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Are We Wasting a Good Crisis? The Revision of the EU Medical Devices Directives and the Impact of Health Data Rules

Published online by Cambridge University Press:  20 January 2017

Alex Denoon  and
Erik Vollebregt
Alex Denoon
Affiliation:
Lawford Davies Denoon, London
Erik Vollebregt
Affiliation:
Axon Lawyers, Amsterdam
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Extract

The three Directives concerning medical devices are currently under revision and a long process that started with a consultation in 2008 seems to be nearing its conclusion with two Regulation proposals in the pipeline and at the time of writing under discussion in the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI Committee). In this article we examine if the proposed Regulation for medical devices will deliver on the promises. We will focus on what we know to be the hot topics for industry. Since the article is forward- looking about draft legislation currently in the legislative process, it is by necessity speculative on points and the proposals may have changed by the time this article is printed.

Type
Symposium on the EU's New Medical Devices Regulatory Framework
Information
European Journal of Risk Regulation , Volume 4 , Issue 4 , December 2013 , pp. 437 - 442
Copyright
Copyright © Cambridge University Press 2013

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References

1 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; Directive 98/79/EC of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices, OJ 1998 L 331/1.

2 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.

3 European Parliament Committee on the Environment, Public Health and Food Safety Press Release, “PIP Breast Implants: Learn the Lessons of This Fraud”, 25 April 2012, available on the Internet at: <www.europarl.europa.eu/sides/getDoc.do?pubRef=-%2f%2fEP%2f%2fNONSGML%2bIMPRESS%2b20120423IPR43732%2b0%2bDOC%2bPDF%2bV0%2f%2fEN> (last accessed on 17 September 2013).

4 European Commission Press Release IP/12/119, “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 17 September 2013).

5 Commission Staff Working Document: Impact Assessment of the Revision of the Regulatory Framework for Medical Devices, SWD(2012) 273.

6 The additional scrutiny measures are set out in Article 44 of the proposed Regulation on Medical Devices, supra note 4.

7 US Food and Drug Administration (FDA), “Unsafe and Ineffective Devices Approved in the EU That Were Not Approved in the US”, May 2012, available on the Internet at: www.elsevierbi.com/∼/media/Supporting%20Documents/The%20Gray%20Sheet/38/20/FDA_EU_Devices_Report.pdf (last accessed on 17 September 2013).

8 European Medicines Agency, “Road map to 2015, The European Medicines Agency's Contribution to Science, Medicines and Health”, 16 December 2010, available on the Internet at: <www.ema.europa.eu/docs/en_GB/document_library/Report/2011/01/WC500101373.pdf> (last accessed on 17 September 2013).

9 Eichler, HG, Oye, K, Baird, LG, Abadie, E, Brown, J, Drum, CL, Ferguson, J, Garner, S, Honig, P, Hukkelhoven, M, Lim, JC, Lim, R, Lumpkin, MM, Neil, G, O’Rourke, B, Pezalla, E, Shoda, D, Seyfert-Margolis, V, Sigal, EV, Sobotka, J, Tan, D, Unger, TF, Hirsch, G, “Adaptive licensing: taking the next step in the evolution of drug approval”, 91(3) Clin Pharmacol Ther. (2012), pp. 426 et sqq CrossRefGoogle ScholarPubMed.

10 See by way of example, Hans-Georg Eichler, “Adaptive Licensing: A Useful Approach for Drug Licensing in the EU?” presentation held at the European Medicines Agency (EMA), London, March 2012.

11 Vollebregt, Erik R., “Is the European Commission Meeting the Needs of Patients, Healthcare Professional and Manufacturers with the new medical devices regulation proposal?”, Journal of Medical Devices Regulation (2013), pp. 6 et sqq Google Scholar.

12 Commission Guidelines on Medical Devices Post Market Clinical Follow-up Studies: A Guide for Manufacturers and Notified Bodies, MEDDEV 2.12/2 rev2, January 2012.

13 France is the Member State that has been publicly pro-EMA market approval from the start.

14 She helped draft the legislation that provided the legal basis for the EMA.

15 This is what the Member States want: not too much transfer of sovereignty to the EU.

16 E.g., the Medical Devices Coordination Group (MDCG) and other committees.

17 The Commission will move to chair all committees and coordinate all activity in relation to the proposed Regulation.

18 See for details, Erik Vollebregt's medical devices legal and regulatory blog, available on the Internet at <medicaldeviceslegal.com/2013/07/25/in-the-mean-time-joint-immediate-action-plan-and-other-things-over-the-summer/> (last accessed on 17 September 2013).

19 Code of Conduct for Notified Bodies under Directives 90/385/EEC, 93/42/EEC and 98/79/EC, “Improving Implementation of the European CE Certification of Medical Devices Through Harmonization of Quality and Competence of Notified Bodies”, version 3.0., 10 October 2012, available on the Internet at: <www.team-nb.org/documents/2013/Code_of_Conduct_Medical_Notified-Bodies_v3-0.pdf> (last accessed on 17 September 2013).

20 See e.g. Viviane Reding, Vice-President of the European Commission, EU Commissioner for Justice, “Data protection reform: restoring trust and building the digital single market”, speech 13/720 held at the 4th Annual European Data Protection Conference, Brussels, 17 September 2013.

21 See by way of example, the strongly worded statement by many of Europe's leading biomedical research bodies and patient groups “Impact of the draft European Data Protection Regulation and proposed amendments from the rapporteur of the LIBE committee on scientific research”, March 2013, available on the Internet at: www.wellcome.ac.uk/stellent/groups/corporatesite/@policy_communications/documents/web_document/wtvm054713.pdf (last accessed on 17 September 2013).

22 See for an overview Erik Vollebregt, “ENVI's IVD regulation amendments”, available on the Internet at: <http://medicaldeviceslegal.com/2013/05/28/envis-ivd-regulation-amendments/> and “Rapporteur Liese's IVD regulation amendments are out: not so horizontal as expected”, available on the Internet at: medicaldeviceslegal.com/2013/04/17/rapporteur-lieses-ivdregulation-amendments-are-out-not-so-horizontal-as-expected/ (last accessed on 17 September 2013).