There has been growing concern among many manufacturers about how the new Medical Device Regulation (MDR) will affect currently marketed devices, also known as “legacy devices”.
The incoming MDR, due to take effect in May 2020, will include classification changes for some medical devices, along with extended requirements for technical documentation and clinical data.
The European Commission’s (EC) Medical Device Co-ordination Group (MDCG) has, in a recent guidance document, clarified some issues on the validity of certificates issued under the old Medical Devices Directive (MDD), after May 2020. These legacy devices can be placed on the market under specific conditions outlined in the guidance, until their certificate expires or May 2024, whichever comes first.
The Notified Body (NB) which issued the certificate under the MDD, must remain designated as long as it maintains its surveillance activities. Therefore, the device manufacturer must have an agreement with their NB to ensure continuing surveillance, as long as the NB is willing to continue their activities under the new MDR.
However, there are some issues which have not been addressed in this guidance. Firstly, there is uncertainty over whether the MDD agreements with Turkey and Switzerland will remain in place. This means uncertain times for manufacturers using one of the seven NB’s based in these countries. Secondly, only 39 of the 56 NBs designated for the MDD, are seeking designation under the MDR. Therefore, future certification capabilities of 17 NBs are unclear, although it is likely that NB’s designated under MDR will remain active for the MDD as well.
Unless manufacturers have already certified their legacy devices under the MDR, it is recommended that they communicate effectively with their current NB to prepare their legacy files for an early transition to the MDR.
To access the full guidance, click here.