No new centralised medical device approval agency in Europe

The debate over creating a centralized European medical device approval agency is still going strong. In large part, fueled by reactions to the PiP breast implant tragedy, many legislative groups are calling for a centralized standard throughout Europe controlled by one agency.

Many of the current medical device industries and medical professionals agree that standards need to be higher and inspections more regular, they however express concern over the added time it will then require for new medical technology to make it to the people that need it.

In March it was debated in European Parliament, headed by German MEP Dagmar Roth-Behrendt, a German MEP. She stated that she will be pushing for the proposed centralized agency and expressed the desire to mirror the United States FDA.  Putting forward that high risk devices should also require a specific pre approval and careful monitoring to avoid fraud.

Those opposing the centralised agency are voicing their opinion with a new, “Don’t lose the 3” campaign. Stating that if the centralized agency is formed it will take three to five more years for any new medical device to reach the patients the need them. Using the FDA as an example of how much delay can be expected by comparing when medical devices are available in the EU for use and when they are available in the United States.  They are working to bring public attention to the matter.

It does not seem that a decision will be coming any time in the next few months as the debates are predicted to continue with strong opinions from each side. One thing they can all agree on, something must be done to better protect the patients.

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24th September

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