Legislation for medical devices
Below are links to legislation relevant to the regulation of medical devices.
General
- European Communities (Medical Devices) Regulations 1994 (SI 252/1994)
- European Communities (Medical Devices) (Amendment) Regulations 2001 (SI 444/2001)
- European Communities (Medical Devices) (Amendment) Regulations 2002 (SI 576/2002)
- European Communities (Medical Devices) (Reclassification of Breast Implants) (Amendment) Regulations 2003 (SI 358/2003)
- European Communities (Medical Devices) (Tissues of Animal Origin) Regulations 2003 (SI 554/2003)
- European Communities (Medical Devices) (Reclassification of Hip, Knee and Shoulder Joint Replacements) (Amendment) Regulations 2007 (SI 92/2007)
- European Communities (Medical Devices) (Amendment) Regulations 2009 (SI 110/2009)
- European Union (Medical Devices and In Vitro Diagnostic Medical Devices) Regulations 2017 (SI 547/2017)
- European Communities (Medical Devices) (Amendment) Regulations 2020 (SI 144/2020)
- European Communities (Medical Devices) (Amendment) (No 2) Regulations 2020 (SI 301/2020)
- 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)
IVDs
- European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001 (SI 304/2001)
- European Communities (Medical Devices) (Amendment) Regulations 2002 (SI 576/2002)
- European Communities (In Vitro Diagnostic Medical Devices) (Amendment) Regulations 2012 (SI 207/2012)
- European Union (Medical Devices and In Vitro Diagnostic Medical Devices) Regulations 2017 (SI 547/2017)
- European Communities (In Vitro Diagnostic Medical Devices) (Amendment) Regulations 2020 (SI 145/2020)
- European Communities (In Vitro Diagnostic Medical Devices) (Amendment) (No 2) Regulations 2020 (SI 302/2020)
- In Vitro Diagnostic Medical Devices Regulations 2022 (SI 256/2022)
European Union (National Research Ethics Committees For Performance Studies of In Vitro Diagnostic Medical Devices) Regulations 2022 (SI 257/2022) - In Vitro Diagnostic Medical Devices (Registration) Regulations 2022 (SI 365/2022)
- European Union (National Research Ethics Committees For Performance Studies of In Vitro Diagnostic Medical Devices) (Amendment) Regulations 2023 (SI 670/2023)
- European Union (National Research Ethics Committees For Performance Studies of In Vitro Diagnostic Medical Devices) Regulations 2023 (SI 671/2023)
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)