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An Assessment of the EU Approach to Medical Device Regulation against the Backdrop of the US System

Published online by Cambridge University Press:  20 January 2017

Bernhard Lobmayr
Bernhard Lobmayr*
Affiliation:
University of South Australia, School of Commerce, CRMA Centre for Regulation and Market Analysis, Adelaide, SA, 5000, Australia. Author e-mail address: bernhard.lobmayr@unisa.edu.au.
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Abstract

A medical device is intended to alleviate a medical condition or to substitute a body function. The use of medical devices entails risks, first and foremost for patients who usually lack the necessary information, time and ability for informed decisions. Based on this, societies choose to regulate these products. Government involvement in medical device regulation seems to be more pronounced and centralised in the US than it is in the EU, where the system involves privatised elements. A consultation, initiated by the European Commission in 2008, proposed at its centre the introduction of a European medical device agency. By this the European system would follow the US benchmark. This research discusses some fundamental questions pertaining to the risk concept in medical devices, namely how risks are currently being addressed in the two most important regulatory systems of the US and the EU, and how the European system might be adjusted in the future.

Type
Articles
Information
European Journal of Risk Regulation , Volume 1 , Issue 2 , June 2010 , pp. 137 - 149
Copyright
Copyright © Cambridge University Press 2010

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References

1 Viscusi, W. K., Harrington, J. E. J. and Vernon, J. M., Economics of Regulation and Antitrust, 4th ed., (Cambridge, Massachusetts: The MIT Press 2005)Google Scholar.

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3 Ibid.

4 Ibid.

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7 US-Government, 1976, Federal Food, Drug, and Cosmetic Act (FD&C Act), Medical Device Amendments of 1976.

8 US-Government, 1990, Public Law No: 101-629, Safe Medical Devices Act of 1990; US-Government, 1992, Public Law No: 102-300, Medical Device Amendments of 1992; US-Government, 1997, Public Law No: 105-115, Food and Drug Administration Modernization Act of 1997; US-Government, 2002, Public Law No: 107-250, Medical Device User Fee and Modernization Act of 2002.

9 US-Government, “Medical Device Guidance”, 2009, available on the Internet at <http://www.fda.gov/MedicalDevices/Device-RegulationandGuidance/Overview/default.htm> (last accessed on 16 February 2010).

10 The New Approach for marketing of products was adopted in Council on 23 June 2008 and finally published in the Official Journal on 13 August 2008. It basically comprises two regulations and a decision by the European Parliament and Council: EU, 2008, Regulation No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC; EU, 2008, Regulation No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93; EU, 2008, Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC.

11 It is interesting to note that the regulation of pharmaceuticals is different, with responsibility being held by one central European agency (the European Medicines Agency EMEA).

12 This is referred to as “gold-plating”.

13 EU, 1990, DIRECTIVE 90/385/EEC – active implantable medical devices (AIMD); EU, 1993, DIRECTIVE 93/42/EEC – medical devices (MDD); EU, 1998, DIRECTIVE 98/79/EC – in-vitro diagnostic medical devices (IVD); EU, 2007, DIRECTIVE 2007/47/EC – medical devices (combining MDD and AIMD).

14 GMDN, “Global Medical Devices Nomenclature”, 2010, available on the Internet at <http://www.gmdnagency.com> (last accessed on 14 December 2009).

15 ISO, 2003, ISO13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes.

16 EU, “Nando (New Approach Notified and Designated Organisations) Information System”, 2009, available on the Internet at <http://ec.europa.eu/enterprise/newapproach/nando/index.cfm> (last accessed on 17 November 2009).

17 Viscusi, W. K., Harrington, J. E. J. and Vernon, J. M., Economics of Regulation and Antitrust, 4th ed. (Cambridge, Massachusetts: The MIT Press 2005)Google Scholar.

18 EU, 2007, DIRECTIVE 2007/47/EC – medical devices (combining MDD and AIMD).

19 Not all Member States have implemented the changes into their national laws yet.

20 Often better regulation is seen as synonymous to deregulation; see K. Boyfield, “Better Regulation without the state”, Economic Affairs EC, 2006, COM(2006) 689, A Strategic Review of Better Regulation in the European Union.

21 Zito, A. R., “European agencies as agents of governance and EU learning”, 16 Journal of European Public Policy (2009)CrossRefGoogle Scholar; Radaelli, C. M., “Whither better regulation for the Lisbon agenda?”, 14 Journal of European Public Policy (2007)CrossRefGoogle Scholar; Majone, G., “Delegation of Regulatory Powers in a Mixed Polity”, 8 European Law Journal (2002)CrossRefGoogle Scholar; S. Krapohl, “Credible Commitment in Non-independent Regulatory Agencies: A Comparative Analysis of the European Agencies for Pharmaceuticals and Foodstuffs”, SSRN eLibrary (2004); Gehring, T. and Krapohl, S., “Supranational regulatory agencies between independence and control: the EMEA and the authorization of pharmaceuticals in the European Single Market”, 14 Journal of European Public Policy (2007)CrossRefGoogle Scholar; Busuioc, M., “Accountability, Control and Independence: The Case of European Agencies”, 15 European Law Journal (2009)CrossRefGoogle Scholar.

22 Frank, S., A New Model for European Medical Device Regulation – A Comparative Legal Analysis in the EU and the USA, 1st ed. (Groningen: Europa Law Publishing 2003)Google Scholar.

23 In fact this is one of the policy recommendations Frank makes in her book.

24 EU, “Press release: Commission launches public consultation on medical devices”, 2008, available on the Internet at <http://europa.eu/rapid/pressReleasesAction.do?reference=IP/08/723amp;format=HTML&aged=0&language=EN&guiLanguage=en> (last accessed on 16 February 2010).

25 For example, per in-vitro diagnostic and per other medical devices.

26 The EUDAMED database for information exchange between Competent Authorities and potentially also Notified Bodies has been in development for several years but is not functional yet.

27 EU, “Press release: Commission launches public consultation on medical devices”, 2008, available on the Internet at <http://europa.eu/rapid/pressReleasesAction.do?reference=IP/08/723&format=HTML&aged=0&language=EN&guiLanguage=en> (last accessed on 16 February 2010).

28 This was suggested in interviews I conducted with representatives for the European Commission, Enterprise and Industry Directorate – General Unit F3 – Cosmetics and Medical Devices and EUCOMED, the European medical device industry lobbying organisation in July 2008 and is also apparent from many of the responses and comments to the consultation.

29 For example, the Declaration of Conformity, certificates by Notified Bodies, and other documents.

30 EU, 1998, DIRECTIVE 98/79/EC – in-vitro diagnostic medical devices (IVD).

31 Fragmentation indeed exists in the regulatory framework. There are Directives, national implementation laws, voluntary harmonised European standards, providing presumption of conformity with the obligatory essential requirements, adopted by the European Standards Bodies (CEN, CENELEC and ETSI), Commission communications and interpretative documents informing Member States on how the European Commission expects EU legislation to be applied, guidance documents, the so-called MEDDEVs, adopted by authorities in co-operation with stakeholders, that represent the consensus of authorities and stakeholders on interpretative issues, recommendations elaborated by the Notified Bodies, involved in conformity assessment, that reflect their consensus position on technical interpretation, guidance of a general nature on so called “New Approach” legislation, etc.

32 The EUCOMED response states on page 27: “The suggested transformation of the medical devices legislative instrument into a Regulation has some merit and needs to be carefully evaluated. Moving from a regime where some requirements are left to the national authorities, to something that will be clearly and consistently defined will require considerable effort. Care will need to be exercised to ensure that the process of developing such a new legislative instrument does not end up with the adoption of more specific and prescriptive requirements without due justification The cost and impact of this can only be evaluated on the basis of a proposal.”

33 For example, products which fall under the Advanced Therapy Medicinal Products Regulation, medical devices consisting of non-viable human cells or tissues, cosmetic implants, tattoo needles, cosmetic contact lenses, etc.

34 For example, the introduction of a European agency for medical devices.

35 Conformité Européenne – CE marking declares the completion of conformity assessment and that the equipment or assembly complies with the provisions of the Directive and meets the essential safety requirements.

36 The risk class of “highest risk” is currently not defined.

37 For example., the EUCOMED response states on page 15: “Behind all of the Commission's proposals in this Section (and indeed in much of the rest of the Commission's paper) lies an assumption that EMEA would somehow be uniquely suited to bringing to bear an expertise on the evaluation of “highest risk” devices that would greatly enhance the situation and that this would not be possible in any other way. We reject such an assumption. There is no evidence that the current system is not working.”

38 Notified Bodies operate under different national designation and monitoring requirements, often with different levels of transparency, different interpretation of tasks, and different levels of scrutiny. The recast consultation proposes the introduction of a requirement for annual reports by Notified Bodies, an information exchange between Notified Bodies, a cooperation of authorities with regard to Notified Bodies, the introduction of a catalogue of sanctions and penalties, measures to stop forum shopping, and also a link between the application of safeguard clauses and a withdrawal of certificates issued to the manufacturer in question.

39 MHRA, 2008, UK Response to Commission questionnaire.

40 The GHTF is an international forum of medical device regulators and industry from the US, the EU, Japan, Canada and Australia for the harmonisation of medical device law. The European Commission web pages state that “[T]he active participation of Europe in GHTF aims at contributing to the definition of a global regulatory model for medical device and diagnostics technology and the drafting of guidance documents agreed by consensus.” EU, “International Cooperation”, 2010, available on the Internet at <http://ec.europa.eu/enterprise/sectors/medical-devices/international-cooperation/index_en.htm> (last accessed on 19 February 2010).

41 Some countries have more than one government department which commented on the regulatory recast. For example, there are four submissions from German governmental bodies. Another example is Finland where there is one submission each from the National Agency for Medical Devices and the Ministry of Agriculture and Forestry. This is not to say that these bodies do not provide important inputs to the discussion, but it suggests that there probably was a lack of time to coordinate national positions for the consultation.

42 EU, “Recast of the medical device directives – summary of responses to the public consultation”, 2008, available on the Internet at <http://ec.europa.eu/enterprise/sectors/medical-devices/files/recast_docs_2008/responses/responses_public%20consultation_recast_en.pdf> (last accessed on 16 February 2010).

43 Ibid.

44 The EUCOMED response states on page 1: “ … we are concerned at the numerous assertions in the Commission's consultation document that there are substantial problems with the regulation of devices in Europe and the repeated indications that the Commission considers these problems can be addressed by submitting a substantial section of the Industry (e.g., some Class III and active implantable devices) and substantial aspects of the regulatory regime (borderline products and device vigilance) to EMEA. Not only does the Device Industry think that this would be entirely detrimental to the interests of the public as well as the industry, but it sees no evidence of either the alleged problems or the reasons why EMEA would present the appropriate solution if those problems did indeed exist.”

45 EU, “Recast of the medical device directives - summary of responses to the public consultation”, 2008, available on the Internet at <http://ec.europa.eu/enterprise/sectors/medical-devices/files/recast_docs_2008/responses/responses_public%20consultation_recast_en.pdf> (last accessed on 16 February 2010).

46 A. Maxwell, Proposals for EU regulatory change: a labyrinthine puzzle (Clinica 2008).

47 EU, “Community agencies”, 2010, available on the Internet at <http://europa.eu/agencies/community_agencies/index_en.htm> (last accessed on 16 February 2010).