Notified Body

Guide to EU Reference Laboratories under IVDR Article 100 for Class D IVDs, including rollout, affected categories, performance verification, batch testing, and manufacturer preparation.

Guide to Implementing Regulation (EU) 2026/977 for MDR and IVDR Notified Body assessments, including QMS rules, maximum timelines, clock stops, quotes, and recertification.

Practical guide to the May 26, 2026 IVDR Class C deadline, covering Notified Body applications, the September 2026 agreement milestone, 2028 market access, and key pitfalls.

Playbook for responding to Notified Body SSCP deficiencies under EU MDR, covering response tables, clinical benefit wording, residual risk, readability, CER/IFU alignment, and EUDAMED readiness.

How to select, evaluate, and change Notified Bodies under EU MDR and IVDR — capacity constraints, selection criteria, transfer process, 2026 implementing regulation, and timeline planning.

Guide to the European Commission MDR and IVDR simplification proposal, including software Rule 11, certificate validity, sandboxes, fees, timelines, and manufacturer impact.

What manufacturers should do after missing the 2024 MDR Notified Body deadlines, including legal status, withdrawal timing, fresh MDR applications, and sell-off rules.

Guide to EU MDR and IVDR transition deadlines for legacy devices, including Articles 120 and 110, class-specific dates, eligibility conditions, EUDAMED, and market access.