Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices

Author (Corporate) ,
Series Title
Series Details (L) 2024/1860
Publication Date 09/07/2024
Content Type , , ,

Summary:

Regulation (EU) 2024/1860 - adopted by the co-legislators on 13 June 2024 - introducing amendments to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 as regards a gradual roll-out of EUDAMED, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices. This is a text with EEA relevance.

Further information:

Regulation (EU) 2017/745 - also known as the Medical Devices Regulation (MDR) - and Regulation (EU) 2017/746 - also known as the In Vitro Diagnostic Medical Devices Regulations (IVDR) - set a strengthened regulatory framework to ensure a high level of protection of health for patients and users and the smooth functioning of the European Union's (EU) single market for these products. In this context, the Regulations set up a more robust system of conformity assessment to ensure the quality, safety and performance of devices placed on the EU market.

The MDR has applied since May 2021, and the transitional period provided for by Regulation (EU) 2023/607 comes to an end on either December 2027 or December 2028. The IVDR has applied since May 2022. Regulation (EU) 2022/112 introduced a staggered extension of its transitional period ranging from May 2025 to May 2028.

This Regulation further extends the transitional period for certain IVDs to mitigate the risk of shortages of these products, and also enables a gradual roll-out of the electronic systems integrated into the European database on medical devices - also known as EUDAMED - that are finalised, instead of deferring the mandatory of the database until the last of the six modules is completed. The Act also imposes a requirement on manufacturers to give prior notice before interrupting the supply of certain critical medical devices and IVDs.

The draft law was adopted by the European Commission on 23 January 2024. Following informal contacts between the co-legislators, the plenary of the European Parliament adopted a compromise text for this file on 25 April. This was formally endorsed by the Council of the European Union on 30 May. The Act was signed by the co-legislators on 13 June 2024 and published in the Official Journal on 9 July 2024.

Source Link Link to Main Source http://data.europa.eu/eli/reg/2024/1860/oj
Related Links
Official
EUR-LEX: COM(2024)43: Proposal for a Regulation amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=COM:2024:43:FIN
Publications Office of the EU: EU Law Tracker: Proposal for a Regulation amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices https://law-tracker.europa.eu/procedure/2024_21?lang=en
European Parliament: Legislative Observatory: Procedure File for Proposal on Gradual roll-out of Eudamed, information obligation in case of interruption of supply and transitional provisions for certain in vitro diagnostic medical devices (2024/0021(COD)) https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2024/0021(COD)
European Commission: DG Health & Food Safety: Medical Devices https://health.ec.europa.eu/medical-devices-sector_en
European Commission: EUDAMED - European Database on Medical Devices https://ec.europa.eu/tools/eudamed/#/screen/home
European Commission: Press Release, 23/01/2024: Commission proposes measures to improve the availability of in vitro diagnostics https://ec.europa.eu/commission/presscorner/detail/en/ip_24_346
European Commission: Press Release, 25/04/2024: Commission welcomes adoption by European Parliament of measures to improve the availability of in vitro diagnostics https://ec.europa.eu/commission/presscorner/detail/en/ip_24_2291
European Commission: Questions and Answers on in vitro diagnostics and the European Database on Medical Devices (EUDAMED) (23 January 2024) https://ec.europa.eu/commission/presscorner/detail/en/qanda_24_347
Council of the European Union: Press Release, 21/02/2024: Medical devices: Council endorses new measures to help prevent shortages https://www.consilium.europa.eu/en/press/press-releases/2024/02/21/medical-devices-council-endorses-new-measures-to-help-prevent-shortages/
Council of the European Union: Press Release, 30/05/2024: Medical devices: Council adopts new measures to help prevent shortages https://www.consilium.europa.eu/en/press/press-releases/2024/05/30/medical-devices-council-adopts-new-measures-to-help-prevent-shortages/

News
EurActiv, 23/01/2024: Commission proposes extending in vitro diagnostics implementation timeline https://www.euractiv.com/section/health-consumers/news/commissions-proposal-to-extend-in-vitro-diagnostics-implementation-timeline/
Euronews, 24/01/2024: New medical device rules further delayed to avoid shortages https://www.euronews.com/health/2024/01/24/new-medical-device-rules-further-delayed-to-avoid-shortages

Commentary and Analysis
Simmons & Simmons: Publications, 25/01/2024: EC to address the risk of device shortages by amending the MDR/IVDR https://www.simmons-simmons.com/en/publications/clrtd1nkc00bcuk50gnplits7/ec-to-address-the-risk-of-device-shortages-by-amending-the-mdr-ivdr
EurActiv, 26/01/2024: The ongoing saga of the in vitro diagnostics regulation https://www.euractiv.com/section/health-consumers/news/the-ongoing-saga-of-the-in-vitro-diagnostics-regulation/
European Parliamentary Research Service (EPRS): Briefing, 17/07/2024: Medical Devices and In Vitro Medical Devices Regulations: Transitional provisions https://www.europarl.europa.eu/thinktank/en/document/EPRS_BRI(2024)760405

Subject Categories , ,
Subject Tags
International Organisations