Analysis

Trials are needed before new devices are used in routine practice in Europe

BMJ 2013; 346 doi: https://doi.org/10.1136/bmj.f1646 (Published 18 March 2013) Cite this as: BMJ 2013;346:f1646
  1. Philipp Storz-Pfennig, consultant,
  2. Mechtild Schmedders, consultant,
  3. Matthias Dettloff, consultant
  1. 1GKV-Spitzenverband – Medicine, Mittelstrasse 51, Berlin D-10117, Germany
  1. Correspondence to: P Storz-Pfennig Philipp.Storz{at}gkv-spitzenverband.de
  • Accepted 8 March 2013

As the EU debates new legislation to regulate medical devices, Philipp Storz-Pfennig, Mechtild Schmedders, and Matthias Dettloff provide examples from Germany to show why the current proposals do not go far enough and call for further assessment after market approval

A growing number of examples, including metal on metal hip implants and breast implants, show the harm that can result from new devices and procedures being introduced without a rigorous assessment of their safety and efficacy.1 2 3 4 5 6 7 This has led to the wide acceptance that the system for regulating medical devices, particularly in the European Union (EU) is flawed. The European parliament is currently debating proposals put forward last year by the European Commission to reform the EU legislation for medical devices and in vitro diagnostics.8 9

However, the new proposals will not change market access to new devices appreciably.10 Notified bodies will continue to grant market approval (through CE certificates), although quality assurance will be stepped up—the European Commission will have to set up a medical devices coordination group to supervise notified bodies and advise on their assessments of new high risk devices and diagnostic tests, and there will be harmonised criteria for accreditation. After a device is approved, there will also be stronger postmarketing surveillance. The proposals include the introduction of a “unique device identifier” and unheralded inspections of device manufacturers by notified bodies.

The proposals fall short of what is required to prevent high risk devices being used without reliable evidence on their safety and efficacy—as is required for new drugs.11 And manufacturers will still be free to define and amend the intended purpose of their devices without having to get approval from any authority. EU member states will therefore still have to make decisions about …

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