For a number of Medical Device companies, Christmas arrived earlier in 2019.
On the 17th December 2019, the second Corrigendum to the Medical Device Regulations was formally approved.
This has interesting consequences for some Class I devices, that until now would have had to go through the full rigour of the MDR as of the 26th May 2020.
Class I devices that have a valid Declaration of Conformity or Certificate can be placed on the market until the 26th May 2024, without the need of being up-classified immediately.
In summary, if your device:
- Is Class I under the MDD;
- Bears a CE mark (either self-certified or through a Notified Body) on the 26th May 2020;
- Would need a Notified Body if it had to comply to the MDR in full (e.g. due to up-classification or because it is measuring / sterile / surgical and reusable);
then it can be marketed until the 26th of May 2024, provided that, during this period:
- The device does not undergo significant changes in the design or intended purpose;
- MDR requirements for Post Market Surveillance, Market Surveillance, Vigilance, Registration of economic operators and devices are complied with.
The complete text of the corrigendum can be found here – Second Corrigendum to MDR.
Are you a Class I device developer under MDD and want to take an advantage of the up-classification extension? Its time to put together the required documentation to CE mark your Class I device before the 26th of May 2020. Not sure how to do it? The SoftComply eQMS is an affordable and simple solution that can help you in the process!