1. Medical Device Regulation - the next twenty years ?-
Mike Kreuzer OBE
Executive Director, Technical and Regulatory

2. The medical technology sector The current regulatory system
The Commission proposal
But first ABHI - what we do for our members

3. ABHI STRATEGY UK MARKET REGULATION & STANDARDS ETHICS & PRINCIPLES
Advocating policies that allow members to operate in a favorable business environment
UK MARKET
Policies that support the rapid evaluation, reimbursement and adoption of medical technologies by UK healthcare systems
INTERNATIONAL MARKETS
Policies to provide an effective gateway to foreign markets
REGULATION & STANDARDS
Policies for simple and smart regulation, providing patients with safe, effective, high quality and innovative medical technologies
ETHICS & PRINCIPLES
Policies to ensure business is conducted in the right manner

4. ABHI’s role in Regulation
ABHI founded 1989 to address EU Medical Device Legislation
European dimension to ABHI activity in this area
Today we:
Monitor developments in the regulatory system
Influence the regulators in the UK and at European level
(with Eucomed)
Provide a limited advisory role to members

5. The Virtuous Circle European Commission MHRA/ Notified Bodies UK Rep
UK Industry
(ABHI)
Eucomed

6. I. The Medical Technology Sector 'It's bigger than you may think'
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The topic number will change to II

7. The Medical Technology Sector

9. Medical technology industry in the EU
About 22,500 medical technology companies in EU
80% SMEs
95 billion EUR annual sales; 8% re-invested in EU
Nearly 500,000 employees
> 500,000 products (10,000 generic groups)
One new European patent every 38 minutes*

10. II. The Current Regulatory System
The topic number will change to III

11. Merits of the current system
Stakeholders agree Europe has best regulatory system in the world!
High level of patient safety
Availability of latest technology solutions
Appropriate costs and timings
Strong innovation capability
Countries with advanced healthcare systems like Australia, Canada use EU model
US FDA system is increasingly questioned by domestic media and policy makers
This was endorsed by a Commission Communication in mid 2011
Keep merits & basic structure, eliminate the weaknesses
Change strong countries to
Countries with well developed HC Systems

12. Weaknesses of the current system
Fragmentation: divergent interpretations and applications of rules across EEA
Regulatory gaps for certain products: Scope, reprocessing
Lack of transparency
Shortcomings in implementation
Market surveillance / post-market controls
Vigilance
Functioning of Notified Bodies
Damaged confidence in safety the system: PIP and MoM
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Immediate Measures called for following PIP
Intended to bring forward key measures before final implementation
Mainly concern NBs including Regulation due end 2012
Also Recommendation on unannounced inspections

13. The consultation 2008-2011 2008 - initial Recast Paper
2009 – changes in the Commission
2010 – the Exploratory Process
2011 – Commission Communication
PIP and HIP
the MDR Proposal
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Immediate Measures called for following PIP
Intended to bring forward key measures before final implementation
Mainly concern NBs including Regulation due end 2012
Also Recommendation on unannounced inspections

14. Immediate Measures following PIP
Intended to bring forward key measures before implementation date
Mainly concerns NBs including a Regulation due end 2012
Also, Recommendation on unannounced inspections
And there will be more
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Immediate Measures called for following PIP
Intended to bring forward key measures before final implementation
Mainly concern NBs including Regulation due end 2012
Also Recommendation on unannounced inspections

15. What we want... Access for patients to life-saving technologies
Safety for patients: PIP never again
Access for patients
to life-saving technologies
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16. III. The Commission Proposal
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Co-decision process started 26 September
Parliament / Council (Member States) and Commission have to agree
BUT much could change during this process
We now have limited influence BUT we must stay close to
- MEPs
- National Governments
AND those who might otherwise influence them e.g. HCPs

17. The Commission Proposal
We ask three questions of each proposed measure:
Does it increase Patient Safety (avoid PIP)?
Does it maintain or improve the current access patients and doctors have to life-saving technologies?
Does it encourage innovation (sustainable healthcare systems) ?

18. Key elements of the proposal: do they deliver?
Notified Bodies (national coherence, monitoring) P
Controls (e.g. unannounced visits)
Vigilance (coordination, coherent action)
Transparency (databank; public info)
Traceability / UDI
Clinical Data
Governance (coordination by DG SANCO)
Scrutiny procedure Q
Stakeholder involvement -
Reprocessing
New legal instrument & scope

19. Improvements in Notified Bodies (NBs)
Control and oversight largely on voluntary and national approaches
lack of transparency, trust and legal certainty
Current system
More rigorous designation, audit and control by Member States and Commission
Member States fees for designation and monitoring of NBs
NB enhanced compliance powers – right and duty to carry out: periodic NB audits, unannounced inspections, physical or laboratory testing on MDs, certificate suspensions, withdrawals or restrictions
EC proposal P

20. P Vigilance Current system EC proposal
Lack of coordinated exchange of information on reported incidents
Considerable variations re responses to incidents
Duplication of efforts & increased inequalities re health protection
Current system
Better coordination between national surveillance authorities
Centralized reporting
Empowerment of healthcare professionals and patients to report serious incidents at Member State level
EC proposal
Creation of EU database for centralisation of notifications and coordination of the EC P

21. Transparency and Traceability/UDI
Current system
Confidentially requirements seen as too restrictive, lack of transparency
Decreased level of public trust in the system and CE-marking
Extended database on MDs providing more information available on the quality and safety of devices on the market
Introduction of UDI system to enhance post-market safety, reduce medical errors, fight against counterfeiting, enhance purchasing and stock management by hospitals
Implant cards
EC proposal P

22. UDI – A (rapidly) Emerging Issue
UDI is cross-discipline – Patient Safety / Supply Chain
New legislation proposed in 2012
-FDA and EU (in MDD Revision)
‘All devices’ to carry a machine-readable identifier
Main purpose: patient safety (traceability)
But will be used for ‘commercial’ purposes
ABHI can influence development through Eucomed & GHTF
Programme will accelerate after PIP
BUT key concerns are:
-Proliferation of systems
-‘reciprocity’ – will healthcare authorities and providers be equipped to interact with industry? 14

23. Reinforced clinical evidence
Current system
Already legal requirements under current EU law; last improvement in 2007 (Directive 2007/42/EC)
Clearer requirements for clinical evidence
General rule that class III and implantables should be evaluated on the basis of clinical investigation data
New system of centralization of notifications and reporting system for severe adverse event
Increased protection of subjects undergoing clinical investigations
Extended post-marketing clinical follow-up
EC proposal P 21

24. P Governance Stress that this is the HOW rather than the WHAT
Current system
Good but suffers from fragmented and implementation
EC proposal
Improved cooperation and coordination between Member States
New Medical Device Coordination Group of MSs
EC coordinating role to assist MSs manage the system
Increased resources at EU level (DG SANCO, JRC)
Stress that this is the HOW rather than the WHAT P

25. New legal instrument & scope
Current system
3 Directives, fragmented implementation
Issues related e.g. borderline products or devices for aesthetic purposes
2 Regulations, delegated and implementing acts
Wider and clearer scope, e.g. to include implants for aesthetic purposes, devices containing or being made of non-viable human tissues
Relabeling and repackaging by parallel importers
Distance sales: diagnostics/therapeutics and associated services
Clarification re medical software
EC proposal P

26. Reprocessing of Single Use Devices
Current system
It is not explicitly covered by the current legislation; some labeling requirements
EC proposal
SCENIHR recommendation followed: reprocessors assigned the same duties as manufacturers; some products will be allowed reprocessing only after appropriate evaluation from EC and MSs; MSs left free to prohibit reprocessing on their territories P

27. Standards & Guidelines
Current system
Inefficiencies in development and severe disparities in implementation of guidelines
EC proposal
Better management of development and harmonized implementation of EU guidance now formal responsibility of the new Medical Device Coordination Group
Possibility of ‘Common Technical Specifications’ where no standards exist
Caveat on CTSs
BUT OK with full stakeholder involvement hence box on Formal Advisory Committee
Need for full stakeholder involvement via a formal advisory committee P

28. P - Economic Operators Current system EC proposal
Not all economic operators included
Not aligned to New Legislative Framework
EC proposal
Clearer roles and responsibilities for manufacturers, authorized representatives, importers and distributors
Inclusion of diagnostic services and internet sales
‘Qualified Person’ concept introduced to strengthen product safety
Problems may arise when considered across all organisational models and supply chain structures P -

29. P - Fees - Current system EC proposal
Industry pays government differently in each Member State in a variety of ways
EC proposal
Now explicitly expressed – national approaches
Appropriate and sustainable funding model that demonstrates benefits for both the regulator and the regulated - P -

30. Stakeholder Involvement
Current system
Medical Devices Experts Group (MDEG) open to representatives from valid stakeholders (industry, patients, physician groups)
EC proposal
No explicit reference to a stakeholder advisory committee
MDEG should be kept and given explicit reference in the legislation Q -

31. ? - Classification - Current system EC proposal
Risk-based classification: Class I (lower), Class IIa, Class IIb, Class III (Higher)
Merger of AIMD and MDD texts; devices covered by AIMD become de facto Class III
New rules (Class III): certain devices incorporating nanomaterial, devices for aphaeresis, devices ingested, inhaled or administered rectally or vaginally ….
EC proposal
Already safe products should not be unnecessarily burdened with increased bureaucracy and costs - ? -

32. Early Scientific Advice
Current system
Lacks early independent scientific advice on medical technology to Member States, European Commission and innovators
EC proposal
Mention of Joint Research Centre and Member State Experts
But no ability to offer early scientific advice
No availability of 'official' advice during development process
This was in February draft BUT was excluded in final version due to legal concerns
Greater access at EU level to sound independent scientific advice would greatly benefit MedTech SMEs - ? 30

33. Major Concern: Scrutiny of certain conformity assessments
Current system
Not included in the current legislation
Medical Device Coordination Group (MDCG) to oversee in exceptional cases the work of NBs for new class III devices in case of novel technologies, specific public health threats or uneven evaluation by a NB
NB notified Commission of all class III conformity assessment applications
MDCG’s comments made public in summary
EC proposal
Add-on to existing approval process = bureaucratic burden without safety gain
Delays between 6 months up to 1, 2, 3,… (?) years - Q 31

34. 32

35. What’s been strengthened
More rigorous designation and audit of Notified Bodies
More vigilance and coordination between national surveillance authorities
More traceability, UDI, and implant cards
Clearer requirements for clinical evidence
More effective governance structure of Member States
Wider and clearer scope
Increased regulation of reprocessing of single-use devices
More harmonized guidance and fully stakeholders’ involvement
Clearer roles and responsibilities for economic operators

36. Medical Device Regulatory System
How it will affect you?
A tougher regime but based on the same principles
Higher risk products: more evidence, more scrutiny?
Fees payable to MHRA?
Higher Notified Body fees
Cost of UDI
Enhanced control of importers and distributors

37. Six steps to a smarter legal framework for medical devices1 2 3
Only the best Notified Bodies
One approach to vigilance and market surveillance
Strengthened harmonized standards
Consistent implementation of guidelines
Increased transparency
An integrated approach: Better coordination and management 4 5 6 35

38. THANK YOU

39. Merits of EU system - Examples
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40. Merits of EU system - Examples

41. Parallels between EU MDD & US FDA systems
High level of public health protection P
Risk-based approaches
Regulatory approach
Decentralized under 27 MS National-level agencies
Centralized under 1 Country-level Agency
Overall responsibility for products on the market
National Competent Authorities (CA)
FDA
Class III reserved for highest risk
Responsibility for Pre-market approval for highest risk Class III
NB under supervision of CA
Lighter controls for lowest risk
Active Post Marketing surveillance
Periodic auditing of QMS
Recognition of international standards to demonstrate safety, performance & quality

43. ANNEX

44. The current regulatory system
Implemented at national level
Notified Bodies (NB), designated and overseen by national ‘Competent Authorities’
Pre-market approval system for high-risk devices
Controls of manufacturers and products before launch & throughout lifetime of product

45. The current regulatory system
Key elements:
Essential Requirements (ER) to demonstrate safety & performance = to be met by all devices; ER globally accepted as THE high level requirements of safety for devices
High clinical evidence across all classes of devices, not just for high risk devices
Conformity Assessment Procedure = clinical studies & data to proof safety and performance of products and quality system of the manufacturing process; all audited by NB
Additional ‘Design dossier examination’ for high risk devices
High level of inspection of the manufacturer (by Notified Body & Authorities)
Market Surveillance (preventive) & Vigilance systems (in case of incidents)
Balance between pre and post market activities

46. What does not help…