The European Commission (EC) have recently provided several updates on the implementation of the Medical Device Regulation (MDR).
Firstly, the EC’s Medical Devices Coordination Group (MDCG) have released a template for clinical evaluation assessment reports (CEAR), to be used by notified bodies to document their assessments of clinical evidence for medical devices undergoing conformity assessments.
A harmonised CEAR template provides a standardised method for documenting the notified body’s assessment of the manufacturer’s clinical evaluation and related documents.
Secondly, the EC has published a timetable for the MDR joint implementation plan, through which it plans to endorse a guidance on administrative technical solutions in the delayed absence of Eudamed. It also plans to release a position paper on Eudamed in Q3 2020.
Finally, a factsheet has been released explaining what information will be available for public access through transparency obligations under MDR. The fact sheet breaks down different types of information that will be publicly accessible based on whether it will be found within or outside Eudamed.
“The public access to the information registered in the different modules of Eudamed is extensive. It will provide citizens with the possibility to search for information related to devices, their manufacturers and certificates of conformity, the notify bodies which have delivered them and some information related to the clinical investigations and the incident reports associated with the devices.”
The Commission also states that more information could progressively be made available in Eudamed based on experience gained on the impact of the transparency obligations.
For the latest updates on EU MDR, be sure to check back to the Regulis News page.