Legislation for medical devices
Below are links to legislation relevant to the regulation of medical devices.
European Regulations
National legislation
- In Vitro Diagnostic Medical Devices Regulations 2022 (SI 256/2022)
- In Vitro Diagnostic Medical Devices (Registration) Regulations 2022 (SI 365/2022)
- European Union (Medical Devices and In Vitro Diagnostic Medical Devices) Regulations 2017 (SI 547/2017)
- European Union (National Research Ethics Committee for Clinical Investigations of Medical Devices) Regulations 2021 (SI 260/2021)
- Medical Devices Regulations 2021 (SI 261/2021)
- Medical Devices (Amendment) Regulations 2021 (SI 510/2021)
- Medical Devices (Registration) Regulations 2021 (SI 691/2021)
Active implantable
- European Communities (Active Implantable Medical Devices) Regulations 1994 (SI 253/1994)
- European Communities (Medical Devices) (Amendment) Regulations 2001 (SI 444/2001)
- European Communities (Active Implantable Medical Devices) (Amendment) Regulations 2009 (SI 109/2009)
- European Communities (Active Implantable Medical Devices) (Amendment) Regulations 2020 (SI 300/2020)