Chapter 16 - Feedback
Updated 26 June 2022
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This publication is available at https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom/outcome/chapter-16-feedback
The consultation sought feedback from respondents on the overall ambition of the changes proposed in its text and whether the changes proposed in the text were proportionate. This section of the consultation also provided a means for respondents to provide any additional information they would like to be considered.
We asked for views on the level of ambition set out in the consultation. This question was answered by 213 respondents, as follows:
- excellent (11%)
- very good (29%)
- good (52%)
- poor (6%)
- very poor (1%)
We also asked if respondents considered the changes to the medical devices regulations proposed in the consultation are proportionate. The question was answered by 214 respondents, as follows:
- yes (67%)
- no (18%)
- don’t known or no opinion (15%)
When asked to provide further information about the answers given to this question, 117 responses were received which provided feedback on the question asked, raising the following common themes:
- global harmonisation of medical devices regulation is a key consideration (51 responses)
- supportive of the proposals outlined in the consultation (23 responses)
- patient safety improvements are very important (8 responses)
- a risk-based approach should be adopted (6 responses)
- difficulty in forming a view until the new regulations are made available (6 responses)
- the regulations need to be proportionate to the size of the UK market (4 responses)
- the burden on manufacturers needs to be considered (4 responses)
Finally, respondents were asked to provide any additional comments or feedback and 114 responses did so. The comment themes in the responses were:
- global harmonisation of medical devices regulation is a key consideration (26 responses)
- views about the formatting of the consultation, both positive and negative (16 responses)
- supportive of the proposals outlined in the consultation (14 responses)
- a risk-based approach should be adopted (8 responses)
- further engagement on some of the proposals should be carried out (5 responses)
- the burden on manufacturers needs to be considered (4 responses)
The issues raised in this section of the consultation are broadly in line with the comments received in the technical chapters or the public chapter (the answers to which have been subsumed into the relevant technical chapter).
We have reviewed all of the comments received and thank everyone who took the time to contribute to this wide-reaching consultation on the future regulation of medical devices.