June 10, 2021

New FAQ on the European Medical Device Nomenclature (EMDN) to support the EUDAMED

The Medical Device Coordination Group (MDCG), composed of representatives of all Member States and a representative of the European Commission, endorsed a new FAQ on the European Medical Device Nomenclature (EMDN) intended to support the functioning of the European database on medical devices (EUDAMED). Among other things, the EMDN will be utilized by manufacturers to register medical devices in the EUDAMED, where each device will be associated with a Unique Device Identifier – Device Identifier (UDIDI).

As explained in the document, the EMDN primarily serves a regulatory purpose to support the requirements set forth by the medical device regulations (MDR and IVDR); however, it also plays a key role in MDR/IVDR device documentation and technical documentation; sampling of technical documentation conducted by notified bodies; post-market surveillance, oversight, and data analysis; and so on.

The EMDN will be particularly useful for operators once the EUDAMED is operational. The EUDAMED is the IT system developed by the European Commission to implement the MDR and IVDR. It reflects major improvements, as the EUDAMED is a much larger database than the one that currently exists under the Medical Device Directives.

The original plan provided for implementation of the EUDAMED in March 2020, but that date was later postponed by the European Commission. The EUDAMED is composed of six modules; two (the device registration module and the module on certificates and notified bodies) will become available in September 2021 (as announced by the European Commission), while the remaining modules will be available as soon as they are operational. The database is expected to be fully operational in May 2022.

< Back to blog
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
Read more
Our highly-ranked team of professionals will provide newsinsights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

June 9, 2021
The Medical Device Coordination Group endorsed new FAQ on the European Medical Device Nomenclature (EMDN), that aims at supporting the functioning of the European database on medical devices...
May 25, 2021
The Italian Data Protection Authority published guidelines on the role of the Data Protection Officer in public entities: important news for hospitals and healthcare facilities
May 4, 2021
European Health Union: Commission publishes open public consultation on the European Health Data Space
April 22, 2021
Clinical Trial Regulation: Clinical trial EU Portal and Database, essential for the Clinical Trial Information System (CTIS), is now fully functional and on track to go live by 31 January 20...
January 19, 2021
Dematerialization of prescriptions: Ministerial Decree allowing e-prescriptions for drugs not reimbursed by the NHS has been published in the Italian Official Journal.
Search by...
Follow us on
Follow us on