The UK Responsible Person must understand the legal and regulatory requirements that manufacturers of medical devices must comply with. Following are the key regulatory texts and guidance to be considered.
- The Medical Devices Regulations 2002 (SI 2002 No 618, as amended)
- The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (SI 791)
- The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (SI 1478)
- Regulating medical devices from 1 January 2021
- Register as a manufacturer to sell medical devices from 1 January 2021
- Using the UKCA mark from 1 January 2021