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Revision of the Regulatory Framework for Medical Devices in the European Union: The Legal Challenges

  • Leigh Hancher (a1) and Maria Eva Földes (a2)

Extract

This special edition of the European Journal of Risk Regulation deals with a highly topical, complex and controversial subject matter – the reform of the regulation of medical devices in the European Union.

At first sight, and as further detailed in the following articles, there appears to be a general consensus about the need to improve the EU (and indeed the US) regulatory framework on medical devices, especially for high-risk categories of devices. Stakeholders including representatives of the industry, patient and consumer organizations, national authorities, healthcare professionals, agree that there is a need for change. However, opinions differ on what needs to be changed and how. Three alternatives for reform of the current EU systemof regulation have been debated over the past years: the adoption of a pharmastyle system of pre-market authorisation; maintaining the status quo but strengthening implementation and supervision in the Member States; or finally, introducing common technical specifications together with specific guidelines for certain high-risk devices.

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1 John Brennan, Eucomed, “Revision of the EU Regulatory Framework”, presentation held at the conference “Revising Medical Devices Regulation: The Legal Challenges”, Tilburg, 29 January 2013.

2 See however, the recent Ph.D. thesis of Nupur Chowdhury, “Pursuing Legal Certainty in Multilevel Regulation, a Sociolegal Study of Medical Device and Pharmaceutical Regulation in Europe” (Ph.D. thesis on file at the University of Twente, 2013).

3 See, for the definition of medical devices, active implantable medical devices and in-vitro medical devices, Council Directive 90/385/EEC on the Approximation of the Laws of the Member States Relating to Active Implantable Medical Devices, OJ 1990 L 189/17; Council Directive 93/42/EEC Concerning Medical Devices, OJ 1993 L 169/1 (commonly known as the Medical Device Directive); Directive 98/79/EC of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices, OJ 1998 L 331/1.

4 See also Commission Staff Working Document: Impact Assessment Accompanying the Document Proposal for a Directive of the European Parliament and of the Council Relating to the Transparency of Measures Regulating the Prices of Medicinal Products for Human Use and Their Inclusion in the Scope of Public Health Insurance Systems, SWD(2012) 30, ANNEX 9, at p. 53.

5 See the Eucomed calculations based on data obtained from National Associations of 15 countries. Eucomed, “Medical Technology – Key facts and Figures”, available on the Internet at: <www.eucomed.org/facts-figures> (last accessed on 23 September 2013). Europe refers to the EU Member States plus Norway and Switzerland.

6 Eucomed, “Innovation, Research & SMEs”, available on the Internet at: <www.eucomed.org/key-themes/innovation-research-smes> (last accessed on 23 September 2013).

7 European Commission, Guide to the Implementation of Directives Based on the New Approach and the Global Approach (Luxembourg: Office for Official Publications of the European Communities, 2000). The New Approach dates back to the 1985 adoption of the Council Resolution on a New Approach to Technical Harmonization and Standards, OJ 1985 C 136.

8 See Council Directive 93/42/EEC Concerning Medical Devices, Council Directive 90/385/EEC on Active Implantable Medical Devices, and Directive 98/79/EC of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices, supra note 4.

9 Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 Amending Council Directive 90/385/EEC on the Approximation of the Laws of the Member States Relating to Active Implantable Medical Devices, Council Directive 93/42/EEC Concerning Medical Devices and Directive 98/8/EC Concerning the Placing of Biocidal Products on the Market, OJ 2007 L 247/21.

10 European Commission Guide, supra note 8.

11 See ANNEX IX on the classification criteria of Council Directive 93/42/EEC Concerning Medical Devices, supra note 4.

12 See Council Directive 93/42/EEC Concerning Medical Devices, Council Directive 90/385/EEC on Active Implantable Medical Devices, and Directive 98/79/EC of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices, supra note 4.

13 In October 2013, there were 75 bodies notified to operate under Council Directive 93/42/EEC Concerning Medical Devices, 19 bodies notified under Council Directive 90/385/EEC on Active Implantable Medical Devices and 26 bodies notified under Directive 98/79/EC of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices. European Commission, Directorate General for Enterprise and Industry, “Notified Bodies”, available on the Internet at: <www.ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.main> (last accessed on 26 October 2013).

14 See Art. 14a of Council Directive 93/42/EEC Concerning Medical Devices, supra note 4.

15 Commission Decision on the European Databank on Medical Devices (EUDAMED), OJ 2010 L 102/45.

16 See also European Commission, “European Databank on Medical Devices – EUDAMED”, 4 June 2013, available on the Internet at: <www.ec.europa.eu/consumers/sectors/medical-devices/market-surveillance-vigilance/eudamed/> (last accessed on 26 October 2013).

17 See also European Commission Directorate General for Health and Consumers, Revision of the Medical Device Directives, 26 October 2013, available on the Internet at <www.ec.europa.eu/health/medical-devices/documents/revision/index_en.htm> (last accessed on 26 October 2013).

18 See the summary of responses published by the European Commission. European Commission, “Recast of the Medical Devices Directives: Summary of Responses to the Public Consultation”, ENTR/F/3/D(2008) 39582, 5 December 2008, available on the Internet at: <www.ec.europa.eu/health/medical-devices/files/recast_docs_2008/responses/responses_public_consultation_recast_en.pdf> (last accessed on 24 September 2013).

19 See the summary of responses published by the European Commission: European Commission, “Revision of Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on In Vitro Diagnostic Medical Devices: Summary of Responses to the Public Consultation”, 23 February 2011, available on the Internet at: <www.ec.europa.eu/health/medical-devices/files/recast_docs_2008/ivd_pc_outcome_en.pdf> (last accessed on 24 September 2013).

20 Council Conclusions on Innovation in the Medical Device Sector, OJ 2011 C 202/7.

21 See European Commission, “Roadmap”, 7 November 2011, available on the Internet at: <www.ec.europa.eu/governance/impact/planned_ia/docs/2008_sanco_081_proposal_medical_devices_en.pdf> (last accessed on 24 September 2013).

22 European Commission Press Release, “Medical Devices: European Commission Calls for Immediate Actions – Tighten Controls, Increase Surveillance, Restore Confidence”, 9 February 2012, available on the Internet at: <www.europa.eu/rapid/pressReleasesAction.do?reference=IP/12/119&format=HTML&aged=0&language=EN&guiLanguage=en> (last accessed on 24 September 2013).

23 European Commission Press Release, supra note 23.

24 European Parliament Resolution on Defective Silicone Gel Breast Implants Made by French Company PIP, P7_TA(2012)0262.

25 Commission Proposal for a Regulation of the European Parliament and of the Council on Medical Devices and Amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009, COM(2012) 542; Commission Proposal for a Regulation of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices, COM(2012) 541.

26 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Safe, Effective and Innovative Medical Devices and In Vitro Diagnostic Medical Devices for the Benefit of Patients, Consumers and Healthcare Professionals, COM(2012) 540.

27 European Parliament Committee on the Environment, Public Health and Food Safety, Draft Report on the Proposal for a Regulation of the European Parliament and of the Council on Medical Devices, and Amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 (COM(2012)0542 – C7-0318/2012 – 2012/0266(COD)); European Parliament Committee on the Environment, Public Health and Food Safety, Draft Report on the Proposal for a Regulation of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices (COM(2012)0541 – C7-0317/2012 – 2012/0267(COD)).

28 The conference presentations are available on the Internet at: <www.lexxion.eu/conferences>.

Revision of the Regulatory Framework for Medical Devices in the European Union: The Legal Challenges

  • Leigh Hancher (a1) and Maria Eva Földes (a2)

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