MDR (EU) 2017/745 ยท IVDR (EU) 2017/746
Practical guides for medical device and IVD manufacturers preparing for, or maintaining, MDR and IVDR conformity.
The extended MDR transition periods under Regulation (EU) 2023/607: 31 December 2027 and 31 December 2028 deadlines for legacy devices, the conditions that must be met, and what happens if they are missed.
The IVDR transition periods as extended by Regulation (EU) 2024/1860 for Class D, C, B and A sterile legacy IVDs, the QMS and Notified Body milestones, and the new duty to announce supply interruptions.
What MDR technical documentation must contain under Annex II (device description, labelling, design and manufacturing, GSPR, risk management, verification and validation) and Annex III (post-market surveillance).
What post-market surveillance the MDR requires by device class: PMS plan, PMS report for Class I, PSUR frequency for Class IIa, IIb and III, and post-market clinical follow-up under Annex XIV Part B.
How the MDR Unique Device Identification system works: Basic UDI-DI vs UDI-DI vs UDI-PI, issuing entities, UDI carrier deadlines by class and where the Basic UDI-DI must appear.
How MDR Annex VIII Rule 11 classifies medical device software: decision-support software, monitoring software, the Class I fallback, and why most software is Class IIa or higher.