On December 17, 2019, the final vote for the second corrigendum to the Medical Devices Regulation (2017/745, MDR) took place. It is now officially confirmed that some class I medical devices, for example reusable surgical instruments or substance based devices, will be exempt from MDR compliance until 2024.
Experts were right in assuming that the proposed document will be adopted unchanged with a very high probability. One of the most important aspects of the corrigendum certainly is that medical devices classified as class I under the Medical Devices Directive (93/42/EEC, MDD) and up-classified under the MDR, will be exempt from MDR compliance until May 26, 2024. The background for this step apparently is that there are not enough Notified Bodies to issue the certificates that would have been required and that many devices would have been disappeared from the market accordingly.
The most prominent groups of devices that may make use of this exemption are:
- reusable surgical instruments,
- software that would have been up-classified,
- substance-based devices (e.g. lubricants),
What manufacturers should bear in mind
Although this takes some pressure from manufacturers and Notified Bodies, it is very important to not understand this as a delay of the MDR as a whole and consider some important points:
- All class I medical devices that will not need a Notified Body under the MDR as well, may not make use of this exemption.
- Those manufacturers who may and will make use of this exemption, must fulfill the MDR requirements on PMS, vigilance, economic operator registration as of May 26, 2020 whereas the latter point is difficult to implement as long as EUDAMED is not live.
- Those manufacturers who may and will make use of this exemption may not implement any significant changes to their devices as long as they place their products on the market under the MDD. If they do, they are obliged to comply with the new MDR requirements.
- Please note that we expect competent authorities to require certain improvements in the technical documentation for exempt class I products nonetheless. For example, clinical evaluations in accordance with MEDDEV 2.7/1, rev. 4 are generally expected for all medical devices. The same is true for other critical documents. We thus recommend a general review of your documentation until May 26, 2020 in any case.
Final advice on the MDR corrigendum 2
Also, please be advised to not wait too long. Many manufacturers of class Is/m, IIa/b and III devices have extended their certificates until 2024. Although we may expect more Notified Bodies to be designated under the MDR until then, capacity will still be an issue when these manufacturers will apply for MDR designation as well.
Finally, manufacturers should use their time to collect PMCF data on their devices. As mentioned frequently these days, clinical data requirements have grown stricter. Should the MDR corrigendum 2 be accepted as proposed, there will hardly be any excuse for clinical evaluations that do not fulfill the corresponding requirements.
Source: Second MDR corrigendum, Medtech Insight (an Informa product)