Medicines and Medical Devices Act 2021
Medicines and Medical Devices Act 2021

The following Life Sciences practice note provides comprehensive and up to date legal information covering:

  • Medicines and Medical Devices Act 2021
  • Background and purposes of the Medicines and Medical Devices Act 2021
  • Overview of the Medicines and Medical Devices Act 2021
  • Part 1—The Commissioner for Patient Safety
  • Part 2—Human medicines
  • Part 3—Veterinary medicines
  • Part 4—Medical devices
  • Part 5
  • Part 6—Report on operation of medicines and medical devices legislation
  • Part 2—Human medicines
  • More...

This Practice Note provides an overview of the Medicines and Medical Devices Act 2021 (MMDA 2021) which, in summary, makes provision about a Commissioner for Patient Safety in relation to human medicines and medical devices, enables the existing UK regulatory frameworks for medicines and medical devices to be updated following the end of the implementation period, consolidates the enforcement provisions on medical devices and allows the sharing of information on medical devices. The Practice Note outlines the legal context and the purposes of MMDA 2021, tracks the steps of its legislative procedure and examines the key provisions on human medicines, clinical trials and medical devices:

  1. Background and purposes of the Medicines and Medical Devices Act 2021

  2. Overview of the Medicines and Medical Devices Act 2021

  3. Part 2—Human medicines

  4. Part 4—Medical devices

  5. Timeline of legislative procedure

Background and purposes of the Medicines and Medical Devices Act 2021

A large part of the UK legal framework for medicinal products and medical devices originates from EU law (regulations and directives), which has been given effect and implemented in the UK through the European Communities Act 1972 (ECA 1972). ECA 1972 was repealed on exit day by the European Union (Withdrawal) Act 2018 (EU(W)A 2018), however its effect in relation to EU law (as well as to decisions and case law) was preserved during the implementation period.

The UK was still

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