1. © Safeguarding public health Building a sustainable framework for medical devices regulation Graeme Tunbridge Medicines and Healthcare products Regulatory Agency

2. Slide 2 Date Name Presentation title © Background & context – work on resourcing Presentation at last CAMD meeting – UK volunteered to work with IE Area also being discussed in the context of CAMD-HMA co-operation Work progressed bilaterally by IMB & MHRA – outline set of proposals produced Have focussed on examining whether an EU-wide regime might be set up Recent meetings with industry, Commission & others to discuss

3. Slide 3 Date Name Presentation title © Why is this issue important? Budgets for medical device regulation are under pressure across Europe – heavy reliance on Government funding MHRA seeing a 33% budget reduction for devices work over the next three years A poorly resourced Competent Authority creates issues both pre- and post-market Unable to provide manufacturers and industry with consistency and predictability In a system based on mutual recognition, a single weak Competent Authority can undermine the entire regulatory framework

4. Slide 4 Date Name Presentation title © The current situation Most Member States currently impose some charges on Notified Bodies and industry An increasing number of Member States are looking to expand these charges to cover the cost of regulation As a result, there is significant divergence across Europe, with onerous & confusing requirements for manufacturers Up-front fees on manufacturers – e.g. for clinical investigations and regulatory advice – are likely to hamper innovation So......could a sustainable, consistent, EU-wide funding model be developed between industry and Member States?

5. Slide 5 Date Name Presentation title © A potential fee regime would have two main components Funding for pre-market activity by Competent Authorities related to Notified Bodies (e.g. designation, audit) would continue to be recouped directly from Notified Bodies at a national-level – including any expansion of peer review proposed by the recast Funding for post-market activity by Competent Authorities related to manufacturers (e.g. post-market surveillance, enforcement) would be recouped on the basis of an EU-wide fees regime targeted on manufacturers Funding for pre-market activity by Competent Authorities related to manufacturers (e.g. clinical investigations, regulatory advice) would be covered by the fees regime – to reduce a barrier to market entry, support SMEs and promote innovation

6. Slide 6 Date Name Presentation title © A fee regime on manufacturers would be based on central registration of devices A central registration scheme could operate across the EU, carrying a set fee for all medical devices, based on classification The registration fee could be staggered based on company turnover – meaning lower fees for SMEs – for example: Fee per product would be split in equal portions across Competent Authorities – with potential for enhanced allocation for lead Competent Authority where manufacturer is based to reflect main burden for vigilance activity for a particular product Class IClass IIaClass IIbClass III Small€€€€ Medium€€€ €€€ Large€€ €€€€€€€

7. Slide 7 Date Name Presentation title © The challenges are numerous... Such an approach would need to have broad support from Member States, industry and the Commission An IT solution to enable registration of devices and disbursement of funds would need to be developed A robust process for determining and verifying the size of manufacturers would need to be put into place Clear rules would need to be set out to define roles and responsibilities of different economic operators – avoid ‘gaming’ Could not be done on a voluntary basis – would require legislative change Will need to ensure that fees are directed towards devices regulation, and not used elsewhere

8. Slide 8 Date Name Presentation title ©...but would bring benefits to both Member States and industry Competent Authority activity represents <0.25% of turnover of devices industry across Europe Any fee regime would be minimal cost, bureaucracy-light and designed to support innovation Significant advantages to having a well resourced system – better functioning of the internal market, greater predictability, fewer delays, rapid decision-making A properly resourced vigilance function will help to increase public confidence in the system and guard against a future shift to ‘disaster-driven’ regulation

9. Slide 9 Date Name Presentation title © Next steps Further meetings to discuss outline proposals:  Notified Bodies  industry CEO roundtable  meeting with Commissioner Dalli Further work to consider & refine proposals Next few months are key – time to ‘put up or shut up’

10. Slide 10 Date Name Presentation title © Issues for CAMD Prospects of success – what do CAs think of the direction of travel? Any interest in joining a virtual group to refine the proposals? Any feedback on the substance of proposals, or issues not considered – best directly to me: graeme.tunbridge@mhra.gsi.gov.uk, +44203 080 6554 Finally, thank you for your attention