Module 5 Presentations

16/07/2024

Regulations governing medical devices in EU, US, UK EU MDR stands for European Union Medical Device Regulation which came into effect on 26 May 2021. ■ On 15 March 2023, the European Union extended the EU MDR transition periods for already marketed products . EU IVDR stands for European Union In Vitro Device Regulation which came into effect on 26 May 2022. ■ For already marketed IVD s, the European Commission recently published a proposal to extend transitions timelines US FDA CFR stands for United States: Food and Drug Administration Code of Federal Regulations, Title 21 CFR ■ The FDA regulates medical devices sold in the United States to assure their safety and effectiveness. Further reading on US and EU approval process differences UK Medical Devices Regulations 2002: Currently in Great Britain (GB), medical devices are regulated under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). ■ The UK amended the UK MDR in 2023 to extend time allowed for CE marked devices to be placed on GB market. Further reading on UK regulation of medical devices EU regulations distinguish medical devices and diagnostics and govern them separately. In most other countries, all types of devices are governed under one umbrella of medical devices.

M-GB-00018492 Date of preparation: July 2024

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Regulations and standards governing medical devices

M-GB-00018492 Date of preparation: July 2024

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