What is the MDR?Medical Devices Regulation (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 will come into force on May 26th, 2021 (following a delay brought about by Covid-19).
Why Are We Moving from MDD to MDR?
- The Medical Devices Directive (93/42/EEC) was in force for all members states of the EU (there are currently 28 including the UK), the members of the European Economic Area (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 and this meant that the directive was open to interpretation by each participating member state and, as such, it was not uniformly implemented across all participating countries.
- Furthermore, the 1993 Directive has not kept pace with the seismic changes in medical technology.
- Regulations are directly applicable in all Member States and do not require transposition into national law.
- The new regulations have been introduced to enforce uniformity and to address the developments in device capability and technology.
- The scandals in Europe involving device manufacturers in recent years have also added to the need for more robust regulation of medical devices.
What Are the Most Important Changes?The new MDR presents a significant development in device regulation. Some of the main changes affecting manufacturers are highlighted below, but 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.
- The issue of liability is much enhanced in the new regulations. EU Authorised Representatives will be held jointly and severally liable for devices.
- The 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