CPME in the Euractiv article “US doctors look with envy at Europe’s medical devices approval scheme”Comments Off on CPME in the Euractiv article “US doctors look with envy at Europe’s medical devices approval scheme”

On 3 July 2013, Euractiv reported a quote of Dr Katrín Fjeldsted, President of the Standing Committee of European Doctors (CPME): “Mandatory approval of the ethics committee for medical devices before the clinical investigation begins is crucial for patient safety. European doctors consider this essential to be taken on board in the Regulation and welcome the report of MEP Dagmar Roth-Behrendt (amendments 15 and 84) which upholds internationally recognised standards of protection (Declaration of Helsinki, Rev. 2008, paragraph 15). Notwithstanding the different ramifications of the proposal for patient safety and innovation, CPME reminds, just like clinical trials for medicinal products, that the start of clinical investigations should only be granted after positive approval of the ethics committee. CPME calls on members of the European Parliament to maintain the mandatory role of ethics committees and vote in favour of amendments 15 and 84 in September.”

 

To view the Euractiv article, please visit here.