Annex I, 1–9
General safety and performance
Document intended purpose, foreseeable misuse, benefit-risk acceptability, risk controls, residual-risk communication, device lifetime, transport/storage, and performance evidence.
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EU MDR GSPR Checklist
Turn your device characteristics into a practical Annex I review list. Mark evidence as ready, identify gaps, and download a working summary for your technical documentation review.
Device-specific applicabilityBrowser-only draftDownloadable gap summary
Map applicable areas
Use device features to surface relevant Annex I sections.
Track evidence readiness
Mark evidence ready or capture gaps for follow-up.
Verify the legal text
Use the consolidated EU MDR as the controlling source.
Build your preliminary GSPR checklist
Select the characteristics that apply to your device. The checklist highlights the relevant Annex I evidence areas and saves progress in this browser.
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Applicable areas
6
Reviewed
0 / 6
Gaps identified
0
Annex I, 10
Chemical, physical and biological properties
Address material selection, compatibility, contaminants, residues, substances of concern, and biological safety for the intended contact and exposure.
Annex I, 11
Infection and microbial contamination
Control microbial risks through design, packaging, validated processing, sterility assurance, and clear handling or reprocessing information.
Annex I, 12
Materials of biological origin
Establish sourcing, processing, traceability, viral or transmissible-agent controls, and supporting safety evidence.
Not selected by the current device characteristics. Confirm this determination before excluding it.
Annex I, 13–14
Construction, environment and interoperability
Assess combination, connection, compatibility, environmental, maintenance, calibration, disposal, and reasonably foreseeable use risks.
Annex I, 15
Diagnostic or measuring function
Define accuracy, precision, stability, units, limits, calibration, and performance evidence appropriate to the intended measurement.
Not selected by the current device characteristics. Confirm this determination before excluding it.
Annex I, 16
Radiation protection
Minimize unintended exposure and document controls, warnings, shielding, dose information, and performance for intended radiation.
Not selected by the current device characteristics. Confirm this determination before excluding it.
Annex I, 17
Electronic systems and software
Cover lifecycle processes, verification and validation, cybersecurity, usability, data integrity, repeatability, and minimum hardware/network requirements.
Not selected by the current device characteristics. Confirm this determination before excluding it.
Annex I, 18
Active-device and electrical risks
Address electrical, thermal, mechanical, power-supply, alarm, single-fault, electromagnetic compatibility, and maintenance risks.
Not selected by the current device characteristics. Confirm this determination before excluding it.
Annex I, 19
Active implantable devices
Document implant-specific identification, compatibility, energy-source, reliability, programming, and patient information controls.
Not selected by the current device characteristics. Confirm this determination before excluding it.
Annex I, 20
Mechanical and thermal risks
Control movement, vibration, noise, pressure, dimensions, connection errors, accessible temperatures, and other mechanical hazards.
Annex I, 21
Energy or substances administered to the patient
Control delivery accuracy, flow, dose, unintended release, incompatibility, and failure modes for administered energy or substances.
Not selected by the current device characteristics. Confirm this determination before excluding it.
Annex I, 22
Devices used by lay persons
Make operation and result interpretation understandable, reduce foreseeable user error, and include verification or warning mechanisms where appropriate.
Not selected by the current device characteristics. Confirm this determination before excluding it.
Annex I, 23
Labeling, IFU and information supplied
Confirm labels, symbols, identifiers, warnings, contraindications, residual risks, performance claims, IFU content, translations, and electronic information.
Annex I, 11 & 23
Sterility and reprocessing information
Align labeling with validated sterilization, packaging integrity, shelf life, cleaning, disinfection, reprocessing limits, and disposal instructions.
Not selected by the current device characteristics. Confirm this determination before excluding it.
Keep the output as a working gap list
Your draft stays in this browser. Download a text summary to review with your quality and regulatory team.
How to use a GSPR checklist
For each applicable requirement, record the evidence location, standards or common specifications used, test methods, acceptance criteria, risk controls, and the conclusion. A simple “complies” statement is rarely enough to make the technical documentation easy to audit.
Review applicability against the intended purpose, risk management file, design inputs, verification and validation, clinical evaluation, usability engineering, cybersecurity, labeling, and post-market plans. Keep the matrix controlled as the design or applicable requirements change.
EU MDR GSPR checklist FAQ
What is a GSPR checklist?
A GSPR checklist maps the General Safety and Performance Requirements in EU MDR Annex I to applicability decisions, evidence, standards, test reports, risk controls, labeling, and other technical documentation.
Does every EU MDR Annex I requirement apply to every device?
No. Applicability depends on the device design, intended purpose, users, environment, and features. Each exclusion should be justified rather than assumed.
Is this checklist enough for CE marking?
No. It is a preliminary gap-assessment aid, not a conformity assessment or a complete technical documentation template. Manufacturers must use the current legal text and applicable standards and guidance.
Where is my checklist saved?
Progress is stored only in your current browser using local storage. It is not uploaded to Pure Global AI. You can also download a plain-text working summary.