Consultation outcome

Chapter 14 - Alternative Routes to Market

Updated 26 June 2022

Introducing alternative routes to market could bring a number of benefits, for example in enhancing the supply of devices to the UK market and in supporting the MHRA’s ambition for medical devices regulation to become globally harmonised. Patient safety will remain a priority, and the proposals outlined in the consultation included consideration of how these routes could be introduced with appropriate levels of scrutiny applied to medical devices to ensure they are safe and that they perform as intended.

Section 72 - MDSAP and Domestic Assurance

72.1 Proposals and feedback

The consultation invited views on whether we should introduce an alternative route to market which utilises Medical Device Single Audit Program (MDSAP) certificates. Of the 211 responses received:

• 86% supported the proposal
• 8% did not support the proposal
• 7% did not know or had no opinion

The consultation invited views on whether the MHRA should introduce an alternative route to market which utilises approvals from other countries (Domestic Assurance route). 210 responses were received, of which:

• 84% were in favour of the proposal
• 7% were not in favour
• 9% did not know or had no opinion

The abridged consultation (Chapter 17) invited views on whether the MHRA should introduce a tailored pathway to market approval for manufacturers whose quality management system has been certified under the MDSAP. Of the 67 responses received:

• 78% were in favour of the proposal
• 7% were not in favour
• 15% did not know or had no opinion

The abridged consultation (Chapter 17) also invited views on whether the MHRA should introduce a tailored pathway to market approval for medical devices that have regulatory approval from elsewhere. Of the 66 responses received:

• 74% were in favour of the proposal
• 11% were not in favour
• 15% did not know or had no opinion

Other information provided in comments from respondents to questions in both Chapters 14 and 17 relating to the utilisation of MDSAP and domestic assurance can be summarised as follows:

• the use of MDSAP aligns the UK more closely with international practices
• adopting this approach provides economic and operational benefits to industry
• adoption should not be mandatory
• both routes would allow greater choice for patients
• safety standards must be equivalent to those set out in the UK

72.2 The government response

After careful consideration of responses, it remains the government’s intention to proceed with the proposal to utilise both MDSAP certificates and Domestic Assurance as alternative routes to market in the UK. The MHRA will require UK Approved Bodies to consider MDSAP assessments; however, adoption will be optional for manufacturers. Domestic Assurance routes will allow an abridged assessment with the appropriate scrutiny, and UK Approved Bodies will be able to reject applications under the Domestic Assurance route if they do not consider the evidence provided to be sufficiently robust to undergo assessment via this route.

Section 73 - Pathway for Innovative MedTech

73.1 Proposals and feedback

The consultation invited views on whether the MHRA should introduce a pre-market approvals route to place innovative medical devices into service for a specified time period and for specific use cases. Of the 201 responses received:

• 90% supported the proposal
• 3% did not support the proposal
• 6% did not know or had no opinion

The abridged consultation (Chapter 17) invited views on whether the MHRA should introduce a tailored pathway to market approval for innovative devices. Of the 65 responses received:

• 69% were in favour of the proposal
• 9% were not in favour
• 22% did not know or had no opinion

The consultation asked whether the MHRA should have powers to conduct conformity assessments and issue approvals in certain scenarios, e.g., for use on certain groups of patients and/or within specific healthcare institutions where there is an identified need. Of the 199 responses received:

• 88% supported the proposal
• 9% did not support the proposal
• 3% did not support the proposal

Consultees were invited to provide further information in support of their responses to questions in this section. Key themes can be summarised as follows:

• a flexible approach is required
• this approach would increase choice and treatment options for UK patients
• both SME’s and larger manufacturers should be considered for this pathway
• this approach requires tight regulation to ensure safety
• this pathway makes the UK a more attractive destination for innovators

73.2 The government response

Having considered the views of respondents, the government notes that an innovative MedTech route to market could benefit patients, clinicians, and manufacturers. In light of this, the government intends to proceed with the proposal to establish this route. As outlined in the consultation paper and recognised by respondents both in favour of and opposed to this proposal, a key feature is that the MHRA would hold additional powers to grant initial market approval. The government acknowledges the concerns raised by some respondents that stringent safety measures must be applied. Therefore, this route will be limited to specific, defined, circumstances. Additionally, the MHRA will partner with the National Institute for Health and Care Excellence (NICE) and other key healthcare partners to establish critical end-to-end oversight. Guidance will be published outlining further details.