As is well known, you can write a lot of things on your wish list, but whether the wish will come true in the end is not always in your own hands. Thus, many manufacturers and associations had also wished for an extension of the transition period for medical devices that require certification by a notified body for the first time under the new MDR. The EU now granted them this wish shortly after Christmas and before the deadline expires in May 2020.
The European Council had published a second corrigendum to Medical Device Regulation 2017/745 (MDR), which contained various corrections and amendments. On December 27, 2019, this corrigendum was published in the Official Journal of the European Union and is therefore now legally binding in force.
The EU corrigendum can be roughly divided into three thematic parts, which deal with the following points:
- Data from the pre- and post-market phase of medical devices
- Registration of devices according to both MDD and MDR
- Extension of the transition period for certain class I devices according to MDD
Data from the pre- and post-market phase of medical devices.
A total of four corrections are envisaged in this area. The first amendment concerns the coordinated procedure of clinical trials under Article 78, but this concerns less the manufacturers than the countries involved. The second and last corrections deal with the requirements for the post-market surveillance plan according to Article 84 and Annex III, the third correction deals with the notification of trends according to Article 88 as far as they concern the essential safety and performance requirements from sections 1 and 8 and no longer 1 and 5 as before.
In the requirements for post-market surveillance documentation, the previously somewhat unclear numbering of 1.1 and 1.2 has been replaced by 1 and 2, so that section 1 now refers to the surveillance plan and section 2 to the safety report. This also provides clarity for the reference in Article 79, which has always referred to Section 1.
Registration of devices under both MDD and MDR.
Regarding the registration of devices, there are three points of correction. First, Article120(8) requires manufacturers, authorised representatives, importers and notified bodies to register devices under Article29(4), relevant economic operators under Article 31 and certificates of conformity under Article 56 within 18 months of a currently undefined date. Previously, this transition period only applied to devices and certificates, but now the requirements for devices have been reduced and the registration of the relevant economic operators has been included.
Meanwhile, the notifications to DIMDI according to MDD remain temporarily in place according to the repeal provisions under Article 122; what is new now due to the corrections is only that amended or revoked certificates also remain in place.
Extension of the transitional period for certain class I products according to MDD
Probably the greatest joy now comes from the corrections to Article 120(3) and (4). As a result of the addition, products that previously fell into Class I and will be higher classified under the new MDR or fall under the new Class Ir can be placed on the market until May 2024 and made available or put into service until May 2025. This is provided that the devices continue to comply with Directive 93/42 EEC or 90/385/EEC and do not undergo a significant change under Article 120(3).
Manufacturers should also be aware that this deadline extension does not apply to the market surveillance of the products. All products must be monitored from May 2020 in accordance with the requirements of the MDR and the respective new classification and notifications must be carried out accordingly.
Attention. The corrigendum does not refer to the IVDR 2017/746. Whether there are still changes to the transition periods here as well must continue to be monitored. In any case, you can still add this to your Christmas wish list. In addition, a consolidated version of the MDR with the changes made by the corrigendum is not yet available.
Lastly, we would like to leave you with some good advice for the New Year: Don’t throw your good intentions overboard, also get to work on your Class Ir files. Because despite the EU’s gift of a longer transition period, the work is only Postponed, not Repealed. We will be happy to help you implement your good intentions and support you in revising your clinical data and technical documentation according to MDR requirements.
Please note that all data and listings do not claim to be complete, are without guarantee and are for information purposes only.
