New MDCG Guidance Documents!


MDCG 2020-13 Clinical evaluation assessment report template 

The European Commission’s Medical Devices Coordination Group (MDCG) published MDCG 2020-13 which is a template for clinical evaluation assessment reports (CEAR). A CEAR is a report used by the notified bodies to document the conclusion of their assessments of the clinical evidence presented by the manufacturer in the clinical evaluation report (CER) and the related clinical evaluation that was conducted for medical devices undergoing conformity assessments under Regulation 2017/745 Medical Devices Regulation (MDR). 

The guidance clearly states that 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 2020-14 Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out
under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR) 

The European Commission’s Medical Devices Coordination Group (MDCG) published MDCG 2020-14 explaining how Notified Bodies may make use of Medical Device Single Audit Program (MDSAP) audit reports when performing surveillance audits under Regulation 2017/745 Medical Devices Regulation (MDR) and Regulation 2017/746 In Vitro Diagnostic medical devices Regulation (IVDR). This guidance is of particular use when a manufacturer has undergone an MDSAP audit and wishes to present the audit report (including the associated attachments) in context of the regular surveillance audits performed in accordance with the MDR or IVDR. The use of MDSAP audit reports within the EU legislative framework is possible only where the MDSAP audit covers similar or equivalent MDR/IVDR requirements. When recent MDSAP audit reports are considered relevant then the scope and outputs of these reports could be taken into account as an input for developing surveillance audit programmes. This would potentially allow the notified body to focus their surveillance audit on specific MDR/IVDR requirements which are either not covered or only partially covered by the MDSAP audit report. Similarly, non-conformities identified in recent MDSAP audit reports can trigger the notified body to pay particular attention to those aspects in the MDR/IVDR planned surveillance audit.

MDSAP audit reports cannot be taken into account for initial quality management system audits required for the issuing of QMS certificates nor for unannounced audits under the MDR/IVDR.

What does this mean to you?

If your company undergoes MDSAP audits it could be worth investigating if your MDSAP audit covers similar or equivalent MDR/IVDR requirements. As MDCG 2020-14 recommends that notified bodies develop their own more detailed guidance for determining the extent to which MDR/IVDR quality management system requirements correlate to those covered in MDSAP audit reports, it could be of interest to discuss with your Notified Body if your MDSAP Audit Reports could be of use or not.

Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us


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