QARA regulatory intelligence
In-depth analyses, practical guides and news on medical device regulation. For demanding QA/RA professionals.
IVDR deadlines 2027-2029: the IVD transition calendar
Complete IVDR transition calendar (Regulations EU 2017/746 and 2024/1860): cut-off dates by class D, C, B and sterile A, extension conditions and an action plan for in vitro diagnostic device manufacturers.
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UDI and EUDAMED: concrete obligations for manufacturers in 2026
A practical guide to Unique Device Identification (UDI) and EUDAMED obligations for medical device manufacturers. Deadlines, modules, registration and penalties.
MDR clinical evaluation: what Article 61 really requires
A complete breakdown of Article 61 of the MDR 2017/745: clinical equivalence, existing data, clinical investigations and the clinical evaluation report. A practical guide for QA/RA professionals.
Materiovigilance and the MDR vigilance system: complete 2026 guide
Everything you need to know about MDR 2017/745 vigilance obligations: serious incident reporting, FSCA, trend reports, PSUR and the role of ANSM. A practical guide for QA/RA teams.
Materiovigilance in hospitals: the role of the biomedical engineer and the local vigilance officer
How the hospital biomedical engineer and the local materiovigilance officer (CLMV) handle recalls, FSCAs and ANSM alerts across the medical device fleet. Obligations, reporting circuit and best practices.
Proof of regulatory monitoring in an ISO 13485 audit: how to document it
In ISO 13485 audits and notified body reviews, the traceability of regulatory monitoring is systematically questioned. Which sources, how often, with what evidence? A practical guide to documenting your MDR/IVDR watch.
Understanding the MDR 2017/745 regulation in 2026
A complete, up-to-date guide to the European MDR 2017/745 regulation: scope, device classification, essential requirements, CE marking, post-market surveillance. The reference manual for QA/RA professionals.
EUDAMED in 2026: a practical guide for manufacturers and authorised representatives
Everything you need to register, declare and use EUDAMED in 2026: available modules, obligation calendar, UDI, SRN, vigilance reports. The operational guide for QA/RA professionals.
QARA glossary: 60 essential acronyms explained
The reference glossary of acronyms in medical device regulatory affairs and quality assurance. MDR, IVDR, ANSM, FDA, PRRC, EUDAMED, MDSAP, UDI, CER, PMCF — all definitions made clear.
Software as a medical device: MDR Rule 11 explained
Understanding Rule 11 of the MDR 2017/745 which classifies software as a medical device. Scope, classes IIa to III, concrete examples, points of attention for developers and QA/RA professionals.
MDR vs IVDR: the essential differences to know
A structured comparison of the MDR 2017/745 (medical devices) and the IVDR 2017/746 (in vitro diagnostic devices). Scope, classification, clinical requirements, surveillance — everything that separates the two frameworks.
How to prepare for an ISO 13485 audit in 2026
A complete guide to preparing for an ISO 13485:2016 certification or surveillance audit: documentary checklist, points of attention by chapter, behaviours to adopt, classic mistakes. For medical device quality managers.
PRRC: who can be one and what are their responsibilities?
A complete guide to the Person Responsible for Regulatory Compliance (PRRC) under the MDR 2017/745 and IVDR 2017/746: qualifications, duties, legal status, outsourcing, penalties.
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