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Regulatory Focus™ > News Articles > Industry Pans EU Plan to Implement Medical Device Registry

Industry Pans EU Plan to Implement Medical Device Registry

Posted 27 April 2012 | By Alexander Gaffney, RAC 

One of the medical device industry's biggest organizations is sounding off against a plan by the European Parliament to implement postmarketing medical device implant registry system that aims to protect consumers against the types of problems currently plaguing the European market.

As Regulatory Focus reported on 27 April, the European Parliament released the plans after two prominent medical device failures-metal-on-metal hip implants manufacturer by, among others, Johnson & Johnson subsidiary DePuy and breast implant products manufactured by now-defunct French manufacturer Poly Implant Prothese.

Both products have been linked to early failure and possible harms to patients, leaving regulatory authorities across Europe scrambling to formulate responses and calling for additional regulatory measures.

In response to today's plan, a prominent group is speaking out, saying the plans generate "mixed feelings."

Medical device trade group Eucomed said in a statement while the measures "will improve the current legislative framework for medical devices and have a positive effect on patient safety," the group does not see the need for a medical device approval system similar to the one that currently exists in the US.

"Eucomed does not understand the need to call for a pre-market authorisation system for Class III devices as Europe currently has a de factoapproval system for these devices," the group said in a statement. "Europe needs smart regulation that makes efficient and effective use of existing resources and involved structures (European Commission, Competent Authorities, Notified Bodies and industry) so as to retain a simple, adaptable and highly efficient system and merit public confidence."

The proposal leaves open the possibility that a pre-market authorization system for medical devices could be established, explained Eucomed, and this area needs further clarification.

"Suggesting that a pre-market authorisation system is needed is inaccurate as Europe currently has a de-facto approval system for Class III devices," concluded Eucomed.

Read more:

Eucomed - European Parliament's Resolution on PIP received with mixed feelings by industry

European parliament - PIP breast implants: "learn the lessons of this fraud"

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