Apr 6, 2021 · Manufacturers of both medical devices and in vitro diagnostic devices need to ensure that they are in compliance with the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) in order to sell their products in the European Union.

Regulation (EU) 2022/112 of the European Parliament and the Council of 25 January 2022 introduced a staggered extension of the transition periods provided for in Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) and deferred the application of conditions for in-house devices.

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.

Infographics; "New Regulations" (IVDR and MDR) (available in all EU languages and Arabic, Chinese, Japanese, Russian: MDR transition periods. IVDR transition periods. Competent authorities in non-EU/EEA countries: The Procurement of MDS and IVDS: Healthcare professionals and health institutions: Manufacturers of medical devices + Step by Step guide

The MDR and IVDR replace the three Directives (90/385/EEC, 93/42/EEC and 98/79/EC) for medical devices. The MDR came into application on 26 May 2021 but provides for a transitional period for certain devices. The IVDR came into application on 26 May 2022 but also provides for a transitional period for certain devices.

Apr 18, 2024 · In the European Union (EU), two significant regulations have been introduced to enhance the safety and effectiveness of medical devices – the In Vitro Diagnostic Regulation (IVDR) and the Medical Device Regulation (MDR).

Jul 4, 2024 · MDCG 2022-8: Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC (May 2022)

Mar 17, 2025 · The EU institutions are continuing with implementation of the MDR and IVDR, with a number of pilot schemes and a particular focus on expert groups to provide harmonized guidance. However, questions still remain about how the framework should operate and companies are facing inconsistent decisions about their products.

Jul 10, 2024 · Regulation (EU) 2024/1860 introduces significant changes to previous regulations on medical devices and in vitro diagnostic medical devices, with the aim of ensuring patient safety, a high level of public health protection and avoiding potential market disruption.

As a result, the European Union Medical Device Regulation (EU MDR) and In-vitro Diagnostic Device Regulation (IVDR) were approved in March 2017 by the European Council and in April 2017 by the European Parliament. MDR entered into enforcement on May 26th, 2020, and IVDR on May 26th, 2022.