skip to main content
Newsroom
Overview   News
eHealth : Digital health and care

Presentation and recording - EUHPP Live Webinar on European Health Data Space (1/3): Primary Use of health data and Electronic Health Record Systems (18 February 2025)

 
EU Health Policy

REMINDER - EUHPP Live Webinar: Union prevention, preparedness and response plan (28 February 2025, 10:00 - 11:30 CET)

 
New legislative initiatives in support of the MDR and IVDR

New legislative initiatives in support of the MDR and IVDR

In December 2024, on the ‘Have your say’ portal, the Commission published information on new legislative initiatives (implementing and delegated acts) in support of Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) as indicated below.

These initiatives are planned to be adopted during 2025.

 
European Medical Device Nomenclature (EMDN): revisions and training sessions

European Medical Device Nomenclature (EMDN): revisions and training sessions

In January 2025, the first revision of the European Medical Device Nomenclature (EMDN)was made available after a broad consultation process that included stakeholders from around the world. The 2025 cycle of public consultation has been launched via the EMDN submission platform, open to all interested to provide their input to the annual revision.

In November 2024, the EU hosted a training session on the EMDN. The training materials from this event are available here. Further sessions will take place to ensure that all interested parties can benefit from the work.

 
Dashboard update for the ‘Study supporting the monitoring of availability of medical devices on the EU market’

Dashboard update for the ‘Study supporting the monitoring of availability of medical devices on the EU market’

In November 2024, the dashboard of the ‘Study supporting the monitoring of the availability of medical devices on the EU market’ was updated.

For more, see the Commission’s web page on the Study supporting the monitoring of availability of medical devices on the EU market.

 
Survey on the status of the implementation of the MDR and IVDR

Survey on the status of the implementation of the MDR and IVDR

In December 2024, the second survey round for economic operators dealing with medical devices and in vitro diagnostic medical devices within the ‘Study supporting the monitoring of availability of medical devices on the EU market’ was launched.

The survey, specifically addressed to medical device (MD) and in vitro diagnostic medical device (IVD) manufacturers, authorised representatives, importers and distributors, is open until 28 February 2025.

For more, see the Commission’s web page on the Study supporting the monitoring of availability of medical devices on the EU market.

 
Public consultation and call for evidence for the targeted evaluation of the EU Regulations on medical devices

Public consultation and call for evidence for the targeted evaluation of the EU Regulations on medical devices

In December 2024, the European Commission launched a public consultation with an EUSurvey questionnaireand a call for evidence on the EU legislation on medical devices (Regulation (EU) 2017/745, MDR) and in vitro diagnostic medical devices (Regulation (EU) 2017/746, IVDR), as part of the targeted evaluation of these rules.

The consultation and call for evidence are open until 21 March 2025.

For more, see the Commission’s ‘Have your say’ page on EU rules on medical devices and in vitro diagnostics – targeted evaluation.