©

Safeguarding public health

Building a sustainable framework for medical devices regulation

Graeme Tunbridge

Medicines and Healthcare products Regulatory Agency

Slide 2DateName

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

Slide 3DateName

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

Slide 4DateName

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?

Slide 5DateName

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

Slide 6DateName

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 I Class IIa Class IIb Class III

Small € € €€ €€

Medium € €€ €€ €€€

Large €€ €€ €€€ €€€€

Slide 7DateName

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

Slide 8DateName

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

Slide 9DateName

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’

Slide 10DateName

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