| Author (Corporate) | Council of the European Union, European Parliament |
|---|---|
| Series Title | Official Journal of the European Union |
| Series Details | (L) 2024/1860 |
| Publication Date | 09/07/2024 |
| Content Type | Blog & Commentary, Legislation, News, Policy-making |
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. |
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| Source Link | http://data.europa.eu/eli/reg/2024/1860/oj |
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| Subject Categories | Business and Industry, Health, Internal Markets |
| Subject Tags | Medicines | Medical Devices |
| International Organisations | European Union [EU] |
