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

Publikation: Bidrag til tidsskriftKommentar/debatForskning

Michaela Eikermaan, Christian Gluud, Matthias Perleth, Claudia Wild, Stefan Sauerland, Marjukka Mäkelä

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 first glance this seems a structured process. But examples such as the withdrawal of Poly Implant Prothèse (PIP) breast implants show that the process cannot guarantee safe and effective patient care.3 The certification process is inconsistent, opaque, and operates in the interests of manufacturers. It requires insufficient evidence of efficacy of the devices and no long term follow-up of patients.4 5
OriginalsprogEngelsk
TidsskriftB M J
Vol/bind346
Sider (fra-til)f2771
Antal sider1
ISSN0959-8146
DOI
StatusUdgivet - 7 maj 2013

ID: 98849329