On 24 April 2020, the first formal amendment to the EU Medical Device Regulation (MDR) was published in the Official Journal of the European Union. In light of the public health crisis associated with the COVID-19 pandemic, the amendment entered into force on the day of its publication.
With the amendment, the date of application of the EU MDR has been delayed from 26 May 2020 to 26 May 2021. The amendment legally allows for an extra year of conformity review under the MDD and AIMDD.
Furthermore, it entails the following:
- Class I devices with a declaration of conformity drawn up before 26 May 2021, with no notified body involvement under the MDD but with notified body involvement under the MDR, may be placed on the market until 26 May 2024. However, per 26 May 2021, certain MDR procedures shall be in place at the manufacturer, including conduct of (more) stringent post-market surveillance activities.
- Clinical studies that are conducted under the MDD prior to 26 May 2021 may continue to be conducted under the MDD. However, per 26 May 2021, reporting of serious adverse events and device deficiencies shall be aligned with MDR requirements.
- Reusable devices that are required to bear the UDI on the device itself shall have this in place per:
- 26 May 2023, for implantable devices and Class III
- 26 May 2025, for Class IIa and Class IIb
- 26 May 2027, for Class I
It shall be noted that notified bodies will likely not have anticipated this delay. Thus, it is unsure whether there will be capacity available at the notified bodies to continue conformity review under the MDD and AIMDD.
At Avania, we will continue to follow the regulatory impact of the EU MDR in detail.