevent death or serious deterioration in state of health or serious public health threat.
3.4
EFDA may accept from a manufacturer or authorized representative periodic summary or trend reports, after one or more initial reports have been issued and evaluated by the manufacturer and the Authority. This should be agreed between manufacturers and the Authority and submitted in an agreed format and frequency for certain types of device and incidents. When a manufacturer has received the agreement of the NRA of other countries to switch to periodic summary reporting or trend reports, it shall inform EFDA about this agreement and of its modalities. Conditions for Periodic safety Summary Reporting under the Medical Device Vigilance System are:
3.4.1
Incidents specified in the field safety notice that occur after the manufacturer has issued a field safety notice and conducted a field safety corrective action need to be reported to the Authority. The manufacturer shall agree with the authority on the frequency and content of the periodic Safety summary report. Example: A manufacturer issued a field safety notice and conducted a field safety corrective action of a coronary stent that migrated due to inadequate inflation of an attached balloon mechanism. Subsequent examples of stent migration were summarized in quarterly reports concerning the field safety corrective action and individual incidents did not have to be reported.
3.4.2
Common and well-documented incidents (identified as such in the risk analysis of the device and which have already led to incident reports assessed by the manufacturer and the authority) may be exempted from reporting and changed to periodic Safety summary reporting. However, these incidents shall be monitored and trigger levels determined. Trigger levels for interim reporting should also be agreed with the authority. An interim (trend) report should be made whenever trigger levels are exceeded.
3.5
Trend reports
3.5.1
A trend report to EFDA should be made where there is a significant increase in the rate of: ● Already reportable incidents. ● Incidents that are usually exempt from reporting. ● Incidents that are scheduled for periodic reporting irrespective of whether Periodic Safety summary reporting has been agreed. To enable this, the manufacturer should have a suitable quality management system (QMS) in place for proactive scrutiny of trends in complaints and incidents occurring with their devices.
3.5.2
Based on the diversity of the medical devices in the market it is not meaningful to define a single trending procedure valid for all devices. Depending on the type of device (e.g. IVD, implant, diagnostic and therapeutic device, surgical and dental instrument, hearing aid, compression, etc.), the devices risk classification, the number of products delivered, single or multiple use of devices, devices with traceability requirements, unavailable information on device disposals and other parameters a manufacturer must adopt a trending procedure which is applicable and adequate for this operations and devices. Basic methods for performing trending can be found in the literature (e.g. for statistical quality control).While for many manufacturers the use of simple graphs and charts will be sufficient, the implementation of more sophisticated methods will be advisable for others. It is important that valid statistical methods are used for trend evaluation. The Authority may request the manufacturer to demonstrate that the applied method is appropriate for the case.
3.5.3
Complaint trending as an established quality system requirement provides the basis on which manufacturers are asked to accumulate and analyze their data. Since complaints come from the data source from which reportable adverse incidents are identified, trending of adverse events uses essentially the same methods as trending of complaints, for both trending processes the database, in the form of the complaint file, is the same. The method for the trend evaluation of both complaints and adverse events can be the same while the decision making process and the following activities are different and only trending of adverse event lead to reporting to EFDA.
3.6
Investigations
3.6.1
The manufacturer normally performs the investigation, while the Authority monitors progress. Timeframe(s) for follow up and/or final reports should be defined. If the manufacturer is not able to perform the investigation of an incident, then this should be informed to the Authority without delay. The Authority may intervene or initiate independent investigation if appropriate. This should be in consultation with the manufacturer where practicable. Note: The above principles are generalized and do not take account of interventions by judicial or other agencies.
3.6.2
A manufacturer may consult with the user on a particular incident before a report has been made to the Authority. The manufacturer may also need to have access to the device suspected to have contributed to the incident for the purpose of deciding whether the incident should be reported to the Authority. The manufacturer should in such cases make reasonable efforts to gain access to the device and may request support from the Authority to gain access to the device so that testing can be performed as soon as possible. Any delay can result in loss of evidence (e.g. loss of short term memory data stored in the device software; degradation of certain devices when exposed to blood) rendering future analysis of the root cause impossible. If the manufacturer gains access to the device, and his initial assessment (or cleaning or decontamination process) will involve altering the device in a way which may affect subsequent analysis, then the manufacturer should inform the Authority before proceeding. The Authority may then consider whether to intervene. Due to the frequency of these requests, a statement introduced in the initial report should cover this requirement, e.g. ―The manufacturer will assume destructive analysis can begin 10 days following issuance of this initial incident report, unless the Authority contacts the manufacturer within this time frame opposing a destructive analysis of the device‖. NOTE: This section also applies to samples and any other useful information associated with the incidents.
3.7
Outcome of an Investigation and Follow-up
3.7.1
The manufacturer shall take the action necessary following the investigation, including consultation with the Authority and performing any FSCA. The Authority may take any further action it deems appropriate, consulting with the manufacturer where possible.
3.7.2
The manufacturer shall provide a follow-up-report to the Authority if the investigation time reaches the timeline proposed and agreed with the Authority during the initial report.
3.7.3
There shall be a final report which is a written statement of the outcome of the investigation and of any action. Examples of actions may include: ● no action; ● additional surveillance of devices in use; ● preventive action on future production; ● FSCA. The report is made by the manufacturer to the Authority following the initial report. If the Authority performs the investigation, then the manufacturer shall be informed of the result. A recommended format for the manufacturer's final report is given in annex IV.
3.8
A field safety corrective action is an action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device that is already placed on the market. Such actions should be notified via a field safety notice. For further details on FSCA and FSN handling, product recall, and post-market surveillance (PMS), the reader is advised to refer to the EFDA Guideline on Field Safety Corrective Action, the EFDA Guideline on Recall of Medical Devices, and the EFDA Guideline on Post-Market Surveillance of Medical Devices, respectively. This Guideline addresses vigilance reporting only; it does not duplicate the procedural requirements of those dedicated guidelines.
CHAPTER FOUR: RESPONSIBILITIES OF USERS AND
GUIDANCE ON REPORTING User’s active involvement in the Vigilance System is crucial for quality health care service. Furthermore, for the successful operation of the vigilance system to be established, their involvement is vital. It is through the users that suspected incidents are made known to the manufacturers and with their close involvement and co-operation that the implementation of FSCAs is made possible. The involvement of users is promoted and encouraged through the relationship the manufacturer develops with customer (the user). Patients or users are encouraged to report immediately any suspected adverse events associated with the use of a medical device to a facility where the device was obtained or at the nearest health facility, health care provider, or directly to the Authority. Any person, who has the concern on the device, can report the adverse event to the authority on time as per the reporting format indicated on Annex V. The report format shall contain; device information, adverse event information and users/reporter’s information. However, any report should not be unduly delayed because of incomplete information or uncertainty about whether the event is reportable.
4.1
Reporting Guidance
4.1.1
Users or healthcare professionals responsible for reporting medical device incidents should report those meeting the criteria in this guideline to the manufacturer and/or authority. Initial incident reports should contain as much relevant detail as immediately available. Refer to Annex I for reportable AEs
4.1.2
Users are encouraged to report all adverse events/ incidents as soon as possible. Adverse events/incidents ought to be reported immediately as soon as by phone (toll free 8482), MDAER e-reporting portal or email. Thus events that result in death, serious injury or represent a serious public health threat ought to be reported by the fastest means possible. Incident reports should contain as much relevant detail as immediately available, but reporting ought not to be delayed for the sake of gathering additional information.
4.1.3
The users are encouraged to use the "Adverse Event Reporting form for user and Health care Professionals" indicated in Annex V in accordance with this guideline and to provide contact details when reporting to the manufacturer or EFDA. The form ought to be appropriately filled in and submitted via postal mailing, electronically (email or e-reporting platform of the authority, social media) or physically to the MDV& PMS desk of the Authority. Furthermore, the authority accepts reporting of such events orally and with free toll 8482. All reports submitted will be kept confidential.
4.1.4
In general, the adverse event/incident report shall be sent as convenient to: Medical Device Vigilance & Post market surveillance desk of EFDA EFDA branch offices and regional regulatory bodies and Manufacturer of the device or Authorized representative
4.1.5
All items, together with relevant packaging materials, ought to be quarantined; they ought not to be repaired or discarded. The device should be returned to the manufacturer in accordance with their instructions unless otherwise required by the Authority or other legal requirements. Users ought to contact the manufacturer to obtain information relating to the procedure for returning the suspect device. The device should be appropriately decontaminated, securely packaged, and clearly labeled, including the manufacturer reference number if needed. Medical devices ought not to be sent to the Authority unless it has been specifically requested. 4.1.6. Further local information Reporters are encouraged to cooperate with the manufacturer and EFDA by providing further information ● Concerning incidents which should become available e.g. relevant outcomes of internal investigations. ● Concerning the device or patient outcomes e.g. subsequent death.
4.2
Field Safety Corrective Action Guidance
4.2.1
Field Safety Notices are an important means of communicating safety information to medical device users in all healthcare areas. Field Safety Notices may also be used to provide updated information and request feedback. It is therefore important that users are encouraged to develop effective closed loop systems that ensure the dissemination of the Field Safety Notices and the timely completion of the actions outlined.
4.2.2
Healthcare facilities should be encouraged to help ensure that the FSN reaches all in the organization that needs to be aware and/or take the recommended action.
4.2.3
Users responsible for the maintenance and the safety of medical devices are encouraged to take the actions advised in the manufacturer’s field safety notice. These actions ought to be taken in cooperation with the manufacturer where required. They may also include associated actions recommended by the Authority in connection with the FSCA, including providing any requested feedback.
4.2.4
Users responsible for the maintenance and the safety of medical devices are encouraged to. a) Facilitate manufacturer access to the device if this is required, and b) Work with the manufacturer when needing to balance the individual risks and benefits for any dependent patients using affected devices.
CHAPTER FIVE: RESPONSIBILITY OF EFDA
CHAPTER FIVE: RESPONSIBILITY OF EFDA
5.1
other systems Receive an incident report from manufacturers, users, Health care Professionals, EFDA branch offices and regional regulatory bodies. A report which appears to meet the criteria of section "what to be reported ", received by the Authority from a User reporting system or other source, shall inform the Manufacturer without delay within 48 hours to 15 days depending on the risk/public health threat. In doing so, patient and/or Reporters confidentiality should be maintained. Send an acknowledgement of receipt to the Reporter. EFDA shall protect the identity of patients, reporters, and, where legally permissible, commercially confidential information submitted as part of a vigilance report, disclosing such information only to the extent necessary to protect public health, to comply with legal obligations, or with the consent of the person concerned.
5.2
Risk evaluation.
5.2.1
relevant: Assessment of risk will conduct on received incidents or FSCA reported including: ● Acceptability of the risk, taking into account criteria such as: causality, technical/other cause, probability of occurrence of the problem, frequency of use, detectability, probability of occurrence of harm, severity of harm, intended purpose and benefit of the product, the Medical Device safety principles, potential user(s), affected populations etc ● Need for (what) corrective action. ● Adequacy of measures proposed or already undertaken by the manufacturer. This assessment should be carried out in cooperation with the manufacturer.
5.2.2
The Authority monitors the investigation being carried out by the manufacturer. However, it may intervene at any time. Such intervention shall be in consultation with the manufacturer where practicable. Aspects of the manufacturer's investigation which may be monitored include, for example: Course (direction the investigation is taking); Conduct (how the investigation is being carried out); Progress (how quickly the investigation is being carried out); Outcome (whether the results of device analysis are satisfactory). Facts which may be needed include, for example: The number of devices involved. The length of time they have been on the market. Details of design changes which have been made. Cooperation may be needed with: Notified Bodies (involved in the attestation leading to the CE marking); Users and Health Care Professionals. Other Competent National Regulatory Authorities. Other independent bodies, test houses etc.
5.2.3
The Authority may also monitor experience with the use of devices of the same kind (For instance, all mechanical ventilators or all Infusion pumps), but made by different manufacturers. They may then be able to take harmonized measures applicable to all devices of that kind. This could include, for example, initiating user education or suggesting re-classification.
5.3
The authority’s actions as a result of a report of the manufacturer or authorized representative may include, for example: No further action: (for those compliant which were not justified on the base of investigation) Gathering more information (for example by commissioning independent reports); Making recommendations to manufacturers (for example to improve information provided with the device); Consult with medical device registration /inspection departments at EFDA on matters relating to the conformity assessment that require Regulatory Action Further user education. Further recommendations to user(s). Any other action to supplement manufacturer action. NB: The AE reports may identify unexpected adverse effects. Such findings can lead to changes such as refinement of instructions of use or introduction of specific warnings. When a hazard is considered unacceptable, a medical device may be withdrawn from the market. For drug device combination products regulated under the medical device directives, when MDV&PMS desk receive the incident report it should establish a link with any other relevant department of EFDA, if required.
5.4
Careful consideration should be given to the mode of communication, the drafting (content) and the dissemination of information by the authority. The possible positive and negative effects of the information to be disseminated should be considered when drafting advisory notifications and when selecting the means and medium by which the message is transmitted. When the manufacturer has informed the authority. In advance of the start of a FSCA; this information should be held confidential until the information becomes public. In general, preference should be given to notification communicated directly to medical practitioners or health-care facilities concerned, over communication to the public. In some cases, dissemination of information directly to the public may be needed e.g. to suggest that patients or users contact their medical practitioner for further, more specific advice. Where appropriate, it is recommended that the communication includes a statement indicating that medical practitioners or other health-care professionals should be consulted, and that the information is intended for medical professionals only. The authority should revise the press statement and the information for dissemination prepared by the manufacturer. Interfaces with communication media should be coordinated wherever practicable between the manufacturer and the authority.
5.5
The Authority shall place the manufacturer's final report on file and make any other observations necessary. The investigation files may then be endorsed as "complete". The manufacturer’s final report shall also be copied to any NRAs who were informed by the Authority of the initial report. The Authority should ensure the completion of each investigation conducted by the manufacturer and issue a confirmation for closure. The MDV& PMS desk in cooperation with the medical device manufacturer’s inspection and enforcement desk should inform the manufacturer when the investigation is complete, or if no additional investigation by the manufacturer is required. If the authority investigate the AE by itself, the manufacturer (and, where appropriate, other NRAs) shall be informed of progress and of the results. Records of incident reports shall be retained to enable the investigation to be reopened if necessary, and to facilitate systems for trend analysis. EFDA and manufacturers shall retain all vigilance-related records, including initial, follow-up, final and trend reports, investigation files, and correspondence, for a period consistent with the expected lifetime of the device concerned and in any case for not less than the retention period specified in EFDA's document control procedures, to ensure traceability of regulatory decisions and support periodic audit of the vigilance system. Furthermore, The Authority has the following responsibilities: a. Develop, review and distribute adverse events/incidence reporting tools and collect reports of adverse events/incident from the market, b. Acknowledge receipt of adverse events/incident reports from users, importers/man c. Conduct awareness creation workshops to health professionals and other stakeholders on detection, reporting of medical Device AE/incidents. d. Create media promotion, public mobilization and awareness creation on reporting Medical device adverse events. e. Analyse trend reports, periodic safety reports and other related reports. f. Identify signals and take appropriate regulatory action(s) based on signals generated. g. Conduct risk evaluation including risk assessment of an incident or FSCA reported and monitoring of manufacturers subsequent actions. h. Collect incident reports and communicate immediately to all responsible stakeholders when an adverse event/ incident has been reported and should issue a press statement once the adverse event /incident has been confirmed. i. Provide feedback to reporters. j. The authority monitors the investigation of the incident carried out by the manufacturer. k. Take any further action that may be necessary to supplement the actions of the manufacturer. l. Periodically publish, through its official website or bulletins, aggregate and de- identified information on vigilance activities, including the number of reports received and assessed, significant safety signals identified, and regulatory actions taken as a result, in order to promote public confidence and support informed use of medical devices Annexes
Annex I — Examples of incidents and field safety corrective actions which the manufacturer should report.
manufacturer should report. The following examples are for illustrative purposes only and are for the guidance of the manufacturer in determining whether a report should be made to National Medical Device Vigilance Center . The examples are intended to show that there is a considerable judgmental element in the decision on whether to report. Examples of the reportable incidents 1. A patient dies after the use of a defibrillator and there is an indication of a problem with the defibrillator. The incident should be reported. 2. A patient receives a burn during the use (in accordance with the manufacturer's instructions) of surgical diathermy. If the burn is significant, this should be reported as such a serious deterioration in state of health is not normally expected. 3. An infusion pump stops, due to a malfunction of the pump, but fails to give an appropriate alarm; there is no patient injury. This should be reported as in a different situation it could have caused a serious deterioration in state of health. 4. An infusion pump delivers the wrong dose because of an incompatibility between the pump and the infusion set used. If the combination of pump and set used was in accordance with the instructions for use for either pump or set, then the incident should be reported. 5. An aortic balloon catheter leaked because of inappropriate handling of the device in use, causing a situation which was potentially dangerous to the patient. It is believed that the inappropriate handling was due to inadequacies in the labeling. 6. A catheter fractured during insertion, with no suggestion of inappropriate handling. The fracture occurred in such a position that the broken part could easily be withdrawn. However, this was clearly a fortunate circumstance as if the catheter had fractured in a slightly different position, then surgical intervention would have been necessary to retrieve the broken end. 7. Glass particles are found in a contact lens vial. 8. Loss of sensing after a pacemaker has reached end of life. Elective replacement indicator did not show up in due time, although it should have according to device specification. This incident should be reported. 9. On an X-ray vascular system during patient examination, the C arm had uncontrolled motion. The patient was hit by the image intensifier and his nose was broken. The system was installed, maintained, and used according to manufacturer’s instructions. This incident should be reported. 10. The premature revision of an orthopedic implant is required due to loosening. Although no cause is yet determined, this incident should be reported. 11. manufacturer provides insufficient details on cleaning methods for reusable surgical instruments used in brain surgery, despite obvious risk of transmission of CJD. 12. A batch of out-of-specification blood glucose test strips is released by the manufacturer. A patient uses the strips according to the manufacturer’s instructions, but the readings provide incorrect values leading to incorrect insulin dosage, resulting in hypoglycemic shock and hospitalization. This incident should be reported. 13. A customer reports a wrong assignment of analytical results to patient codes by an automated analyzer. An evaluation could reproduce the effect and indicated that under specific conditions a data mismatch could occur. Due to the data mismatch a patient suffered from wrong treatment. This incident should be reported. 14. During maintenance of a self-testing analyzer for patients it was detected that a screw which places the heating unit of the analyzer in exact position had come loose. Due to this fact, it may happen that the heating unit leaves its position, and the measurement is performed under non exact temperature, which would lead to wrong results. As this could lead to wrong treatment of the patient this should be reported. Examples of reportable FSCA 1. The manufacturer of a pacemaker has identified a software bug in a pacemaker that has been placed on the market. The initial risk assessment identified the risk of a serious deterioration in state of health as remote. Subsequent failure results and the new risk assessment carried out by the manufacturer indicate that the likelihood of occurrence of a serious deterioration in state of health is not remote. The FSCA should be reported. 2. Fatigue testing performed on commercialized heart valve bio prosthesis demonstrates premature failure, which resulted in a risk to public health. The FSCA should be reported. 3. A defect is discovered in one (hitherto unopened) sample of a batch (lot) of a contact lens disinfecting agent that could lead to incidence of microbial keratitis in some patients. The manufacturer initiates a FSCA of this batch. This should be reported as an FSCA. 4. During stability testing of a CRP test the internal quality control found that after several months of storage false increased values are measured with neonatal samples. This could lead to the wrong diagnosis of the existence of an inflammatory illness and to a wrong treatment of the patient. The manufacturer issues information to the field that a reduced onboard stability has to be taken into account. The FSCA should be reported. 5. A manufacturer has noticed that starting from control lot XX a lower recovery is obtained and re-assigns the control value. Users are informed of this new value by means of warning stickers and customer communication. The FSCA should be reported.
ANNEX II — Manufacturer Initial Report Form
A. Report Information Case reference number (assigned by EFDA on receipt) Date of this report B. Device Identification Trade name Model / catalogue number Manufacturer / MAH name and address Batch / serial / UDI GMDN code Risk classification C. Event Information Date of event Date manufacturer became aware Description of the event (what happened, in what setting) IMDRF Annex A — Device Problem (select all that apply) ☐ Device operated differently than expected ☐ No apparent device problem ☐ Material/component deficiency ☐ Alarm/signal problem ☐ Failure to alarm or alert ☐ Electrical/electronic problem ☐ Software problem/application deficiency ☐ Physical damage (break/cut/tear/puncture/crack) ☐ Contamination ☐ Infusion or flow problem ☐ Other (specify below) IMDRF Annex E — Health Effect: Clinical Sign/Symptom/Condition (select all that apply) ☐ Death ☐ Hemorrhage ☐ Infection ☐ Allergic/immunological reaction ☐ Burn ☐ Pain ☐ Neurological signs/symptoms ☐ Cardiac/vascular signs/symptoms ☐ No clinical signs/symptoms IMDRF Annex F — Health Effect: Health Impact (select the most severe that applies) ☐ Death ☐ Life-threatening injury/illness ☐ Hospitalization (initial or prolonged) ☐ Disability/permanent impairment ☐ Congenital anomaly/birth defect ☐ Intervention required to prevent permanent impairment ☐ No health impact D. Distribution Countries where marketed Number of devices distributed/at risk Initial actions already taken (e.g., quarantine, preliminary review) E. Reporting Firm and Declaration Reporting firm name and address Contact person, telephone, email Name and position of person completing this report Signature (or electronic equivalent) and date Submission of this report does not, in itself, represent a conclusion by the manufacturer or EFDA that the report is complete, or that the device caused or contributed to the reported outcome.
ANNEX III — Manufacturer Follow-Up Report Form
Case reference number Date of this Follow-Up Report Trade name / model Batch / serial / UDI Investigation status ☐ Investigation ongoing ☐ Awaiting external/laboratory result ☐ Awaiting device return ☐ Investigation complete — Final Report to follow New information obtained since the Initial Report (or previous Follow-Up Report) Interim actions taken, if any Revised expected completion date Reason for any delay against Section 5.1 timeline Name and position of person completing this report Signature (or electronic equivalent) and date
ANNEX IV — Manufacturer Final Report Form
Case reference number Date of this Final Report Trade name / model Batch / serial / UDI IMDRF Annex B — Type of Investigation Performed (select all that apply) ☐ Device evaluation performed by manufacturer ☐ Device evaluation not performed (device not returned) ☐ Device evaluation not performed (device not evaluable) ☐ Third-party laboratory evaluation ☐ Root cause analysis ☐ Software/firmware code review IMDRF Annex C — Investigation Findings (select all that apply) ☐ No abnormalities/no failure found ☐ Component/material failure confirmed ☐ Software anomaly confirmed ☐ Manufacturing deviation confirmed ☐ Design deficiency confirmed ☐ Evidence of use error ☐ Evidence of abnormal use ☐ Evidence of maintenance/service deficiency IMDRF Annex D — Investigation Conclusion (select the applicable conclusion) ☐ Device caused or contributed to the event ☐ Device did not cause or contribute to the event ☐ Insufficient information to determine device involvement ☐ Event attributable to underlying disease/condition ☐ Event attributable to use error, not device deficiency IMDRF Annex G — Medical Device Component Involved (select if applicable) ☐ Battery/power supply ☐ Software/firmware ☐ Alarm system ☐ Connector/coupling ☐ Sensor ☐ Housing/casing ☐ Packaging ☐ Accessory (specify below) ☐ Not applicable Narrative summary of investigation findings and root cause Corrective and/or preventive action taken or planned, if any Causality category assigned Case status Name and position of person completing this report Signature (or electronic equivalent) and date
ANNEX V — Reporting Form for Healthcare Facilities, Health Professionals, Patients, Users, and Caregivers
Patients, Users, and Caregivers You do not need any technical knowledge to complete this form. Providing your name and contact details is optional; you may report anonymously. If the event involved death or a serious risk to health, please also telephone or email the Authority immediately, in addition to completing this form. I am reporting as a: ☐ Health professional ☐ Healthcare facility (on behalf of) ☐ Biomedical engineer/maintenance personnel ☐ Importer/distributor/wholesaler ☐ Patient ☐ User/caregiver ☐ Other Your name (optional) Contact details (optional): phone/email Facility/organization name, if applicable Date of this report Device name/brand (as printed on the device or Model/batch/serial number, if visible packaging) What happened? Please describe the event in your own words, including date, and what the device was being used for What happened to the patient/user as a result, if anything? Have you kept the device and its packaging? ☐ Yes ☐ No ☐ Not applicable Would you like to be contacted about the outcome of this report? ☐ Yes ☐ No / prefer to remain anonymous
ANNEX VI — Trend Report Form
Trade name / device family GMDN code Reporting period covered (from / to) Denominator used (units distributed/in use) Trend trigger relates to (select all that apply): ☐ A specific IMDRF Annex A device-problem term ☐ A specific IMDRF Annex E/F health-effect term ☐ Overall event rate/frequency Device problem / health effect term(s) that triggered this report Number of events in this period Rate (events per denominator) and prior-period comparison Manufacturer's evaluation of cause and clinical significance Action taken or planned (e.g., further investigation, design/label review), or justification for no further action Name and position of person completing this report Signature (or electronic equivalent) and date
ANNEX VII — Periodic Safety Summary Report Form
Trade name(s) / device family GMDN code(s) Reporting period covered (from / to) Risk classification Summary of all events reported during this period, by IMDRF Annex A/E/F term (including sub-threshold events not individually reported) Status of investigations open at the start of this period (updates since last report) Investigations closed during this period, with causality outcome for each Any Trend Reports (Annex VI) submitted during this period Overall conclusion for this reporting period Name and position of person completing this report Signature (or electronic equivalent) and date