On 04 July 2014, the General Secretariat of the Council of the European Union published a document addressed to the Working Party on Pharmaceuticals and Medical Devices in relation to the Council’s modifications to the Proposal for a Medical Devices Regulation.
The document specifically deals with chapter VI on Clinical Evaluation and Clinical Investigations under the MDR and the in-vitro Medical Devices Regulation.
The most significant changes brought forward by the Council’s draft Proposal concern an extended focus on the “intended use” of the device during the evaluation process. According to the published inter-institutional document, the clinical evaluation of a new device must now also contain “a comparison between the device and other treatments employed in the current clinical practice, if any” [see Art. 49(2) (d)]. The draft modifications also propose an extended deadline of 60 days (previously 35) for authorities to reply to applicants concerning the start of a clinical evaluation. Additionally, through the modifications brought to Art. 52, the Council’s draft reinforces the right of public access to the data generated during the clinical investigations.
The document published by the Council of the European Union can be found here