Medicines and Medical Devices Act 2021 – Stakeholder survey
Call for evidence description
About the Review
The Medicines and Healthcare products Regulatory Agency (MHRA), in collaboration with the Department of Health and Social Care (DHSC), is conducting a review of the UK’s medicines and medical device regulatory framework, and we are seeking input from stakeholders across the sector, including patients and the public.
The review is a statutory obligation under the Medicines and Medical Devices Act 2021 and is being conducted in accordance with Part 6, Regulation 48 of the Act, which requires the government to assess the operation and impact of the legislation at least once every five years.
The focus of the review is the legislation that govern the development, authorisation, supply, and oversight of medicines and medical devices in the UK. These include:
- Human Medicines Regulations 2012 (HMRs): which set out the regime for the manufacture, authorisation, supply, and pharmacovigilance of medicines.
- Medical Devices Regulations 2002 (MDRs): which provide the regulatory framework for medical devices, including requirements for safety, performance, and conformity assessment.
- The Medicines for Human Use (Clinical Trials) Regulations 2004: which govern the conduct of clinical trials of medicinal products.
- Medicines and Medical Devices (Fees) Regulations: which outline the fees payable to the MHRA in relation to regulatory services.
The purpose of this review is to evaluate whether the legislation is operating as intended now, if it continues to effectively protect public health, and avoids imposing unnecessary or excessive regulatory burdens. The review is also looking at the structure of the legislation and whether restructure or consolidation would make the regulations clearer or easier to implement.
Our request
We would value your views and experiences on the regulations which are relevant to you or your organisation. Please provide us with specific examples where possible.
The findings from the completed survey will inform the Review and a report to be published by the Secretary of State for Health and Social Care. All feedback will be anonymised in the final report.
The deadline for completing the questionnaire is 19 September 2025.
If you have any questions relating to this review and the completion of the survey, please email: Partnerships@mhra.gov.uk, with “MMD Act Review” in the subject line.
Please download the survey questions below, for reference, before responding to this survey.