The EU Medical Device Regulation (MDR) 2017/745 came into full effect in May 2021, replacing the previous Medical Device Directive (MDD) 93/42/EEC. This comprehensive regulation introduced significant changes to how medical devices are regulated in the European Union.
What Changed with EU MDR
The EU MDR brought sweeping changes across the entire device lifecycle, with particular focus on:
- Strengthened pre-market requirements and clinical evidence standards
- Enhanced post-market surveillance and vigilance requirements
- Greater transparency through the EUDAMED database
- Stricter requirements for economic operators in the supply chain
Impact on Device Classifications
The EU MDR also introduced changes to device classification rules, with many devices being reclassified to higher risk categories. This has significant implications for the conformity assessment route required for CE marking.
Transition Periods
The regulation includes transition provisions for devices certified under the previous directives, but manufacturers need to be aware of the deadlines and plan their transitions accordingly.
Frequently Asked Questions
What is EU MDR 2017/745 and what did it replace?
EU MDR 2017/745 is the European Union's Medical Device Regulation that came into full effect in May 2021, replacing the previous Medical Device Directive (MDD) 93/42/EEC. It introduced comprehensive reforms across the entire medical device lifecycle, with strengthened pre-market requirements, enhanced post-market surveillance, greater transparency through the EUDAMED database, and stricter requirements for all economic operators in the supply chain including manufacturers, authorized representatives, importers, and distributors.
How did EU MDR change post-market surveillance requirements?
EU MDR substantially enhanced post-market surveillance requirements compared to the MDD. Manufacturers must now plan, establish, document, implement, maintain, and update a proactive PMS system that is an integral part of the quality management system. The regulation requires Periodic Safety Update Reports (PSURs) for Class IIa, IIb, and III devices at defined frequencies, and Post-Market Surveillance Reports (PMSRs) for Class I devices. These must include benefit-risk determinations and conclusions about the continued acceptability of identified risks.
What are the transition provisions for devices previously certified under MDD?
EU MDR includes transition provisions for devices that held CE marking under the previous Medical Device Directive. The specific deadlines depend on the device risk class and were extended by EU Regulation 2023/607. However, these extensions are conditional on manufacturers having lodged a valid MDR application with a notified body by May 26, 2024, and maintaining continuous compliance with the MDD during the transition period. Manufacturers should verify which transition deadline applies to each of their devices and plan accordingly.