• News announcement
• 13 юли 2022

MDCG 2022-12 - Harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for IVDR)

• News announcement
• 5 юли 2022

Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746

• News announcement
• 13 юни 2022

MDCG 2022-11 - MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements

• News announcement
• 25 май 2022

MDCG 2022-10 - Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746

Benchmarks for high-risk diagnostics

• News announcement
• 21 юни 2022

Setting the scene for EU reference labs for high-risk diagnostics

26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU

• News announcement
• 24 май 2022

Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices

• News announcement
• 26 май 2021

Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices

The UDI Helpdesk helps economic operators in the implementation of the requirements introduced by the new system

Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities

Commission Implementing Regulation (EU) 2020/1207 on common specifications for the reprocessing of single-use devices

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