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# Medicines and Medical Devices Act 2021 – Stakeholder survey launched by MHRA
- URL: https://med-techinsights.com/medicines-and-medical-devices-act-2021-stakeholder-survey-launched-by-mhra/
- Published: 2025-07-21T13:24:14.000Z
- Updated: 2026-10-22T08:33:10.000Z
- Description: Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, an advisor to MedTech suppliers, chair of the Urology Trade Association, and governor of the Anscombe Bioethics Centre, reports on the launch of a stakeholder survey of MedTe
- Author: Oliver Johnson
- Tags: Insights, Policy & Regulation

###### [***Chris Whitehouse***](https://med-techinsights.com/tag/chris-whitehouse/)***, a political consultant and expert on medical technology policy and regulation at*** [***Whitehouse Communications***](http://www.whitehousecomms.com/?ref=med-techinsights.com)***, an advisor to MedTech suppliers, chair of the*** [***Urology Trade Association,***](https://urologytradeassociation.com/?ref=med-techinsights.com) ***and governor of the*** [***Anscombe Bioethics Centre***](https://www.bioethics.org.uk/?ref=med-techinsights.com)***, reports on the launch of a stakeholder survey of MedTech regulations.***

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The [**Medicines and Healthcare products Regulatory Agency**](https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency?ref=med-techinsights.com) (MHRA), in collaboration with the [**Department of Health and Social Care**](https://www.gov.uk/government/organisations/department-of-health-and-social-care?ref=med-techinsights.com) (DHSC), is conducting a review of the UK’s medicines and medical device regulatory framework, and is seeking input from stakeholders across the MedTech sector, including patients and the public.

The review is a statutory obligation under the [Medicines and Medical Devices Act 2021](https://www.legislation.gov.uk/ukpga/2021/3/contents?ref=med-techinsights.com) and is being conducted in accordance with [Part 6, Regulation 48](https://www.legislation.gov.uk/ukpga/2021/3/section/48?ref=med-techinsights.com) 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 governs the development, authorisation, supply, and oversight of medicines and medical devices in the UK. These include:

1. [Human Medicines Regulations 2012](https://www.legislation.gov.uk/uksi/2012/1916/contents?ref=med-techinsights.com) (HMRs): which set out the regime for the manufacture, authorisation, supply, and pharmacovigilance of medicines.
2. [Medical Devices Regulations 2002](https://www.legislation.gov.uk/uksi/2002/618/contents?ref=med-techinsights.com) (MDRs): which provide the regulatory framework for medical devices, including requirements for safety, performance, and conformity assessment.
3. [The Medicines for Human Use (Clinical Trials) Regulations 2004:](https://www.legislation.gov.uk/uksi/2004/1031/contents/made?ref=med-techinsights.com) which govern the conduct of clinical trials of medicinal products.
4. [Medicines](https://www.legislation.gov.uk/uksi/2016/190/contents/made?ref=med-techinsights.com) and [Medical Devices](https://www.legislation.gov.uk/uksi/2002/542?ref=med-techinsights.com) (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.

The MHRA is asking for specific examples, where possible, of cases where change might be appropriate.

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.

A [downloadable version of the survey questions is available here](https://assets.publishing.service.gov.uk/media/687a63095f0f5104b9806bb4/MHRA%5FMMDA%5FSurvey.pdf?ref=med-techinsights.com), and the [online survey is available here](https://www.surveys.mhra.gov.uk/685d2b27b57f79a3d4069b76?ref=med-techinsights.com).

The deadline for completing the questionnaire is **19 September 2025**; and the sector is very much encouraged to engage in this process.

*The Author used AI in preparing this article, comments upon or questions about which can be addressed to* [*chris.whitehouse@whitehousecomms.com*](mailto:chris.whitehouse@whitehousecomms.com).