Today, 28 May, the European Commission published two important calls for stakeholders of the medical devices’ sector. The first published initiative is a call for feedback on a draft act concerning joint clinical assessments of medical devices and in vitro diagnostic medical devices. The second initiative is a a call for applications for establishment of EU reference laboratories (EURLs) in public health.
Joint clinical assessments of medical devices
From 28 May until 25 June 2025, stakeholders can share their opinion on a drafted act on join clinical assessment of new health technologies. The Commission implementing regulation would set out rules to ensure that EU-level assessments are conducted in a timely manner and that the relevant experts are involved or consulted.
A registration is necessary to contribute to the public consultation. The Commission provides all information, the draft, and feedback rules.
EU Reference Laboratories for public health
From 28 May until 17 September 2025, laboratories in the EU Member States and EEA countries can apply for a possible designation as EU reference laboratory (EURL) for public health. This year’s call is for laboratories in the area of respiratory viruses.
Some instructions for submitting an application:
- Template for letter of endorsement
- Template for authorisation of coordinator by beneficiary, and Confirmation of joint and several liability for the execution of the tasks
- Template for the Technical Description
For further information on the procedure, laboratories can consult the Guidance document as well as the Commission call.
Do you have questions on compliance of medical devices in the EU, US, UK and Switzerland? Contact us here or at mdlaw@obelis.net.
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