Regulation (EU) 2022/112 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices

Summary:

Regulation (EU) 2022/112 - formally signed by the co-legislators on 25 January 2022 - introducing amendments to Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices. This is a text with EEA relevance.

Further information:

Regulation (EU) 2017/746 - also known as the In Vitro Diagnostic Medical Devices Regulation - updated rules on placing on the EU market, making available and putting into service in vitro diagnostic (IVD) medical devices for human use and their accessories. It also contains rules on the conduct of performance studies carried out in the European Union concerning IVD medical devices (or accessories).

This draft law proposed a progressive roll-out of the Regulation to prevent disruption in the supply of these healthcare products. The challenges posed by the COVID-19 (coronavirus) pandemic diverted resources from Member States, health institutions and economic operators towards addressing the crisis, thereby hampering the capacity to comply on time with the changes introduced. It did not change requirements in substance but changed the transitional provisions to allow the Regulation's progressive rollout.

The proposal was tabled by the European Commission on 14 October 2021. The draft Regulation was adopted by the European Parliament on 15 December, followed by the Council of the European Union on 20 December. The Act was signed by the co-legislators on 25 January 2022, and published in the Official Journal on 28 January 2022. The rules became applicable on 26 May 2022.

• Primary Source

Commentary and Analysis

Van Bael & Bellis: Insights & News, 31/01/2022: Regulation on In Vitro Diagnostic Medical Devices - Transitional Provisions and Deferred Application https://www.vbb.com/insights/corporate-commercial-regulatory/regulation-on-in-vitro-diagnostic-medical-devices-transitional-provisions-and-deferred-application

Siemens Healthineers: Laboratory Diagnostics: New In-Vitro Diagnostics Regulation is a challenge and opportunity https://www.siemens-healthineers.com/laboratory-diagnostics/ivdr

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Official

EUR-LEX: COM(2021)627: Proposal for a Regulation amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=COM:2021:627:FIN

European Parliament: Legislative Observatory: Procedure File for Proposal on Transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices (2021/0323(COD)) https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2021/0323(COD)

European Commission: Public Health: Medical Devices https://ec.europa.eu/health/md_sector/overview_en

European Commission: Press Release, 14/10/2021: Public health: Commission proposes a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation https://ec.europa.eu/commission/presscorner/detail/en/ip_21_5209

European Commission: Questions and Answers on the progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation (14 October 2021) https://ec.europa.eu/commission/presscorner/detail/en/qanda_21_5210

European Commission: Press Release, 20/12/2021: Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation https://ec.europa.eu/commission/presscorner/detail/en/IP_21_6965

European Commission: Press Release, 25/05/2022: Public health: Stronger rules for placing medical tests on the market https://ec.europa.eu/commission/presscorner/detail/en/ip_22_3288

European Commission: Questions and Answers: Stronger rules for placing medical tests on the market (25 May 2022) https://ec.europa.eu/commission/presscorner/detail/en/qanda_22_3289

UK Research & Innovation (UKRI): Medical Research Council: Developing healthcare products https://www.ukri.org/councils/mrc/facilities-and-resources/find-an-mrc-facility-or-resource/mrc-regulatory-support-centre/developing-healthcare-products/medical-devices-and-in-vitro-diagnostics/

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