🇷🇸 Serbia medical device regulatory data

Only a medical device that complies with the essential requirements, or which is registered, may be advertised. Advertising must be truthful, scientifically proven and professional, must not mislead the public, and may not present illness or treatment success in a misleading, self-regulation-implying or sensationalist manner. Advertising to the general public and to the professional public is distinguished; the Minister prescribes conditions and manner of advertising (Pravilnik o oglasavanju medicinskog sredstva, 102/2018, ispravka 105/2018); ALIMS controls promotional material on the Ministry's proposal.

A registration decision is issued for a validity period ending 60 days after the expiry date of the certificate of conformity. For Class I devices (other than Is and Im classes; bylaw also excludes Ir) and other in vitro diagnostic devices (IVD class A) placed on the market on the manufacturer's Declaration of Conformity, the registration decision is granted for five years from issuance. Devices may remain on the market at most 90 days after the registration decision expires; import is not possible for a device whose registration expired without a timely renewal request.

The manufacturer or authorised representative must file the renewal request at least 30 days before expiry of the registration decision; ALIMS decides within 15 days based on the valid conformity document and prescribed documentation. Renewal may include amendments at the applicant's request. If no renewal request is filed, ALIMS removes the device from the Register without a removal decision; the AR whose mandate ended must file removal from the Register of Manufacturers without delay. The device must be placed on the market within 12 months of the renewal decision.

Agencija za lekove i medicinska sredstva Srbije (ALIMS, Medicines and Medical Devices Agency of Serbia) is the competent authority for medical devices: it performs registration, amendments, renewal and removal from the Register of Medical Devices, keeps the Register of Manufacturers/authorised representatives, recognises foreign conformity documents and CE marking, approves and controls clinical trials, conducts market surveillance and vigilance, determines product status (whether a product is a medical device), and approves import of unregistered devices.

The Ministry of Health exercises inspection supervision through a medical devices inspector, issues manufacture and wholesale distribution licences, decides classification disputes between manufacturer and conformity body on a prior ALIMS opinion, and may prohibit marketing and order withdrawal of devices.

A request or notification is required for every amendment of Register data; ALIMS decides within 15 days. Changes that do not affect safety and performance (e.g. graphic design of packaging/IFU, text layout changes, adding another foreign language on packaging/IFU) are only reported (prijava) and entered in the Register without a decision, with a confirmation of the filed change issued. Changes requiring a decision include: change of AR, manufacturer, notified/appointed body, device name, class or category, shelf life, storage conditions, place of issue/sale, testing procedures/design/materials, and alignment with EU regulations with updated certificates (added 6/2023). The device must be placed on the market within 12 months of the amendment decision/notification.

A clinical investigation of a medical device may be conducted only if the benefit exceeds the potential risk to subjects, ALIMS has approved the conduct, and the Ethics Committee of Serbia has given a positive opinion (given in a parallel procedure); informed consent (written, signed, dated) is required, and the trial may be performed only at a healthcare institution contracted with the sponsor, by employed healthcare professionals, with records kept at least five years after trial end.

ALIMS must approve a clinical investigation within 40 days of receipt; if the application is incomplete ALIMS notifies within 5 days and the applicant completes within 20 days; the 40-day clock stops while supplementation is requested. The Ethics Committee of Serbia gives its opinion in a parallel procedure within 30 days (15-day supplementation, stop-clock). Approvals are published on the ALIMS website within 7 days.

In clinical investigations, the sponsor reports to ALIMS a serious adverse event requiring prompt corrective measures for other subjects/users, and new findings on such an event, within 2 calendar days of awareness; other reportable events within 7 calendar days. The investigator reports events to the sponsor per the approved protocol, at the latest 3 calendar days from awareness. Post-market non-interventional studies fall under the vigilance system.

An in vitro diagnostic medical device is any reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system intended for in-vitro examination of samples to provide information on physiological/pathological states, congenital anomalies, predisposition, compatibility, treatment response prediction or monitoring; sample receptacles are IVDs. An accessory is a product that is not a medical device but is specifically intended by the manufacturer to be used in combination with one; invasive sampling devices are general devices, not IVDs. ALIMS determines product status (whether a product is a medical device) on prescribed criteria.

A general medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other product used alone or in combination, including software provided by the manufacturer for diagnostic or therapeutic purposes, intended for diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, injury/disability compensation, anatomy/physiology modification, in-vitro examination information, conception control, or cleaning/disinfection/sterilisation of devices, whose principal intended action is not pharmacological, immunological or metabolic. Accessories are covered by the law.

For comparison with the manufacturer's original version the applicant also submits: outer/inner packaging proposal in English; for patient self-use devices the packaging proposal also in Serbian; IFU in English for foreign-origin devices and an IFU in Serbian for both foreign and domestic devices signed by a physician (for IVDs also by a biochemistry professional). Documentation is submitted to ALIMS in electronic form in Serbian (English accepted except for the IFU and patient self-use packaging proposals, which must be Serbian); paper submission is exceptional.

Registration dossier (bylaw Art. 10): (1) Declaration of Conformity (original in electronic or paper form, or certified copy); (2) EC Certificate (notified/appointed body certificate), except for Class I and other IVD devices (IVD class A); (3) for Class I / other IVD / IVD class A manufacturers from non-EU, non-MRA, non-PECA countries: an ISO 13485 / SRPS EN ISO 13485 quality management certificate from an accredited certification body, or proof the device is on the market in an EU/MRA state; (4) written authorisation of the foreign manufacturer for the AR with certified translation. Certificates may be submitted as scanned copies with a link to the issuing body for authenticity verification.

A change of authorised representative is defined by a contract concluded as a rule between the manufacturer, the outgoing and the incoming AR, containing at least: termination date of the outgoing and start date of the incoming AR; the date until which the outgoing AR may appear in manufacturer data and promotional material; transfer of documents including confidentiality and property rights; and the outgoing AR's duty to hand over complaints, quality and incident defects after mandate expiry. The manufacturer or the new AR must file the amendment request with ALIMS without delay; the request includes the AR change contract with a certified translation.

The registration application is submitted by: (1) the manufacturer (a manufacturer seated in Serbia, or a representative office/branch of a foreign manufacturer seated in Serbia), or (2) the authorised representative of the manufacturer. The AR must hold a written authorisation signed by the foreign manufacturer and the AR, covering at minimum: keeping technical documentation and certificates; providing documentation to the Ministry/ALIMS on request; executing ordered corrective/preventive measures; informing the manufacturer without delay of complaints, quality defects and incidents; and filing the AR removal request when replaced. The applicant must have a person responsible for documentation and a person responsible for vigilance.

An importer from non-EU countries may place on the market only devices for which conformity assessment has been carried out; before placing on the market it must verify that the manufacturer performed conformity assessment, appointed an authorised representative, prepared the declaration of conformity and technical documentation, that the device bears the conformity mark, is labelled with IFU and declaration, and carries a UDI or bar code where applicable. The importer is responsible for withdrawal of unregistered devices placed on the market under Art. 79 approvals.

The applicant must employ full-time a person responsible for documentation (completed medical, dental, pharmaceutical, technological, electro-technical, mechanical, chemical or legal faculty) and a person responsible for vigilance and market monitoring (same faculty types plus additional vigilance education). Exceptionally one person may hold both roles, decided by ALIMS depending on number of classes/categories represented and planned volume.

ALIMS may exceptionally authorise import of a medical device not registered in Serbia when intended for a particular patient or group of patients, as donation or humanitarian aid or an EU donation programme, for scientific research, or in an emergency. The device must undergo conformity assessment or an equivalent safety and performance assessment. The Minister prescribes conditions and manner (Bylaw on Import of Unregistered Medical Devices, 39/2018, 104/2018, 58/2021).

The Ministry of Health issues a manufacture licence for Class I devices (other than Is and Im), other IVD medical devices (class A), devices for which no conformity assessment is performed (not covered by a conformity mark), custom-made devices, devices for clinical investigation, and systems/kits. The licence decision is issued within 60 days; an incomplete request must be supplemented within 15 days; the 60-day clock stops while additional information is requested. Manufacturers seated in Serbia for other classes instead undergo conformity assessment by a body.

Wholesale of medical devices (including import, export, procurement, storage, distribution) may be performed only by a legal or natural person meeting requirements for space, equipment and personnel, holding a licence for wholesale distribution of medical devices and operating under good distribution practice guidelines prescribed by the Minister (GDP bylaw 94/2018). Wholesalers must ensure continuous market supply and keep distribution records.

ALIMS does not charge tariffs for activities relating to medical devices from donations and humanitarian aid, EU donation programmes, in emergency situations, or for activities performed at the request of the Ministry. The same exemption is restated in Art. 29 of the 2023 fee decision.

Where a device and accompanying equipment are used exclusively by healthcare professionals, the manufacturer may provide the instructions for use in electronic form instead of paper; before placing on the market it must carry out a risk assessment and ensure the electronic IFU poses no risk to public health.

Instructions for use accompanying devices on the Serbian market must be written in Serbian and fully comply with the original manufacturer's text; under the labelling bylaw the IFU is in Serbian, indelible, legible and comprehensible, is submitted to ALIMS at registration/renewal/amendment, and information necessary for safe use must be in Serbian (except packaging of devices for professional use).

Outer and inner packaging of devices for professional use must be marked in Serbian or English; devices the patient uses independently must be marked in Serbian (original packaging in Serbian, or foreign packaging with an additional Serbian sticker containing all prescribed data). Batch numbers must be marked where rational and feasible; the AR name and registration decision number may be on a sticker.

Law on Medical Devices (Zakon o medicinskim sredstvima), "Sl. glasnik RS" No. 105/2017, is the current statute. It entered into force on the eighth day after publication and applies 12 months after entry into force (i.e. fully applicable from late 2018 per ALIMS). On its entry into force, the medical-device part of the Law on Medicinal Products and Medical Devices ("Sl. glasnik RS" 30/2010, 107/2012) ceased to apply. Existing licences remained valid max 24 months and existing registrations until expiry of the term set in the decision.

Pravilnik o registraciji medicinskog sredstva (Bylaw on Registration of Medical Devices), "Sl. glasnik RS" 84/2018, 58/2021, 6/2023, prescribes the conditions and manner of recognition of foreign documents and the CE mark, the content of the application, the documentation, and the manner of registration, renewal, amendment and removal from the Register of Medical Devices, and the Register of Manufacturers.

Implementing bylaws under the Law on Medical Devices (all listed on ALIMS): essential requirements 65/2018; registration 84/2018, 58/2021, 6/2023; wholesale 84/2018; import of unregistered devices 39/2018, 104/2018, 58/2021; product status 65/2018, 58/2021; clinical investigation 91/2018, 40/2019; GDP guidelines 94/2018; production 102/2018, 58/2021; market monitoring 102/2018, 58/2021; advertising 102/2018 (ispravka 105/2018); suspension/withdrawal and technical assessment 99/2018, 37/2019; labelling and IFU 4/2019, 87/2024; in-house manufacture 4/2019; vigilance 3/2019; list of Serbian standards 28/2019.

The manufacturer must establish and maintain a post-market surveillance plan involving collection, analysis and investigation of every complaint, quality defect and incident reported by users, and keep records of non-compliant and withdrawn devices (custom-made and clinical-investigation devices excepted). The manufacturer/AR must continuously monitor the device on the market, keep a record of implemented corrective and preventive measures and report them to ALIMS; ALIMS may require a reasoned, evidence-based report on market experience.

Class I (except Ir, Is, Im) and other IVD/class A manufacturers compile a post-market surveillance report (summary of results, conclusions and preventive/corrective measures), updated as needed and submitted to ALIMS on request. Manufacturers of Class IIa, IIb and III devices, active implantable devices, IVDs and self-testing devices compile a Periodic Safety Update Report (PSUR) per device/category: Class IIb/III, active implantables, IVDs and self-testing devices update it at least annually; Class IIa as needed and at least every two years. For Class III, implantable and IVD List A/class D devices the PSUR is submitted to the conformity assessment body, which appends its assessment and makes it available to ALIMS.

The registration application is submitted on Obrazac 1 (Form 1), printed as an integral part of the registration bylaw and published by ALIMS in the 6/2023 version; it is completed in the part relating to registration and is accompanied by the device documentation and proof of fee payment. The attached device list requires trade name with types/models, generic device group, package content, GMDN/EDMA/EMDN and UDI coding, and catalogue numbers.

Incident reporting by the manufacturer/authorised representative to ALIMS is performed electronically through the Agency portal; if an initial report was given orally (e.g. by phone), a written report follows without delay. Initial, follow-up and final reports are submitted on Prilog 3, with manufacturer incident data per Prilog 4 of the vigilance bylaw.

Quality assurance of each batch of a medical device is performed in accordance with SRPS EN ISO 13485; a manufacturer without a certified quality management system per SRPS EN ISO 13485 performs quality assurance in accordance with the production bylaw itself. Contract manufacturing and contracted quality control agreements must be in writing and per SRPS EN ISO 13485.

The manufacturer must keep the technical documentation and the declaration of conformity after placing the device on the market for at least five years, and for implantable devices at least 15 years; it must also employ full-time a qualified person responsible for quality and vigilance, and hold a damage-insurance policy covering use of the device.

The manufacturer/AR must notify ALIMS without delay of any initiated Field Safety Corrective Action (FSCA). The manufacturer/AR and the wholesaler must have a plan for urgent withdrawal of devices from the market ensuring effective withdrawal at the request of the Ministry, the manufacturer or the AR.

The Ministry prohibits marketing and orders withdrawal of a device if it is harmful in normal use, fails its performance, has an unfavourable benefit-risk ratio, deviates from prescribed composition, lacks conformity assessment, is produced by an unregistered/unlicensed entity, has no registration request or certificate of conformity, is forged or suspected of forgery, has passed expiry, or is otherwise on the market contrary to law (whole device or a series). Withdrawal may also be ordered based on notices received through the EU/EEA rapid information exchange system or PIC/S. The wholesaler must withdraw devices subject to a ban. A manufacturer/AR deciding voluntarily to withdraw a device or series must inform the Ministry and ALIMS without delay.

Devices placed on the market must bear a CE marking or a Serbian conformity mark (Art. 17). Foreign certificates of conformity (certificate, test report, declaration of conformity, certificate of control issued by an EU notified body or accredited laboratory) and CE marking are recognised by ALIMS in the registration procedure; recognition may also be obtained as a separate procedure at the request of the manufacturer or authorised representative (bylaw Art. 3(2)). For non-harmonised devices, the Serbian conformity mark is affixed following conformity assessment by an appointed (imenovano) body.

ALIMS registers in the Register of Medical Devices each medical device for which conformity assessment has been carried out and which is placed on the market or into use; the application is submitted before placing on the market. Art. 50(2) states that registration in accordance with the law is not itself a requirement for placing on the market; trade of a registered device is performed on the basis of a valid registration decision (registration bylaw Art. 11(6)), and a device without a submitted registration request is a ground for market ban and withdrawal (Art. 84(1)(7)).

Trade (promet) of a registered medical device is performed on the basis of the valid registration decision; if a renewal request was filed and the validity term expired, the last decision's validity is extended until the renewal decision, but at most 90 days from expiry, and trade continues on the extended decision plus the completeness confirmation.

ALIMS must register a compliant device no later than 30 days from submission; if the request is incomplete ALIMS notifies the applicant within 15 days and the applicant must complete it within 30 days of the notice; the 30-day registration deadline stops running from the day ALIMS requests additional information and resumes from submission of the requested information. Registration data are published on the ALIMS website within 7 days of the decision.

If ALIMS does not issue a renewal decision within 15 days of receiving a complete renewal request, the device may remain on the market under the previously issued registration decision; under the bylaw the last decision's validity is extended until the renewal decision but at most 90 days from its expiry, with all applicant rights and duties continuing; ALIMS must notify the Ministry's inspectorate.

To prevent serious consequences for public health in an epidemic or other emergency, the Government, at the proposal of the Minister, may prescribe a different manner and conditions for placing devices on the market and their registration, clinical trials, manufacture, technical evaluation, labelling, vigilance, advertising and use than those prescribed by the Law.

The following devices are not registered: devices for which a clinical trial approval was issued; devices for continuation of treatment started outside Serbia for the personal use of a specific patient (on proposal of the competent healthcare professional of the country where treatment started); custom-made devices (which must bear a manufacturer/AR special-purpose statement and be labelled 'custom-made'); devices for scientific research and development; devices temporarily imported for exhibitions and fairs (with a visible warning that trade/use is forbidden); and devices manufactured in a health institution for use in that institution.

An appeal may be filed to the Ministry of Health against ALIMS decisions on registration and its amendments/renewal/removal, clinical trial approvals, pharmacopoeia compliance assessment, recognition of foreign documents and marks of conformity, technical assessment, product status determination, and import/export approvals. The Ministry's decision is final in the administrative procedure and an administrative dispute may be initiated against it. Entrusted tasks follow the general administrative procedure law unless the Law provides otherwise.

Wholesalers must keep records on type, number/quantity of devices sold in Serbia and all imported and exported devices (per pack), containing device name and description, manufacturer and AR name/address, quantity, registration decision number or import approval number, lot or serial number, UDI or bar code where applicable, and the consignee. Based on these records, the wholesaler and the manufacturer/AR submit to ALIMS a turnover and consumption report for the previous calendar year by 15 April at the latest.

The UDI-related provisions of the Law - the Unique Device Identification definition (Art. 2 item 98), the importer verification of UDI/bar code (Art. 80(2)(6)), and the UDI/bar code entry in wholesale records (Art. 85(2)(8)) - will be applied only as of the date of accession of the Republic of Serbia to the European Union.

ALIMS records and evaluates incidents defined as: (1) any malfunction or alteration of device characteristics or performance, and irregularities in marking or instructions for use, which led or could have led to death or serious deterioration of health of the patient or user; (2) any technical or medical reason related to performance causing the manufacturer/AR to withdraw devices of the same type from the market. Health institutions, private practice, healthcare workers, manufacturers, ARs, wholesalers, persons in distribution/delivery/putting into service, and persons responsible for calibration and maintenance must notify ALIMS without delay of any incident; health institutions appoint a vigilance coordinator reported to ALIMS.

Manufacturer/AR report to ALIMS, without delay after establishing the device-event link: a serious threat to public health at the latest within 2 calendar days of awareness; death or unexpected deterioration of health at the latest within 10 calendar days; other incidents at the latest within 30 calendar days. Where reporting obligation remains uncertain, the report is filed within the deadline for that incident type. Reporting is electronic via the Agency portal, with initial, follow-up and final reports on the prescribed annexes.