Navigating IVDR together
IVDRLAB is an open platform where regulatory professionals, manufacturers, and students ask questions, share experience, and make sense of Regulation (EU) 2017/746 — from device classification and notified bodies to performance evaluation, technical documentation, EUDAMED, UDI, and post-market surveillance.
IVDR shouldn't be this hard to figure out
IVDR guidance is scattered across regulation texts, MDCG documents, forums, and expensive consultants — and it keeps changing. We bring it into one open community, so anyone working under Regulation (EU) 2017/746 can find clear answers and real-world experience in one place.
Practical Experience
Classification calls, technical documentation, and audit lessons — from real submissions, by people who have been through them.
Answers that rise to the top
Ask questions, answer, and vote. The most useful interpretation is surfaced by the community, not buried in a thread.
From the basics to the latest
From Annex I requirements to new MDCG guidance and EUDAMED updates — everything in one place through editorial blog articles.
-Classification (Class A–D), Notified Bodies, Performance Evaluation, Technical Documentation, EUDAMED & UDI, Post-Market Surveillance/PMPF, PRRC & Economic Operators, Transition Timelines
Getting Started with IVDR
New to Regulation (EU) 2017/746? Start here — scope, key definitions, the shift from IVDD, and where to find the official texts.
Classification (Class A–D)
Applying the Annex VIII rules. Borderline cases, class determination, and disagreements over where a device lands.
Performance Evaluation & Clinical Evidence
Scientific validity, analytical performance, clinical performance. Performance evaluation plans, reports, and the evidence behind them.
Technical Documentation
Annex II and Annex III. Structure, content, common gaps, and keeping documentation alive over the device lifecycle.
Notified Bodies & Conformity Assessment
Choosing a notified body, application and audit experience, review questions, findings, and certification timelines.
QMS, PRRC & Economic Operators
Article 10 quality management, the Article 15 PRRC role, and the duties of importers, distributors, and authorised representatives.
EUDAMED & UDI
Device registration, UDI assignment and carriers, actor registration, and working with EUDAMED as modules go live.
Post-Market Surveillance & Vigilance
PMS plans and reports, PMPF, PSUR, trend reporting, incidents, and field safety corrective actions.
Transition, Deadlines & Regulatory News
Transitional provisions, extended deadlines, MDCG guidance updates, and changes coming down the line.
Latest discussions
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Compliance gets easier when we share what we learn
Join manufacturers, regulatory and quality professionals, notified body reviewers, and students working through IVDR 2017/746. Ask questions, share your expertise, and help build the reference this community needs.