QARA regulatory intelligence
In-depth analyses, practical guides and news on medical device regulation. For demanding QA/RA professionals.
The AI Act and medical devices: the new timeline after the digital omnibus
The digital omnibus (Regulation (EU) 2026/1744) pushes high-risk AI Act obligations for medical device AI to 2 August 2028. What already applies.
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Medical device classification: the 22 MDR rules
Classes I, IIa, IIb and III: the 22 rules of MDR Annex VIII, the implementing rules, special cases and what the class changes for CE marking.
Medical device cybersecurity: MDR, MDCG and FDA requirements
Cybersecurity requirements for medical devices: MDR Annex I, MDCG 2019-16, IEC 81001-5-1, NIS 2 and FDA section 524B (SBOM, vulnerability management).
MDR technical documentation: what Annexes II and III require
What a medical device's technical documentation must contain under MDR Annexes II and III: description, design, GSPR, risk, V&V and post-market surveillance.
FDA QMSR: what changed with ISO 13485 in February 2026
Since 2 February 2026, the QMSR (21 CFR 820) incorporates ISO 13485:2016 by reference. FDA-specific requirements, inspections and records now open to review.
ISO 14971: medical device risk management explained
ISO 14971:2019 step by step: plan, risk analysis, evaluation and control, overall residual risk, review, production and post-production, and the MDR link.
CE marking of a medical device: the steps under the MDR
How to CE mark a medical device under the MDR: qualification, class, quality system, technical documentation, notified body, EU declaration, EUDAMED.
MDSAP: the medical device single audit program explained
MDSAP: one quality system audit recognised by the United States, Canada, Brazil, Australia and Japan. Audit cycle, nonconformity grading and limits.
MDR and IVDR harmonised standards: presumption of conformity and monitoring
Harmonised standards under the MDR and IVDR: Official Journal publication, presumption of conformity, revisions and common specifications.
Post-market surveillance: PMS, PSUR and PMCF under the MDR
MDR Articles 83 to 86 and Annex III: post-market surveillance system and plan, PMS report, PSUR by class, PMCF, trend reporting and vigilance.
Medical device regulatory monitoring: the complete method
How a medical device manufacturer should organise regulatory monitoring: sources to follow, frequency, log, impact analysis and proof for audits.
IVDR deadlines 2027-2029: the IVD transition calendar
IVDR and Regulation (EU) 2024/1860: class D by 31/12/2027, C by 31/12/2028, B and sterile A by 31/12/2029. Conditions to meet and action plan.
Materiovigilance in hospitals: the role of the biomedical engineer and the local vigilance officer
Role of the local materiovigilance officer and the biomedical engineer: hospital obligations, what to do when an FSCA hits your fleet, fleet monitoring.
Proof of regulatory monitoring in an ISO 13485 audit: how to document it
Which sources to monitor, how often, and how to prove your regulatory monitoring in an ISO 13485 audit or to your notified body (MDR Article 10(9)).
Understanding the MDR 2017/745 regulation in 2026
Regulation (EU) 2017/745 in plain terms: scope, classes, PRRC, Annex I, technical documentation, clinical evaluation, PMS and 2027-2028 transition deadlines.
EUDAMED in 2026: a practical guide for manufacturers and authorised representatives
EUDAMED has been mandatory since 28 May 2026 for four modules: SRN, device registration, certificates, update deadlines and mistakes to avoid.
MDR clinical evaluation: what Article 61 really requires
MDR Article 61 and Annex XIV: sufficient clinical data, equivalence, mandatory investigations, CER, PMCF, SSCP and MDCG 2020-5 to 2020-8 guidance.
QARA glossary: 60 essential acronyms explained
MDR, IVDR, PRRC, EUDAMED, UDI, CER, PMCF, PSUR, MDSAP, QMSR: the 60 acronyms of medical device regulatory affairs and quality assurance.
Software as a medical device: MDR Rule 11 explained
MDR Rule 11 and MDCG 2019-11: when software is a medical device, how to classify it as class I, IIa, IIb or III, with examples and standards.
MDR vs IVDR: the essential differences to know
MDR (2017/745) or IVDR (2017/746)? Scope, classes I-III and A-D, clinical or performance evaluation, notified bodies, PMS and transition deadlines.
How to prepare for an ISO 13485 audit in 2026
ISO 13485 audit: timeline from 6 months before to 90 days after, evidence to gather, typical questions by clause and how to answer nonconformities.
PRRC: who can be one and what are their responsibilities?
Who can be a PRRC under Article 15 of the MDR and IVDR: degree or 4 years' experience, five duties, external PRRC for SMEs, EUDAMED and penalties.
UDI and EUDAMED: concrete obligations for manufacturers in 2026
UDI-DI, UDI-PI, Basic UDI-DI, labelling deadlines by class and the EUDAMED modules mandatory since 28 May 2026: what manufacturers must do.
Materiovigilance and the MDR vigilance system: complete 2026 guide
Vigilance under the MDR (Articles 87 to 92): serious incident definition, 2, 10 and 15-day deadlines, FSCA, trend reports, PSUR and competent authorities.
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