The Medicines and Healthcare products Regulatory Agency (MHRA) has published a questionnaire to gather feedback on the anticipated impacts of the Medical Devices (Amendment) Regulations 2026.
The questionnaire is intended to collect information on the costs and benefits associated with the proposed regulations, which aim to strengthen safe access to medical devices and in vitro diagnostic (IVD) devices across Great Britain (England, Scotland, and Wales) while supporting innovation within the MedTech sector. Feedback received will help the MHRA better understand the practical and economic effects of the proposed regulatory changes.
Participation provides stakeholders with an opportunity to share how the 2026 Regulations may affect their organisation, operations, or activities. The survey focuses on the financial implications of the various measures introduced by the regulations and allows respondents to identify any economic challenges or compliance burdens they may face. The information gathered will contribute to a more comprehensive assessment of the business impact of the proposed framework.
The questionnaire has been distributed to a wide range of stakeholders, including manufacturers, healthcare organisations, approved bodies, UK Responsible Persons (UKRPs), and patients or carers. The MHRA estimates that completion times will vary depending on the respondent type:
- Manufacturers: approximately 45 minutes
- Healthcare Organisations: approximately 20 minutes
- Approved Bodies: approximately 20 minutes
- UK Responsible Persons (UKRPs): approximately 20 minutes
- Patients or Carers: approximately 15 minutes
All participants are advised to review the introductory guidance, particularly Sections 1 to 7, before completing the questionnaire. Additional guidance tailored to specific respondent groups is provided later in the document.
The questionnaire is open for responses from 11 May 2026 until 19 June 2026. Stakeholders are encouraged to participate to ensure their perspectives are considered as the MHRA evaluates the potential impact of the proposed regulations.
The questionnaire can be accessed using the following link
