Legacy Devices in the EU

The Medical Devices Coordination Group (MDCG) issued a guidance document on October 4, 2019 that outlines the validity of certificates issued under the (Active Implantable) Medical Devices Directive (AIMDD), following the Date of Application of the Medical Devices Regulation (EU) 2017/745 (MDR). The “legacy devices” can be placed on the market until the certificate expires or until May 26, 2024, whichever comes first.

However, this means the notified body that issued the original certificate is still responsible for all of the post market surveillance activities that apply to the device and “it has the possibility to take any necessary measure in relation to those.” This also means the member states have to keep monitoring these notified bodies per the MDD/AIMD as well.

Out of the 56 notified bodies that are designated for MDD only 39 of them are moving to MDR designation. If you are a medical device manufacturer that sells product in the EU you may want to communicate with your notified body to determine if you will be able to continue to sell legacy product in the EU after your certificate expires.

Here’s a link to the MDCG guidance document: https://ec.europa.eu/docsroom/documents/37402?locale=en

Let O’Connell & Myers help you ensure that you will be ready for the MDR transition.