02/28/2023
Photo by Markus Spiske on Unsplash
The European Union regulates medical devices under the Medical Device Regulation (MDR) (Regulation EU 2017/745) which entered into force May 2017 and into application May 26, 2021 with a three year transition period. The MDR application date was originally planned for May 2020 but was delayed for one year due to the pandemic. The MDR has more extensive requirements than the Medical Device Directive (MDD) (Directive 93/42/EEC) it replaced. This includes the implementation of the medical device database EUDAMED and the requirement for notified bodies to consult with an expert panel before a final decision for the certification is taken on certain high risk devices.
Medical devices in the EU do not follow a premarket authorization. Instead, medium to high risk devices have a conformity assessment procedure with a notified body. Notified bodies are independent, third party conformity assessment groups that are frequently privately held and for-profit. Currently, there are too few notified bodies to keep up with their increased usage under the MDR. This is partly due to more stringent standards per the MDR increasing the length of the designation process and partly due to the pandemic.
On February 16, 2023, the European Parliament voted to adopt the European Commission’ proposal to extend the MDR transition period and to extend some device certificates. To ensure an adequate supply of medical devices, the 20 day waiting period is waived and the amendment is effective when published in the Official Journal of the European Union.
Previously, the European Commission proposed an extension of the MDR transition period for ‘legacy devices’, medical devices that were already covered in the original transition period.
High risk devices (Class III and certain implantable Class IIb) until December 31, 2027, and
Low to medium risk devices (Class IIb devices not included in high risk, Class IIa, Class Im, Is, and Ir) until December 31, 2028.
In the United Kingdom, the EU MDR applies to Northern Ireland. A device with a CE mark can be marketed in Great Britain until June 30, 2023, and there are plans for extending this.
- The Clinical Pathways Team
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