FAQEU

EU Medical Device Regulation (MDR) 2017/745 FAQ

Fast answers to high-signal MDR questions.

Use the linked topic pages for deep dives and templates (classification memo, technical file index, CER structure, PMS plan, UDI/EUDAMED).

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Author

Sorena AI

Published

Feb 22, 2026

Updated

Feb 22, 2026

Questions

Structured answer sets in this page tree.

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Cited legal and guidance references.

Publication metadata

Sorena AI

Published Feb 22, 2026

Updated Feb 22, 2026

Overview

This FAQ focuses on the questions that materially change your MDR route, cost, and timelines. For edge cases (borderline products, novel software outputs, combination products), use the Applicability test and Device classification guide pages to document a defensible memo and update it when your claims or functionality changes.

Question 1

Scope and classification

These questions decide whether MDR applies and what route you follow. Write the answer into a memo, not just a meeting note.

If you only do one thing, keep a versioned scope memo and classification memo.

Is my product a medical device under MDR? Start with intended purpose and claims, not the technology or the marketing category.
Is my software a medical device? If it provides information used for diagnosis, monitoring, or treatment decisions, or drives a device, treat qualification and Rule 11 seriously.
Do I need a notified body? Usually yes for class Is, Im, and Ir devices and for class IIa, IIb, and III devices. Standard class I devices often self-declare, but still need the full technical file and PMS controls.
Which class decides the legacy transition end date? Use MDR Annex VIII classification logic for the 31 December 2027 or 31 December 2028 transition end-date analysis, even if the old directive certificate shows a different class.
What is the fastest way to avoid classification churn? Keep the label, IFU, UI output, clinical claims, and classification memo aligned under change control.

Question 2

Technical documentation and QMS

These questions decide how defensible the file is when a notified body or competent authority asks for proof.

Treat Annex II and III documentation and the QMS as live operating assets.

What goes in the technical file? Use Annex II and III as the index: device description, design and manufacturing information, GSPR checklist, V and V evidence, labeling, PMS plan, and PMS outputs.
What is PRRC? Under Article 15, manufacturers need at least one qualified person responsible for regulatory compliance. Micro and small enterprises may keep that person permanently and continuously at their disposal rather than inside the organisation.
What changed under Article 10(9)(h)? The QMS must verify UDI assignments and ensure consistency and validity of the Article 29 registration data.
What do importers need to verify? They verify required registrations and add their own details in Article 31 scope, so do not treat importer data as optional admin work.
What changes most often fail audits? Uncontrolled claim changes, undocumented software releases, stale GSPR traceability, and PMS outputs that do not update the rest of the file.

Question 3

Clinical evaluation, PMS, vigilance, and EUDAMED

These questions decide whether you can justify safety and performance after launch, not just before launch.

Operational rule: if post-market findings do not visibly update risk management, CER, and registration records, the system is not mature.

What is the PSUR cadence? Class IIb and class III at least annually, class IIa at least every two years. Class I devices use a PMS report instead of a PSUR.
What are the serious-incident timelines? Article 87 uses 15 days for a general serious incident, 2 days for a serious public-health threat, and 10 days for death or unanticipated serious deterioration in a person's state of health.
How do UDI and EUDAMED work together? UDI is the identification system, while EUDAMED is the database environment for actors, devices, certificates, and later full vigilance workflows.
What changes on 28 May 2026? The first four EUDAMED modules become mandatory to use, so actor, device, and certificate data quality must be operational before then.
What about legacy devices and transition? Transition only survives while the Article 120 conditions remain true, including no significant changes and, where relevant, the 2024 application and written-agreement milestones.

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