MDR Clinical Evaluation Reports for Lower-Risk Class Devices 

It is known that the main objective of the implementation of the MDR was to strengthen the regulatory framework for medical devices to further ensure a high level of safety and performance of medical devices sold in the EU.  

Conducting MDR clinical evaluation reports

Based upon the general obligations as included in Article 10 (3) of the MDR, all manufacturers shall conduct a clinical evaluation under the requirements set out in Article 61 and Annex XIV, including a PMCF. Where clinical evaluation(1) is defined as “a systematic and planned process to continuously generate, collect, analyze and assess the MDR clinical data pertaining to a device to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.”  

The clinical data(2) to be collected, analyzed, and assessed as part of this MDR clinical evaluation is defined as information concerning safety or performance that is generated from the use of a device and is sourced from the following:  

• • clinical investigation(s) of the device concerned,  
  • clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated,  
  • reports published in peer-reviewed scientific literature on other clinical experiences of either the device in question or a device for which equivalence to the device in question can be demonstrated,  
  • clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up. 

Sources of this clinical data can originate from pre- and post-market clinical data where it is noted that there is a clear difference in the level of clinical evidence obtained from these data sources. Although not specifically included in a general guidance, the Medical Device Coordination Group provided a suggested hierarchy for the level of MDR clinical evidence originating from these data sources as part of MDCG 2020-6 “Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC”. This hierarchy is included below and ranks sources of clinical data from strongest to weakest to support compliance with the general safety and performance requirements.  

Despite the general obligation to prepare a MDR clinical evaluation, based upon technical file reviews, MedEnvoy has noted that a number of our customers, and more specifically Class I, self-declared customers, submit to us their position that they don’t require a Clinical Evaluation Report (CER) based upon article 61(10).   

Ensuring a MDR clinical evaluation plan

Therefore, to prevent delay in clearance for placing a device on the market, all manufacturers should ensure that a clinical evaluation plan and report are provided with the documentation for the completeness review of technical files. As a guidance document on input regarding data sources, which can be used from a Post-Market surveillance perspective reference, is made to the ISO/TR 20416 Technical Report on Post-Market surveillance for manufacturers.

Learn more with MedEnvoy

Manufacturers who need assistance with their MDR Clinical Evaluation Plan and/or MDR Clinical Evaluation Report can also reach out to MedEnvoy for additional support.

Learn more about clinical evaluations

• • Understanding Clinical Performance Reports(CPR) under the IVDR: A Guide for IVD Manufacturers