What is the MDR?MDR (EU) 2017/745 repeals the existing medical device directives that were first put in place in 1993. The new regulation was published on May 5th, 2017 and came into force on May 26th, 2021.
Why did we move from MDD to MDR?
- The Medical Devices Directive (93/42/EEC) was in force for all members states of the EU (there are currently 27), the members of the European Economic Area (includes EU countries in addition to Iceland, Lichtenstein and Norway) and two countries with bilateral trade agreements with the EU (Switzerland and Turkey).
- Directives are transposed into national legislation by each Member State meaning that the directive was open to interpretation by each participating member state and subsequently, it was not implemented uniformly across all participating countries.
- Furthermore, the 1993 Directive has not kept pace with the changes in medical technology.
- Regulations are directly applicable in all Member States and do not require transposition into national law.
- The introduction of the new regulations ensure consistency and address developments in both device capability and technology.
- The scandals in Europe involving device manufacturers in recent years have also highlighted the requirement for a more robust regulation of medical devices.
What Are the Most Important Changes?The new MDR represents a significant development in device regulation. Some of the main changes are highlighted below, however this list is not exhaustive.
- Product scope expansion to include products that do not have a medical purpose
- Enhanced roles of economic operators to include manufacturer, authorised representative, distributor and importer.
- Greater emphasis on “liability” – EU Authorised Representatives will be held jointly and severally liable for devices.
- Requirement for manufacturers to appoint a responsible person (RP) who is responsible for compliance with MDR
- More rigorous clinical evidence / clinical evaluation requirements
- Increased focus on post market surveillance
- An overhaul of EUDAMED, the European Electronic Database for Medical Device Information
- Introduction of UDI system – Unique Device Identifiers – to enhance traceability