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Compliance In Focus
Posted by John Lehmann on Mon, Oct 14, 2013

Pre-Market Review Process Approved by EU Parliament Committee

As a follow-up to a recent blog about the European Union proposing tougher regulations thatPre Market Review Process Approved by EU Parliament Committee are similar to FDA’s pre-market approval program in the US, and the medical device industry’s concern over the legislation, it was reported that the EU parliament panel has recently approved the pre-market approval process.

The European Parliament’s Public Health Committee approved a new pre-market approval process for high-risk development devices on September 25, 2013.  The committee approved the legislation by a vote of 52 to 12 with three abstentions, and it will face a vote in the full Parliament during the October 21-24 session.

Supporters of the legislation believe the new provisions will lead to safer devices, after recent safety issues involving devices like defective breast implants and metal-on-metal hip implants became widely known and caused public outrage.  Conversely, the medical device industry feels the regulations will hamper innovation and dramatically drive R&D costs.

Currently, “nongovernmental notified bodies” are hired by device manufacturers and provide approvals for devices in the EU. The compromise reached in the committee would create new “special notified bodies” to perform pre-market conformity assessments on select high-risk devices and a central Assessment Committee for Medical Devices (ACMD) to provide oversight. Under the proposed legislation, the notified bodies must alert the ACMD of such reviews, and the ACMD can choose to review the assessments, request additional information, and review device data before it can be marketed. The new ACMD would be composed of about 600 medical experts from across Europe and contain several specialized clinical subgroups.  Many feel that the additional burdens of time and cost to device manufacturers will impact investment in small companies, where many feel that Europe has outpaced the United States.

Following review by the Parliament later this month, the European Council will consider the legislation before being sent for review by the executive European Commission. Continental elections in May 2014 may influence the proposed changes as they move through the various stages of review.

There has been much discussion on this topic, with both sides staking out their positions in a very public manner.  Please share your thoughts on the proposed EU regulations.

Photo Credit: e r j k p r u n c z y k

510(k) Current Status and Considerations

Topics: European Union, Medical Device CRO, Pre-Market Review, FDA, Medical Device Industry

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