2017/746 - EN - Medical Device Regulation - EUR-Lex
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance.
In Vitro Diagnostic Regulation (IVDR)—Frequently Asked Questions
On May 26, 2022, the IVDR becomes effective, meaning after that date any new IVD devices placed on the market must be CE marked according to IVDR. A recent amendment by the commission to the implementation of the IVDR allows some existing products (excluding Class A non-sterile devices) to continue to be placed on the market in compliance with ...
This guideline describes the information that should be presented in the Quality part of a marketing authorisation dossier for a medicinal product when it is used with a medical device, or device part, and submitted in accordance with Directive …
This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules as set out under Annex VIII.
Medical Devices - In Vitro Diagnostics - European Commission
Feb 22, 2024 · The European Commission may designate EU reference laboratories (EURLs) for high-risk in vitro diagnostic medical devices (IVDs)...
Demystifying CE-IVD – what is it and what does it mean for me?
Dec 21, 2021 · CE-IVD certification under the IVDD is an important preliminary step in the journey to becoming a CE-marked clinical diagnostics tool under the upcoming and legally binding In-Vitro Diagnostics Regulation (IVDR).
The New EU Regulation on In Vitro Diagnostic Medical Devices ...
Apr 21, 2021 · The IVDR primarily regulates CE-IVDs, but also addresses IH-IVDs that are manufactured and used by health institutions (referring to reagents, control materials, software, etc; see also Box 1).
IVDR stands for ‘In Vitro Diagnostic Regulation’. This is a European regulation that comes into effect 26th May 2022 and sets out requirements for in vitro diagnostic (IVD) medical devices. Manufacturers need to comply with the regulation in order to apply a ‘CE’ mark and place IVD medical devices on the EU market after May 2022.
Manufacturer IVD - European Commission - Public Health
Manufacturer IVD. As under the current regulatory regime, manufacturers of in vitro diagnostic medical devices take prime responsibility for getting their products CE-marked for the European market. Now, they need to manage the change to get …
While the European Commission recently proposed to adapt the full IVDR mandatory application dates depending on the class of medical device, organizations that are not already working with a Notified Body (NB) on CE mark submission may have a tough few years ahead.