english.prescrire.org > Spotlight > Archives : 2012 > European medical device regulation: an entire overhaul is urgently needed

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European medical device regulation: an entire overhaul is urgently needed

In a published response to the article "Medical devices: EU approval system leaves door open for dangerous devices" (BMJ online, 24 October 2012), Prescrire, together with the AIM, ESIP, the ISDB and the MiEF, underlines the failings of the European device regulation as demonstrated by the recent BMJ investigation, and recommends several important changes if patient safety is to be at the heart of the new regulation.

During the past decade, several medical devices that were rejected in the US – thanks to the Food and Drug Administration’s preapproval procedure – were marketed in Europe, and subsequently removed from the market on safety grounds (1).

And yet, in the aftermath of the PIP breast implant scandal, the European Commission’s proposal to revisit the European device regulation blatantly disregards the need to ensure efficacy as well as safety for high-risk medical devices to be used by European citizens (2).

Even when it comes to high-risk medical devices, the Commission keeps on:

  • requiring manufacturers to demonstrate the device’s “performance” (compliance to technical specifications) rather than requiring demonstration of clinical efficacy;
  • relying on notified bodies, despite the overwhelming evidence that their conflicts of interest make them unfit for this purpose.

The recent BMJ investigation using a fake and dangerous hip implant is most enlightening (3).

In order to put patient safety at the heart of the new regulation, the Association Internationale de la Mutualité (AIM), the European Social Insurance Platform (ESIP), the International Society of Drug Bulletins (ISDB) and the Medicines in Europe Forum (MiEF) recommend the following changes:

  • the demonstration of clinical efficacy – not of mere “performance” – and of clinical safety for high-risk medical devices, prior to the granting of a centralised marketing authorisation;
  • health authorities – not notified bodies – should be responsible for the granting of such a marketing authorisation, their decision having to be based on high-quality clinical studies;
  • the rights of harmed patients ought to be strengthened by improving access to product information, upholding the liability of medical device manufacturers, and easing the standard of causality where it is objectively possible that the device may have caused the harm (reversing the burden of proof) (2).

> Read this response online at bmj.com

©Prescrire 31 October 2012, together with AIM, ESIP, the ISDB and the MiEF

References:
1- US Food and Drug Administration “Unsafe and Ineffective Devices Approved in the EU that were Not Approved in the US" Report; May 2012.Freely accessible at: http://www.elsevierbi.com/~/media/Supporting%20Documents/The%20Gray%20Sheet/ 38/20/FDA_EU_Devices_Report.pdf 
2- AIM, ESIP, ISDB, MiEF “High-risk medical devices should be made subject to approval at European level and the rights of patients harmed should be improved”Joint Position Paper ; 22 October 2012 : 7 pages. Freely accessible at:
http://english.prescrire.org/Docu/DOCSEUROPE/20121022_ESIP-AIM-ISDB-MiEF-MedicalDevices.pdf
3- Cohen D “EU approval system leaves door open for dangerous devices”
BMJ 2012; 354:e7173 doi: 10.1136/bmj.e7173.
Read this response
online at bmj.com

For more information:
 
High-risk medical devices
should be made subject to
approval at European level
and the rights of patients
harmed should be improved
Joint analysis by
AIM, ESIP, ISDB, MiEF
(October 2012)
Pdf, free

See also:

Recap: working together
to improve healthcare
policy in Europe
english.prescrire.org
Online dossier
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