The European Union Medical Device Regulation 2017/745, or MDR, is a significant development and strengthening of the existing regulatory system for medical devices in Europe.
Enforceable in All Member States
The legislation in the form of a Regulation, rather than a Directive, means that the EU law is directly enforceable in all member states without requiring transposition by each member state into national law.
This will allow for greater legal certainty and prevents variation in the approach taken or in the rules relating to medical devices that are applied across EU Member States.
All Manufacturers Selling Medical Devices Within Europe
The EU Medical Device Regulation applies to all manufacturers selling medical devices within Europe which means that companies which place medical device products on the European Market have legal obligations.
The MDR will require further inspection of technical documentation, place rigorous requirements on clinical evaluation and will also increase traceability of devices through the supply chain.
The MDR entered into force back in May 2017, replacing the following existing directives:
- Active Implantable Medical Devices (AIMD)
- In-vitro Diagnostic Directive (IVDD)
- Medical Device Directive (MDD)
3-Year Transition Period
By 26th May 2020, the new regulation will have completed its 3-year transition period, by which all manufacturers should have updated their technical documentation and processes.
One-Year Delay
However, on April 3rd, 2020 the European Commission proposed a one-year delay of the Medical Devices Regulation (MDR) to the European Parliament and Council due to the Covid-19 pandemic.
Originally the Date of Application (DoA) was set on May 26th, 2020, but would move to May 26th, 2021 according to the EC proposal.
This initiative should be viewed as a welcome improvement in the EU regulatory system for medical devices.
Robust Regulatory Framework
It will allow for an effective, consistent and robust regulatory framework for medical devices across Europe allowing for greater protection of public health and safety.
Above all, this regulation puts patient safety first.