IVDR Classification Rules: How to Classify Your IVD Under Annex VIII
IVDR classification rules made practical: the seven Annex VIII rules, implementing rules and MDCG 2020-16 rev.5, with worked examples for Class A to D.
Person Responsible for Regulatory Compliance (PRRC) Under EU MDR and IVDR: Article 15 Qualifications and Duties
Person responsible for regulatory compliance under MDR and IVDR Article 15: qualifications, the micro and small enterprise rule, duties and MDCG 2019-7.
IVDR Performance Evaluation: Scientific Validity, Analytical and Clinical Performance
IVDR performance evaluation explained: Article 56, Annex XIII and MDCG 2022-2 on scientific validity, analytical and clinical performance, PER and PMPF.
PMCF Under EU MDR: Writing the Plan and Evaluation Report Notified Bodies Accept
How to write a PMCF plan under MDR and a PMCF evaluation report that meet Annex XIV Part B, using MDCG 2020-7 and 2020-8, and the mistakes to avoid.
EUDAMED Becomes Mandatory: Which Modules, Which Dates, and What Manufacturers Must Register
EUDAMED mandatory registration began on 28 May 2026 for four modules. See which apply, the November 2026 and May 2027 deadlines, and what to register.
How to Write a Clinical Evaluation Report Under EU MDR
How to write a clinical evaluation report under EU MDR: Article 61, Annex XIV Part A, MEDDEV 2.7/1 rev 4, MDCG 2020-6 and the MDCG 2020-13 template.
Demonstrating Equivalence Under EU MDR: Technical, Biological and Clinical Criteria
Equivalence under EU MDR: the technical, biological and clinical criteria of Annex XIV, MDCG 2020-5, data access under MDCG 2023-7 and Article 61(4)-(6).
IVDR Transition Deadlines Explained: Class D, C, B and A Sterile Dates Under Regulation (EU) 2024/1860
IVDR transition period explained: the 2027–2029 dates by class under Regulation (EU) 2024/1860, the 2025–2027 application deadlines and the conditions.
The Proposed EU MDR and IVDR Revision: What COM(2025) 1023 Would Change for Manufacturers
The MDR revision 2025 proposal, COM(2025) 1023, is not law yet. What it would change for certificates, PRRC, PSURs and vigilance, and how to plan now.