Joint implementation and preparedness plan for Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) has been updated.
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The document underlines that the implementation of the IVDR has proven to be a very challenging task for the whole sector and all concerned: stakeholders, the European Commission and Member States. In order to meet the challenges related to implementation of the IVDR, all actors involved should work closely together.
This paper reassesses the implementation priorities and sets out a joint plan of the Member States and the Commission services, including concrete priority actions in order to have an operational system in place before the date of application (May 26, 2022) and provide key supporting elements as soon as possible.
The main aim of this paper, however, is to agree on where to focus limited resources in the shorter term to ensure delivery as soon as possible and by the date of application.
What are the priorities?
The document divides the priorities into two sets:
- Set A includes actions that are vital for devices to have access to the market (those related to a framework for contingency planning and availability of notified bodies).
- Set B includes legislation and guidance documents that, while not obligatory, would greatly facilitate the work of the actors as well as designation of EU reference laboratories for high-risk IVDs.
How to prepare for the implementation of the IVDR Regulation (EU) 2017/746?
- Perform a precise Gap Analysis.
- Check the new classification rules for IVD devices.
- Check the Technical Documentation.
- Rely on a team of experienced IVD experts to implement the strategies and actions needed to be ready by May 26, 2022.
Meditrial team of medical, regulatory and technical experts will assist you to efficiently bring innovative in vitro diagnostics to market. Contact us today!