The MDCG issued MDCG 2020 -13 guidance for notified bodies (NB) specifying a template to be used during auditing the clinical evaluation (CER) of manufacturers. Although the guidance document is intended for the NB’s, manufacturers can benefit from it during preparation of the clinical evaluation report template.

CER is a core requirement of the Medical Device Regulation EU 2017/745 (MDR) and must be part of the manufacturer’s quality management system. As summarized in our “How to CE mark your medical device” article, the technical documentation shall include clinical evaluation as required by Article 61 and is an important part. This guidance document (MDCG 2020 -13) gives an overview of MDR Annex IX Chapter II and specifies 9 main sections listed below as the minimum content.

A clinical evaluation assessment report (CEAR) template;

  • Section A: Administrative particulars (notified body, manufacturer, product and clinical evaluation report reference)
  • Section B: Reviewers involved in the notified body assessment of the clinical evaluation
  • Section C: Device description, classification, clinical evaluation plan, information materials supplied by the manufacturer, common specifications and harmonised standards applied, equivalence and state of the art
  • Section D: Clinical literature review
  • Section E: Clinical investigations and related documentation
  • Section F: PMS, PMCF and the plan for updates
  • Section G: IFU, SSCP, labelling and other information supplied with the device
  • Section H: Summary of all available data and conclusions
  • Overall Conclusions

How to prepare a good clinical evaluation report template? 

So, as a manufacturer you may think of including all details listed on Sections C to H into your clinical evaluation report template. This will at least prevent structural first round questions during your technical documentation review.

In addition to the above sections the MDCG 2020 -13 specifies two headers as specific consideration which might be very useful for certain type medical device manufacturers.

  • Section I: Clinical evaluation consultation procedure for certain class III and class IIb devices (Article 54)
  • Section J: Where demonstration of conformity based on clinical data is not deemed appropriate (Article 61(10))

If you need further information about preparation of a clinical evaluation report (CER) and CE marking of your medical device do not hesitate to contact us. Our experts will be happy to help you.

Share on linkedin
LinkedIn
Share on email
Email

How can we help you?

If you need more information, we will be glad to have a chat