| Author (Corporate) | Council of the European Union, European Parliament |
|---|---|
| Series Title | Official Journal of the European Union |
| Series Details | L 80, Pages 24-29 |
| Publication Date | 20/03/2023 |
| Content Type | Legislation, Policy-making |
Summary:Regulation (EU) 2023/607 - signed by the co-legislators on 15 March 2023 - introducing amendments to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. This is a text with EEA relevance. Further information:Regulation (EU) 2017/745 and Regulation (EU) 2017/746 - also known as MDR and IVDR, respectively - revised the regulatory framework focusing on medical devices and in vitro diagnostic medical devices. They sought to ensure a high level of protection of health for patients and users and the smooth functioning of the internal market for these products. To achieve these objectives and, in light of issues identified with the previous regulatory framework, the Regulations set out a more robust system of conformity assessment to ensure the quality, safety, and performance of devices placed on the EU market. The MDR has been applicable since May 2021 and the IVDR has been applicable since May 2022. The transition period applicable to the first one expires in May 2024, whereas the second one was amended to allow for a staggered extension of its transition period, ranging from May 2025 to May 2028. Despite progress over the past years, the overall capacity of conformity assessment bodies was deemed insufficient to carry out the tasks required of them. In addition, many manufacturers reported its lack of preparation to meet the strengthened requirements of the MDR by the end of the transition period. This posed a threat to the availability of medical devices on the market in the European Union (EU), and negatively impact innovation and business activity in the medical technology sector within the EU. This Regulation extends the existing transition period laid down in the MDR, based on certain conditions. It also deletes the sell-off deadline in the relevant MDR and IVDR provisions. The extension of the transition period is complemented by an extension of the validity of certificates issued under the previous Council Directive 90/385/EEC and Council Directive 93/42/EEC for the devices benefiting from the extended transition period. Also the validity of certificates that have already expired since 26 May 2021 would be extended, subject to certain conditions. The draft law was adopted by the European Commission on 6 January 2023. The plenary of the European Parliament endorsed the draft law on 16 February, followed by the Council of the European Union on 7 March. The Act was signed by the co-legislators on 15 March 2023 and published in the Official Journal on 20 March 2023. |
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| Source Link | http://data.europa.eu/eli/reg/2023/607/oj |
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| Subject Categories | Business and Industry, Health, Internal Markets |
| Subject Tags | Medicines | Medical Devices |
| International Organisations | European Union [EU] |
