CPME in the Euractiv article “MEPs vote for stricter approval system for medical devices”Comments Off on CPME in the Euractiv article “MEPs vote for stricter approval system for medical devices”

On 26 September 2013, Euractiv reported a quote of Dr Katrín Fjeldsted, President of the Standing Committee of European Doctors (CPME): “I am confident the European Union will have strong regulations on medical devices and IVD medical device if the Council of the European Union will also uphold strong ethical principles in line with the European Parliament. CPME applauds the ENVI committee vote on medical devices and IVD medical devices. MEPs voted in favour of internationally recognised ethical principles, informed consent, transparency of data and the protection of minors participating in clinical assessments of medical devices.  Clinical assessments may not proceed without obtaining informed consent and without the approval of an Ethics Committee. Transparency measures are improved as the results of clinical investigations will be made accessible to the public upon specific requests and doctors will have full access to such data. The Council should also uphold these provisions, ensuring the safety of patients. The same principles should apply in the clinical trials regulation, which is currently being negotiated between Parliament and Council.”

To read the Euractiv article, please visit here.