One of the requirements introduced by directive 2007/47 revolves around the obligation to report Severe Adverse Events (SAE) occurring during clinical investigations to National Authorities (NA). At its last meeting, the Clinical Investigation and Evaluation Working Group (CIE) has finalised a guidance document proposal for implementing this new requirement. The CIE was mandated by the Medical Devices Experts Group (MDEG) to draft this document with the aim of harmonising reporting practices across the EU and reducing the workload for both manufacturers and regulators.
As a recognised stakeholder of the CIE and the MDEG, Eucomed has contributed to drafting the document and is satisfied with the results although the association believes that the reporting system could have been further simplified. Additionally, Eucomed would like to see the provisions of this guidance document adopted as such by all member states without deviations or additional national requirements.
The draft guidance document will be presented at the next MDEG meeting (30 November) for final endorsement and subsequent publication on the Commission Website.