The UK's EU exit legislation for medical devices and IVDs is "The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019."

Below is a brief summary/commentary, highlighting the main similarities with and differences from the EU's MDR and IVDR.

1. Citation and commencement

Regulation 1. is comparable to EU MDR’s Art. 123 and EU IVDR’s Art. 113, "Entry into force and date of application“.

  • The date stated in the regulation for the “coming into force” is “Exit day” (31 Jan. 2020). Note: “Brexit day” was subsequently amended and replaced with “Implementation period completion day” (31 Dec. 2020).
  • The changes to the registration requirements for legacy MDs, AIMDs and IVDs come into force 4 months after Implementation period completion day.
  • The new UK MD regulations come into force on 26th May 2020.
  • The new UK IVD regulations come into force on 26th May 2022.

2. Interpretation

  • Regulation 2. confirms the basis for the 2019 legislation is the “European Union (Withdrawal) Act” of 2018. Note: The 2018 European Union (Withdrawal) Act was subsequently amended by the “European Union (Withdrawal Agreement) Act” of 2020.
  • Also that the 2019 regulation is not a stand-alone regulation but amends the already existing UK medical devices regulations of 2002. Note: The 2002 regulation was the legislation which transposed the AIMDD, MDD and IVDD into UK law.

3. Amendment of Part 1 of the 2002 Regulations

Regulation 3. amends Part I of the 2002 Regulations. Part 1 is the Introduction and scope.

  • Adds 26 new “Schedules” to the 2002 Regulations. A new schedule on Mutual Recognition Agreements (to support MDSAP) and most of the Annexes of the EU MDR and EU IVDR.
  • Limits the old (AIMDD/MDD/IVDD) Directives applicability to Brexit day.
  • Amends the definitions of “Placing on the market” and “Putting into service” by replacing “Community” market” with the “United Kingdom”.
  • Removes the term “Harmonised Standard” from UK legislation
  • Introduces a new UK specific term of “Designated Standard” for Standards that are accepted by the UK authorities.
  • Revises the definition of “Authorised representative” to being a person/entity outside of the UK, but inside the EEA.
  • uIntroduces a new (UK specific) term “UK Responsible Person” (equivalent of the EU’s Authorised Representative). Not to be confused with “Person Responsible for Regulatory Compliance”.
  • Enables medical devices to comply with the new UK regulations before May 2020 and IVDs before May 2022.
  • Allows for transitional registration arrangements for legacy AIMDD/MDD/IVDD devices until 2025.
  • Allows for transitional arrangements on registration data requirements should the new registration database not be available in time.

4. Amendment of Part II of the 2002 Regulations

Regulation 4. amends Part II of the 2002 Regulations on “general medical devices”. The regulations on general medical devices are the UK’s MDD legislation. 

  • Updates the UK’s registration obligations for legacy (MDD) general medical devices for the duration of the (2020-20205) transition period. They are an transitional step between the limited MDD registration requirements and the full MDR registration requirements to come.
  • Requires the person registering to have a UK address and fulfil many of the Authorised Representatives' obligations found in Article 11 of the EU MDR.

5. Amendment of Part III of the 2002 Regulations

Regulation 5. amends Part III of the 2002 Regulations on “active implantable medical devices”. The regulations on active implantable medical devices are the UK’s AIMDD legislation.

  • Updates the UK’s registration obligations for legacy (AIMDD) active implantable devices for the duration of the (2020-20205) transition period. They are an transitional step between the limited AIMDD registration requirements and the full MDR registration requirements to come.
  • Requires the person registering to have a UK address and fulfil many of the Authorised Representatives obligations found in Article 11 of the EU MDR.

6. Amendment of Part IV of the 2002 Regulations

Regulation 6. amends Part IV of the 2002 Regulations on “in vitro diagnostic medical devices”. The regulations on in vitro diagnostic medical devices are the UK’s IVDD legislation.

  • Updates the UK’s registration obligations for legacy (IVDD) in vitro diagnostic devices for the duration of the (2022-20205) transition period. They are an transitional step between the limited IVDD registration requirements and the full MDR registration requirements to come.
  • Requires the person registering to have a UK address and fulfil many of the Authorised Representatives obligations found in Article 11 of the EU MDR.

7. Amendment of Part V of the 2002 Regulations

Regulation 7. amends Part V of the 2002 Regulations on Notified and Conformity Assessment bodies. Part V is broadly equivalent to EU MDR Chapter IV (Articles 31-46) and EU IVDR Chapter IV (Articles 35-50) on notified bodies.

  • Limits the UK regulations to applying to UK notified bodies only. Not European Community notified bodies as was previously the case.
  • Allows for recognition of Conformity Assessment Bodies from those countries which have a mutual recognition agreement with the UK.

8. Amendment of Part VI of the 2002 Regulations

Regulation 8. amends Part VI of the 2002 Regulations on fees payable.

  • Minor amendments only. Maintaining consistency with changes made elsewhere. For example, on mutual recognition agreements.

9. Amendment of Part VII of the 2002 Regulations

Regulation 9. amends Part VII of the 2002 Regulations on general, enforcement and miscellaneous items.

  • Minor amendments only. Maintaining consistency with changes to wording made in the other amendments. For example, “UK person responsible” in place of “Authorised representative”.
  • Adds “Schedule 2, Mutual Recognition Agreement countries. Currently; Australia, New Zealand, Canada, The United States of America, The Swiss Confederation.

10. New Part VIII of the Medical Devices Regulations

Regulation 10. amends and extends the original 2002 Regulations by introducing a new Part VIII, the medical device regulations.

  • The new Part VIII introduces 68 new regulations (Nos 68 to 135). Essentially equivalent to the EU MDR Articles 1 to 100. Excludes the EU MDR Articles on Notified Bodies and EU specifics such as Articles detailing the role of the EU Commission or requiring collaboration between EU Member States.

11. New Part IX of the Medical Devices Regulations

Regulation 11. amends and extends the original 2002 Regulations by introducing a new Part IX, the in vitro diagnostic medical device regulations.

  • The new Part IX introduces 63 new regulations, Nos 136 to 198. Essentially equivalent to the EU IVDR Articles 1 to 116. Excludes the EU IVDR Articles on Notified Bodies and EU specifics such as those Articles detailing the role of the EU Commission or requiring collaboration between EU Member States.

12. New Schedules to the 2002 Regulations

Regulation 12. amends and extends the 2002 Regulations' original two Schedules by adding 27 new Schedules

  • Schedule 2A modifies the existing Annexes of the AIMDD, MDD and IVDD
  • Schedules 3 to 16. Essentially equivalent to the EUMDR Annexes I to VI, VIII to XI, XIII to XVI. Excludes the two Annexes on Notified Bodies and their certificates and the Correlation table.
  • Schedules 17 to 28. Essentially equivalent to the EUIVDR Annexes I to VI, VIII to XI, XIII to XIV. Excludes the two Annexes on Notified Bodies and their certificates and the Correlation table.