Regulatory Focus™ > News Articles > European Parliament Committee Says Changes to Proposed Device Legislation Needed

European Parliament Committee Says Changes to Proposed Device Legislation Needed

Posted 31 July 2013

A new opinion report just published by the European Parliament's Committee on the Internal Market and Consumer Protection on the Committee on the Environment, Public Health and Food Safety's (ENVI) medical device and IVD proposals calls for changes to be made, citing the proposals' potential to be overly restrictive to the "free movement of products."


In April 2013, ENVI made an unprecedented proposal to require many medical devices to undergo a premarket authorization procedure similar in concept to one established by the US Food and Drug Administration. Currently, such medical products undergo a largely decentralized regulatory process in which individual states primarily oversee products, and companies' adherence to regulations is checked by organizations known as notified bodies.

That system, however, has been under fire as of late. Thanks to several high-profile safety scandals-defective breast implants, faulty hip replacements and dangerous vaginal mesh implants among others-legislators have begun to study whether devices marketed in the EU were being adequately regulated, and if not, how to best do so.

That process has largely fallen to ENVI Rapporteur Dagmar Roth-Behrendt, an influential member of the European Parliament from Germany who released draft legislation in April 2013. [Editor's Note: Read our analysis of her legislation here.]

But Roth-Behrendt's report has received fierce pushback from the medical device industry, which has launched a campaign to table the measure, claiming it would rob EU patients of their early access to cutting-edge medical therapies.

Proposed Changes

However, a new report from one of the European Parliament's own committees is reinforcing the ENVI proposal even as it calls for changes to be made to ensure "the benefits of our internal market."

The report from the Committee on the Internal Market and Consumer Protection lists a plethora of recommendations meant to increase its consistency, decrease the potential for over-reach, and better regulate certain types of devices.

For example, changes would restrict EMA's regulation of nanomaterials only to medicinal products. The existing regulation would have permitted any nanomaterial that interacted with the body to be regulated by EMA. Another proposed change calls for compatibility testing when two or more separate parts are implanted into the human body and are intended to work with one another.

Other proposed changes include:

  • Medical devices manufacturers will be required to purchase liability insurance to ensure that insolvency does not affect patients harmed by a device
  • Manufacturers will need to prove their device can only be used once before labeling it as a "single-use device," and a new definition is proposed for "multiple-use device"
  • Class III medical device manufacturers should be required to submit postmarketing reports to regulators

The entire 82-page report is available on the European Parliament's website.

Committee on the Internal Market and Consumer Protection: Opinion Report


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