The UK Medical Devices Regulations 2002 (UK MDR 2002)
Link to the latest available revised text.
Below you can find details of amending legislation
The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024
UK Statutory Instrument 2024 No. 221 relates to the implementation of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic regulations (EU IVDR) which since 26 May 2022 fully applied in Northern Ireland. It updates existing legislation to ensure that the EU IVDR is fully implemented and can operate effectively in Northern Ireland.
The Medical Devices (Amendment) (Great Britain) Regulations 2023
UK Statutory Instrument 2023 No. 627 amended the 2002 medical device regulations by extending the acceptance of CE marked medical devices on the Great Britain market.
The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023
UK Statutory Instrument 2023 No. 377 amends the legislation setting out the fees charged by the MHRA in relation to the regulation of medical devices (and blood components for transfusion).
Medicines and Medical Devices Act 2021
The Medicines and Medical Devices Act 2021;
- Establishes a Patient Safety Commissioner,
- Introduces powers to enable the existing regulatory frameworks to be updated after the exit from the EU,
- Enables sharing of information with regulators outside of the UK,
- Provides for the establishment of information systems related to medical devices,
- Provides for the establishment of a medical device expert advisory committee,
- Consolidates enforcement provisions for medical devices and introduces civil sanctions.
The Medical Devices (Northern Ireland Protocol) Regulations 2021
UK Statutory Instrument 2021 No. 905 relates to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices1, (EU MDR), which as of 26th May 2021 fully applies in Northern Ireland.
The Medical Devices (Amendment) (EU Exit) Regulations 2021
UK Statutory Instrument 2021 No. 873 was made to ensure that the regulatory landscape for medical devices was fit for purpose after the end of the Implementation Period. Schedule 1 amends the Medical Devices Regulations 2002 (as they apply in Great Britain). Schedule 2 amends certain EU tertiary legislation concerning medical devices.
The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020
UK Statutory Instrument 2020 No. 1478 amended the 2002 medical device regulations by introducing separate rules for Northern Ireland, aligned with the European Economic Area.
UK SI 2020/1478 also amended the (EU Exit) Regulations 2019, adopting the dates of the 2020 Brexit implementation period. It also revoked the transposition of the 2017 EU MDR and EU IVDR provisions from UK’s EU exit legislation. The consequence being, the original medical device directives (AIMDD, MDD and IVDD) would continue to be the applicable regulations in Great Britain after the end of the EU exit transition.
The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
UK Statutory Instrument 2019 No. 1385 was primarily a corrigendum (correcting errors) for the earlier Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.
The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
UK Statutory Instrument 2019 No. 791 anticipated the UK's exit from the EU. Significant changes included introducing a new role of UK Responsible Person (in place of the EU's Authorised Representative) and requiring registration of all devices on the UK market. It also introduced two new parts, to become effective from Brexit day, Part VIII and Part IX (corresponding to the EU MDR and EU IVDR), replacing the original Parts II, III and IV (corresponding to the MDD, AIMDD and IVDD).
The Medical Devices (Amendment) Regulations 2013
UK Statutory Instrument 2013 No. 2327 was an update on the use of animal tissues in medical devices and which allowed the provision of instructions for use for medical devices in electronic form.
The Medical Devices (Amendment) Regulations 2012
UK Statutory Instrument 2012 No. 1426 was an update which added assays for blood screening and diagnosis for variant Creutzfeldt-Jakob disease (vCJD) to List A of Annex II of the IVD regulations.
The Medical Devices (Amendment) Regulations 2008
UK Statutory Instrument 2008 No. 2936 was an update that transposed EC Directive 2007/47 into UK law. Among its many updates, 2007/47 significantly enhanced the requirements for the clinical evaluation.
The Medical Devices (Amendment) Regulations 2007
UK Statutory Instrument 2007 No. 400 was an update which reclassified hip, knee and shoulder joint replacements from Class IIb to Class III medical devices.
The Medical Devices (Amendment) Regulations 2003
UK Statutory Instrument 2003 No. 1697 was an update which reclassified breast implants and introduced new requirements for medical devices manufactured utilising tissues of animal origin.
The Medical Devices Regulations 2002
UK Statutory Instrument 2002 No. 618 established the current UK medical device regulations by transposing the EC Directives of that time into UK law: The Directive on active implantable medical devices (AIMDD), the Directive on general medical devices (MDD) and the Directive on in-vitro diagnostic medical devices (IVDD).
Another important amendment: The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021
Where is the actual legislation requiring the name and address of the UKRP to be on the label when a product is certified under UKCA.
The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019 No. 791) introduced many changes to the primary legislation, the Medical Devices Regulations 2002 (S.I. 2002/618), among them, for example;
– for “CE marking”, each time those words occur, substitute “UK marking”;
– for “his authorised representative”, each time those words occur, substitute “their UK responsible person”.