Back in May, 2017, the EU Medical Device Regulation (MDR 2017/745) entered into force, replacing existing directives;
- Active Implantable Medical Devices (AIMD)
- In-vitro Diagnostic Directive (IVDD)
- Medical Device Directive (MDD)
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.
About the MDR
The EU Medical Device Regulation applies to all manufacturers selling medical devices within Europe. 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. As a result, the EU legislation framework will become more robust, allowing for greater protection of public health and safety.
Below are some of the improvements made by the MDR:
- A new risk classification system for in vitro diagnostic medical devices in line with international guidance
- Increased transparency and traceability using a comprehensive EU database on medical devices
- Intensified post-market surveillance requirements for manufacturers
- Improved coordination of vigilance and market surveillance between EU countries
During the three-year transition period of the MDR regulation, medical devices can be placed on the market under the current EU Directives as well as the new regulation. This means that CE certificates issued under the current Directives will remain valid for a period of four years post date of issue.
After the transition period, devices placed on the market must conform to the MDR. Please see the below deadline dates:
- Until 25th May 2020, certificates under Medical Device Directive (MDD) are valid
- From 25th May 2020 to 25th May 2024, certificates issued under the MDD, before the MDR fully applies, will be valid for up to 4 years
- Until 25th May 2024, devices in conformity with the MDR can be certified under the MDR and placed on the market
- From 26th May 2024 onward, devices placed on the market must be certified under the MDR