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Regulatory Focus™ > News Articles > 2020 > 7 > Updates on MDR implementation, transparency; MDCG posts CEAR template

Updates on MDR implementation, transparency; MDCG posts CEAR template

Posted 17 July 2020 | By Michael Mezher 

Updates on MDR implementation, transparency; MDCG posts CEAR template

The European Commission over the past week provided several updates on the implementation of the Medical Device Regulation (MDR) and released a fact sheet explaining the information that will be available to the public about devices under the regulation.
 
The Commission’s Medical Devices Coordination Group (MDCG) also released a template for clinical evaluation assessment reports (CEAR) for 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. CEARs in this format will also support specific additional requirements such as the clinical evaluation consultation procedure and reviews by designating authorities,” MDCG writes.
 
According to a timetable for its MDR joint implementation plan, the Commission says it plans to endorse a guidance on administrative and technical solutions in absence of its European database on medical devices (Eudamed) and a position paper on the use of the Eudamed actor registration module sometime in Q3 2020.
 
By the end of July, the Commission says it expects to appoint members to its expert panels for medical devices, which are needed for consultations on clinical evaluations of high-risk devices under MDR. The Commission also expects to make the panels available for clinical evaluation consultation procedures (CECP) and performance evaluation consultation procedures (PECP) by Q4 2020. (RELATED: EC explains new MDR, IVDR rules for designating expert device panels, Regulatory Focus 11 September 2019).
 
The Commission also released a fact sheet explaining what information will be made public according to transparency obligations under MDR, though some of those requirements will not be applicable until Eudamed is fully functional. (Eudamed to launch in 2022 for both devices and IVDs, Regulatory Focus 30 October 2019).
 
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 writes.
 
Once fully functional, the public will have access to information on manufacturer, authorized representative and importer registration, device registrations, a list of notified bodies, the scientific opinions of expert panels, clinical investigation reports and summaries, summaries of safety and clinical performance reports for certain high-risk devices, partial access to manufacturer incident reports and field safety notices and summaries of the results of market surveillance activities.
 
Outside Eudamed, the public will have access to information regarding national measures by competent authorities on the marketing of reprocessed single-use devices, the types and levels of fees by member states, national measures pertaining to notified bodies, notified body fees, summaries of member state reports on monitoring and on-site assessment activities for notified bodies, and the Commission’s annual summary report of peer review activities for authorities responsible for notified bodies.
 
The Commission notes that the information available via Eudamed is not strictly limited to the current list. “More information could progressively be made available in Eudamed based on experience gained on the impact of transparency inn particular on the various reporting activities and the way this information is beneficial to the public,” the Commission writes.

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