Are you ready for the new European Medical Devices Regulation?
The new European Medical Devices Regulation (MDR) came into force on May 25th to replace the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC).
New regulations often cause a widespread feeling of panic, but in fact companies have a transitional period of three years to update their technical documentation and processes to meet the requirements of the new MDR.
At IDC, we are advising manufacturers to recognise two things at present: that the new MDR is now published, which means it's concrete and should be acted on; and we are urging companies to make a plan and start acting on it to create a programme of change, as there is a lot to do in a relatively short time frame. By planning early, the transition should be smooth.
The existing regulatory framework dates back to the 1990s and consists of three Directives. However, problems with divergences in the interpretation and application of the rules, technological progress as well as incidents involving malfunctions of medical devices - for example the PIP breast implant scandal - highlighted the need for revision of current legislation.
The new MDR requires greater scrutiny of technical documentation. Following concerns over the assessment of product safety, there are now stricter demands for clinical evaluation and post-market clinical follow-up with better traceability of devices through the supply chain. These new rules are designed to reflect the fact that all medical and in vitro diagnostic devices should include the latest scientific and technological innovation. The rules will also provide more transparency and legal certainty for producers, manufacturers and importers and help to strengthen international competitiveness and innovation in this strategic sector.
The new MDR in a nutshell:
- stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level
- the reinforcement of the criteria for designation and processes for oversight of Notified Bodies
- the inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices under the scope of these regulations
- the introduction of a new risk classification system for in vitro diagnostic medical devices in line with international guidance
- improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification
- the introduction of an ‘implant card’ containing information about implanted medical devices for a patient
- the reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorisation of multi-centre clinical investigations
- the strengthening of post-market surveillance requirements for manufacturers
- improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance.
Reference:
- New EU rules on medical devices to enhance patient safety and modernise public health http://ec.europa.eu/growth/tools-databases/newsroom/cf/itemdetail.cfm?item_id=9119&lang=en
- Revisions of Medical Device Directives http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision_en
