As 2024 draws to a close, those drafting official EU medtech documents have had a surge of energy in meeting end of year deadlines and a burst of important and useful EU documents has been published. These include:
From The EU Notified Body Association
Team-NB members have adopted a 16-page position paper describing the pre-application, application and post-application processes through which manufacturers may apply to notified bodies for the certification of their products under the Medical Device Regulation.
The document provides guidance based on TEAM-NB notified body member practices and is relevant for legacy devices being certified under the MDR as well as new devices being certified for the first time.
The paper on the MDR certification process consensus document features an appendix listing data and documents to be submitted by the manufacturer at various phases of the application process.
TEAM-NB points out that it takes between one to three months to conclude the application process (from application to the conclusion of the written agreement) for majority of the applications under MDR.
It is anticipated, the organization says in the paper, that providing a description of the application process with the steps involved in it, identification of the minimum/typical information/data required to be submitted by the manufacturers as part of the application process, will establish a common understanding and minimize the number of incomplete submissions received by the notified bodies. This, it concludes, will help notified bodies process applications more efficiently and in a shorter time frame.
From The Medical Device Coordination Group
The European Commission’s Medical Device Coordination Group (MDCG) has also been busy with two new guidance documents on key topics and two revisions.
The long anticipated guidance on how manufacturers should report the anticipation interruption or discontinuation of supply of devices has been published, alongside a Q&A document and a device identification table.
This is a list of the new and revised guidance documents:
- MDCG 2024-16 Manufacturer Information Form on Interruption or discontinuation of supply of certain medical device and certain IVDs.
- MDCG 2024-15 - Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED.
- MDCG 2022-3 rev.1 - Verification of manufactured class D IVDs by notified bodies.
- MDCG 2019-13 rev 1 Guidance on sampling of devices for the assessment of the technical documentation.
MDCG 2024-15 is a particularly important document as the clinical investigation module of the EU’s medical device database is due to be the last of the six modules to become available; its development is trailing behind the other five modules and not due to be ready until 2027 at the earliest.
From The European Commission - Fact Sheets
The commission’s medical devices unit has published three fact sheets that are intended to inform stakeholders who are not directly at the centre of the EU medtech regulations but whose work is directly impacted by them.
The first is directed at authorities in non-EU/EEA member states, the second for healthcare professionals and health institutions and the third for those involved in the medtech procurement ecosystem.
The links have been added to the commission’s webpage on Getting ready for the new regulations which provides a host of useful essential information for all those with an interest in medtech regulations.
From The European Medicines Agency
The European Medicines Agency, meanwhile, which plays a series of roles related to medical devices, and especially with drug/device combination products and companion diagnostics, has published the first revision of its Guidance on the procedural aspects for the consultation to the EMA by a notified body on companion diagnostics.
This revision, which outlines how EMA should be consulted and provides details on fees and timelines, features a link to a new EMA fees regulation.
