New guidance on the way on harmonised administrative practices and alternative technical solutions for the exchange of information on medical devices to apply until EUDAMED is launched.
The Medical Device Coordination Group (MDCG) has published a guidance laying down guidelines for harmonised administrative practices and alternative technical solutions until the European database on medical devices (EUDAMED) has been fully developed and is fully functional.
The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission. The MDCG was established by Article 103 of Regulation (EU) 2017/745 on Medical Devices (MDR) and is to provide advice to and assist the Commission and the Member States in ensuring harmonised implementation of the Regulations on Medical Devices
EUDAMED has been delayed
Pursuant to Article 33 of the MDR, the Commission is required to establish the European database on medical devices "EUDAMED". EUDAMED will consist of six different electronic systems (so-called "modules"), which are to facilitate the comparison and processing of data subject to the Regulation. EUDAMED has been delayed, and the launch is not expected to take place until in May 2022. Clear guidelines are therefore required as to the application of certain provisions of the Regulation in the interim period until the final launch of the database.
Main features of the guidance
The guidance aims at drawing up guidelines for the application of certain provisions of the Regulation to be relied upon by the Member States and other relevant parties until the EUDAMED database has been fully developed. The guidance provides suggestions as to how to harmonise administrative practices and alternative technical solutions for the exchange of information.
The solutions suggested aim at the parties as efficiently as possible meeting their obligations laid down in the Regulation. An aim has also been to reduce the risk of imposing additional burdens on the parties. The guidance regulates to a marked degree events where it will be difficult or absolutely impossible for the parties involved to exchange information in the present circumstances.
An important point is, however, that the guidance and its guidelines do not change the general obligations for the parties to comply with the rules of the Regulation. In addition, the reporting requirements pursuant to EUDAMED will apply to all information retrieved and collected by virtue of the Regulation.
The guidance has been drawn up outlining the provisions relating to the application of EUDAMED. Next to each provision, alternative solutions are suggested for providing and/or exchanging information as prescribed by the Regulation. Finally, the parties responsible in each individual case are listed.
It is predominantly positive that EUDAMED guarantees increased and centralised overview of players and medical devices in the EU market. The project is very complex, and the delay has not surprised anyone. The staged launch of EUDAMED is a pragmatic way of starting implementation, and the guidance ensures a hopefully uniform approach across Member States.
Our article on the Danish requirements regarding post-market surveillance of medical devices describes some of the consequences the delay of EUDAMED has in a Danish context.