Analysis

Commentary: Europe needs a central, transparent, and evidence based regulation process for devices

BMJ 2013; 346 doi: https://doi.org/10.1136/bmj.f2771 (Published 07 May 2013) Cite this as: BMJ 2013;346:f2771
  1. Michaela Eikermann, head of department of evidence based medicine1,
  2. Christian Gluud, head of department2,
  3. Matthias Perleth, chairman3,
  4. Claudia Wild, director4,
  5. Stefan Sauerland, head of department5,
  6. Iñaki Gutierrez-Ibarluzea, knowledge manager6,
  7. Sunya-Lee Antoine, research associate1,
  8. Jacques Demotes-Mainard, project coordinator7,
  9. Edmund A M Neugebauer, director1
  10. On behalf of signatories of our open letter to the European Union*
  1. 1Institute for Research in Operative Medicine, Faculty of Health, School of Medicine, Witten/Herdecke University, D-51109 Cologne, Germany
  2. 2Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Copenhagen, Denmark
  3. 3German Society for Technology Assessment in Health Care, Berlin, Germany
  4. 4Ludwig Boltzmann Institute of Health Technology Assessment, Vienna, Austria
  5. 5Non-Drug Interventions, Institute for Quality and Efficiency in Healthcare (IQWiG), Cologne, Germany
  6. 6Osteba, Basque Office for Health Technology Assessment, Vitoria-Gasteiz, Spain
  7. 7INSERM, Institut Thematique Sante Publique, Paris, France
  1. Correspondence to: E A M Neugebauer Edmund.Neugebauer{at}uni-wh.de

Last September, the European Commission published proposals to update regulations for medical devices in order to improve patient safety.1 The proposals are being discussed by the European parliament where critical debate is being led by the Committee on Environment, Public Health and Food Safety.

Medical devices range from bandages to life support machines, and manufacturers classify them into four risk categories from low (such as urine drainage bags) to high risk (such as drug eluting cardiac stents) according to EU rules.2 The risk associated with the device depends on the duration of contact with the body, invasiveness, and whether it has a local or a systemic effect. Medium and high risk devices must be certified by one of the notified bodies, organisations that are accredited to assess a product’s compliance with EU legislation (CE mark).

At a …

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