- Devices that are class I devices under Directive 93/42/EEC (MDD) - for which, an EC declaration of conformity was drawn up prior to the 26th of May 2021 and for which the conformity assessment procedure under the MDR requires Notified Body involvement;
- Devices covered by a valid EC certificate issued in accordance with Directive 90/385/EEC (AIMDD) or the MDD prior to 26 May 2021
will continue to be legacy devices under the following conditions:
Until their AIMDD/MDD certificate expires, or until the 26th of May 2024 - whatever comes first; and,
The devices continue to comply with their respective Directives;
There are no significant changes in design and intended purpose;
The manufacturer applies MDR post-market surveillance (PMS) requirements, vigilance, and economic operators and devices registration.
All of the above applies, except that the end date has moved to 31st December 2027 for Class III and Class llb implantable devices (with some exceptions); and, to 31st December 2028 for all other devices.But, this only applies if the manufacturer has lodged a NB application until the 26th of May 2024, and has a NB contract in place no later than 26th September 2024.
So, in order not to loose the legacy device status, a manufacturer needs to comply with all of the above and have a on-going certification process with a NB. Importantly, compliance with MDR PMS is a must from now on, whether it's a legacy device or not.
Don't wait any further, let us help you be compliant!
by Catarina Carrão
(aka Ana Catarina Ribeiro Carrão)