Introduction
This questionnaire aims to gather data on the costs and benefits of The Medical Devices (Amendment) Regulations 2026 (“the 2026 Regulations”), which are provisions that strengthen safe access to medical devices and in vitro diagnostic (IVD) devices in Great Britain (GB) (England, Scotland, and Wales) as well as enable greater innovation of MedTech. Your participation will help the MHRA understand the impact of the proposed changes. This questionnaire complements the previously run questionnaire to capture inputs for costs and benefits.
Participation in this survey is your opportunity to share the impact these regulations will have on you or your operations. The survey explores the financial implications of all topics covered in the 2026 Regulations, allowing you to highlight any economic challenges that you may encounter. Your inputs will therefore contribute to a more comprehensive understanding of the business impacts of the 2026 Regulations.
This questionnaire will be distributed to various stakeholders. With the appropriate information at hand, it is estimated that the questionnaire will take approximately:
• 45 minutes for Manufacturers
• 20 minutes for Healthcare Organisations
• 20 minutes for Approved Bodies
• 20 minutes for UK Responsible Persons (UKRPs)
• 15 minutes for patients or carers
All respondents should read the guidance document, specifically sections 1 to 7.
This questionnaire will be open from Monday 11th May 2026 to Friday 19th June 2026.