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Guidance on harmonised administrative practices & alternative technical solutions in the absence of Eudamed
The Medical Device Coordination Group (MDCG) endorsed MDCG 2022-12 guidance to Member States and other relevant parties on the application of certain provisions of the In Vitro Diagnostic Medical Devices Regulation (IVDR) during the absence of Eudamed. To that end, the guidance intends to describe harmonised administrative practices and alternative technical solutions for the exchange of information until Eudamed becomes fully functional.
Find out more here.
EC publishes summary on coverage of designation codes for notified bodies
The European Commission has published a summary on coverage of designation codes for notified bodies designated under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). According to the summary, as of 15 July 2022, over 80% of codes were covered by more than 20 out of 31 notified bodies for the MDR and by the seven notified bodies for the IVDR.
Read more here.
In vitro diagnostics section on the European Commission website
A section on in vitro diagnostics is now available on the European Commission website under Public Health. The new section contains information on transitional provisions, common specifications, the IVD expert panels, EU reference laboratories and guidance documents endorsed by the Medical Device Coordination Group (MDCG).
For more, see here.
MDCG guidance on designation, re-assessment
and notification of conformity assessment bodies and notified bodies
The Medical Device Coordination Group (MDCG) endorsed MDCG 2022-13 guidance for the authorities responsible for notified bodies and joint assessment teams when conducting assessments of conformity assessment bodies that apply for designation as a notified body in the field of medical devices and/or in vitro diagnostic medical devices, and for re-assessments of notified bodies.
For more, see here. |
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