European Union Medical Device Regulation 2017/745 deadline approaches on May 26, 2020. Medical device companies must comply with the new regulations to maintain market access and mitigate risk.
Medical devices and implantable objects have not faced the high level of regulation the public might expect. This is beginning to change. The European Commission has deemed regulations passed in the 1990s insufficient, and with the desire to strengthen legislation for public safety, the new European Union (EU) Medical Device Regulation (MDR) 2017/745 was born. The EU MDR, which takes into consideration technological and scientific progress made in the last 20 years, will increase the amount of data required to put medical devices on the market. This includes items that serve cosmetic purposes, which were previously out of scope.
What is EU MDR?
The EU MDR was first proposed in September 2012, and accompanied by a separate, complementary regulation targeting in-vitro devices. These regulations were developed to increase the safety of medical devices for the general public, as well as improve traceability and legal certainty. Regulators devised the EU MDR because the existing regulation, the EU Medical Device Directive (MDD), was outdated and provided insufficient standards for maintaining safe and properly-functioning medical devices. The regulation entered into force on May 25, 2017, with a transition period for manufacturers that will continue until May 26, 2020.
Currently, there are 500,000 existing, registered medical devices. The majority — 314,000 — will need to be re-certified under the EU MDR in order to maintain market access.
EU MDR NEW RULES HIGHLIGHTS FOR MEDICAL DEVICE MANUFACTURER’S
- Manufacturers will be able to register a device once at the EU level, instead of having to go through multiple registration procedures.
- Clinical trials taking place in more than one EU member state will be subject to a single coordinated assessment instead of multiple national assessments.
- The European database will expand to contain extensive information on medical devices, with most made publicly available.
- Implant cards will include more information for patients
- There will be a financial plan for patient compensation in cases where people have been harmed by medical devices.