Open to all but closing 25 November 2021 - Consultation on the future regulation of medical devices in the United Kingdom

Update: I've now submitted my responses to the Chapter 17 (for members of the public) of the consultation and you can read them here.

*******************************

 This is a wide-ranging consultation on medical devices (which includes big serious medical machines that go 'ping' in hospitals as well as contact lenses and spectacles). Everyone is welcome to give input and there's a chapter (chapter 17) specifically for members of the public (though they're also welcome to comment on any or all chapters too). 

The full thing is here: Consultation on the future regulation of medical devices in the United Kingdom

 

 

 

Chapter 9 is about In vitro Medical Diagnostic Devices, eg lateral flow tests
Chapter 10 is about Software as a Medical Device
Chapter 11 is about Implantable Devices, and so on.

(1) You can read Chapter 17 "Questions for members of the general public" as a web page or download it as a PDF.

(2) You can give your views online here.

The Sections for Chapter 17
Note that Chapter 17 begins at Section 76 (as sections 1 - 75 are in earlier chapters) and ends at Section 83.

There are questions for members of the public associated with Sections 78, 79, 80, 82 and 82. Read the section then answer the questions that follow it, using the 'give your views' link in (2) above.

Section 76 - Introduction
- a bit of scene setting, who's behind this consultation and what does it cover

Section 77 - Background Information on Medical Device Regulation
- how medical devices have been approved so far

Section 78 - Scope and classification
- what's included, and what should be included
• Products without a medical purpose
includes 3 questions (Q78.1, Q78.2 & Q78.3)
• Classification
includes 2 questions (Q78.4 & Q78.5)

Section 79 - Economic operators, registration of medical devices and Unique Device Identification
• Health Institutions (inc 3 questions, Q79.1, Q79.2 & Q79.3)
• Importers and Distributors (inc 2 questions, Q79.4 & Q79.5)
• Unique Device Identification (UDI) (inc 3 questions, Q79.6, Q79.7 & Q79.8)

Section 80 - Clinical investigations and performance studies
• Clinical investigations of medical devices (inc 3 Qns, Q80.1, Q80.2 & Q80.3)
• Summary of Safety and Clinical Performance (SSCP) (inc 3 Qns, Q80.4, Q80.5 & Q80.6)

Section 81 - Approved Bodies and Conformity Assessment
81.1 This section does not contain questions on the above topic in light of its technical nature. To share your thoughts on this topic, see Chapters 5 and 6 of the full consultation.

Section 82 - Post market surveillance, vigilance, and market surveillance
• Vigilance (reporting of incidents) (inc 3 questions, Q82.1, Q82.2 & Q82.3)

Section 83 - Specific products and topics
• Implantable medical devices (inc 3 questions, Q83.1, Q83.2 & Q83.3)
• Routes to market (inc 2 questions, Q83.4 & Q83.5)

The Questions about Chapter 17
The 27 questions are listed below but some contain options to select 'a' or 'b' etc and I've not included those here, please see the web page or PDF linked above. 

Q78.1 Do you think these products should be regulated under the UK medical devices regulations? (Yes/No/No Opinion/Don’t Know)

Q78.2 If you have answered ‘yes’ to question 78.1, which products should be regulated under the UK medical devices regulations (please select all those which apply) [see list in web page or PDF linked above in (1)]

Q78.3 Please provide your reasoning for your answers to questions 78.1-78.2 or any general comments on key considerations for the regulation of products without a medical purpose.

Q78.4 Do you think the classification rules for general medical devices and IVDs should be amended as above? (‘Yes’ / ’No’ / ’Don’t Know/No Opinion’)  

Q78.5 Please provide your reasoning for your answer to question 78.4 or any general comments on the classification of medical devices (including ideas for other ways classification may need to change).

Q79.1 Do you think that health institutions should be required to meet certain requirements for ‘in house’ manufactured devices, such as those laid out above? (‘Yes’ / ’No’ / ’Don’t Know/No Opinion’)

Q79.2 If you have answered ‘yes’ to question 79.1, please choose which requirements should be met by health institutions (select all those which apply from the list below): [see list in web page or PDF linked above in (1)]

Q79.3 Please provide your reasoning for your answers to questions 79.1 and 79.2, or any general comments on the rules that should apply to ‘in house’ manufacturing of medical devices.

Q79.4 Do you think that medical device importers/distributors should meet additional requirements such as those outlined above? (‘Yes’ / ’No’ / ’Don’t Know/No Opinion’)  

Q79.5 Please provide your reasoning for your answer to question 79.4 or any general comments on rules applying to importers/distributors of medical devices in the UK

Q79.6 Do you think manufacturer should be required to assign UDI numbers to medical devices before they enter the UK market? (‘Yes’ / ’No’ / ’Don’t Know/No Opinion’)

Q79.7 What types/classes of medical devices should be included in the requirement for UDI storage (select only one)? [see list in web page or PDF linked above in (1)]

Q79.8 Please provide your reasoning for your answers to questions 79.6-79.7 or any general comments on UDI requirements for medical devices.

Q80.1 Do you think the UK medical devices regulations should include stricter requirements for claiming equivalence? (‘Yes’ / ’No’ / ’Don’t Know/No Opinion’)

Q80.2 If yes, should it be the requirements above or other? [multi-choice options of the above requirements plus other – please specify

Q80.3 Please provide your reasoning for your answers to question 80.1 and 80.2 and/or any general comments on rules that you think should apply to claiming equivalence to another medical device as set out above.
 
Q80.4 Do you think the UK medical devices regulations should introduce the requirement for an SSCP for medical devices? (‘Yes’ / ’No’ / ’Don’t Know/No Opinion’)

Q80.5 What types/classes of medical devices should require a SSCP (select all that apply)? [see list in web page or PDF linked above in (1)]

Q80.6 Please provide your reasoning for your answers to questions 80.4-80.5 and/or any general comments on introducing a requirement for medical devices to have SSCPs.

Q82.1 Do you think manufacturers should be required to consult with patients when investigating device incidents? (‘Yes’ / ’No’ / ’Don’t Know/No Opinion’)

Q82.2 If you have answered ‘yes’ to question 82.1, how do you think manufacturers should consult with patients when investigating incidents (you may want to consider: how the manufacturer would find patients with lived experiences, methods of communication, how the manufacturer would demonstrate that they have taken into account patient views).

Q82.3 Please provide your reasoning for your answers to questions 82.1-82.2 or any general comments on patient and public engagement during incident investigation.

Q83.1 Do you think that the UK medical devices regulations should include the requirements for manufacturers and health institutions to provide patients with implant information? (‘Yes’ / ’No’ / ’Don’t Know/No Opinion’)

Q83.2 If you have answered ‘yes’ to question 83.1, is there any other information which should be included within the implant information? If so, please outline below.

Q83.3 Please provide your reasoning for your answers to questions 83.1-83.2 or any general comments on patient implant information.

Q83.4 Do you think the MHRA should introduce a tailored pathway to market approval for: [see list in web page or PDF linked above in (1)]

Q83.5 Please provide your reasoning for your answers to question 83.4 or any general comments on possible pathways to approval to bring a device to the UK market.