Newsletter No 37 September 2023
Subject: Clinical evaluation in the context of the MDR
MDR has introduced substantial changes for the assessment and monitoring of medical devices throughout their lifecycle. One of the impacted processes that raised standards under the MDR is the clinical evaluation, which is one of the pillars to obtaining and maintaining the EC certificate of conformity.
What is the clinical evaluation of a medical device under MDR?
The clinical evaluation is a systematic and planned process to continuously generate, collect, analyze and assess the clinical data pertaining to a device to verify the safety and performance, including clinical benefits of the device when used under the normal conditions of the intended use of the device established by the manufacturer.
The clinical evaluation also aims assessing the undesirable side-effects and acceptability of the benefit-risk ratio. Under MDR, there is a higher focus on the link of the clinical evaluation with the risk management and post-market surveillance.
The clinical evaluation shall be based on clinical data providing sufficient clinical evidence to demonstrate conformity with the relevant general safety and performance requirements. The level of clinical evidence shall be specified and justified by the manufacturer and reviewed by the Notified Body for EC-certified devices.
It is required for all devices from class I to III, both new and legacy devices. It is not required for procedure packs, as the clinical evaluation is assessed for the single devices included in a procedure pack.
Who is performing the clinical evaluation?
The person responsible for the clinical evaluation must have appropriate qualification and knowledge, in terms of medical and regulatory knowledge, knowledge of device use, and experience with scientific literature review. Requirements include a relevant higher education degree and sufficient professional experience. A declaration of interest is also required.
What documents conform a clinical evaluation?
The clinical evaluation is performed according to a Clinical Evaluation Plan (CEP) prepared for each device family. The plan includes all the actions assessed as required, and references to the determinations for the actions assessed as not required, such as post-market clinical follow-up actions or clinical investigations.
Once all actions have been performed, the clinical evaluation report (CER) for each device family is prepared to summarize and assess the data collected. The conclusions are used to assess the benefit-risk from a clinical perspective.
Which is the role of the distributors?
The distributors play a key role providing information from the market regarding customer feedback, complaints and PMS data upon request from the manufacturer. All data provided from the distribution chain are collected by the manufacturer and used when relevant for the clinical evaluation.
This newsletter is part of our campaign to increase the sensitivity and the awareness of all our business partners, to bring more clarity around the MDR journey and challenges and opportunities around the MDR Art.22 “Systems and Procedure Packs”.
We are already today all dependent on efficient cooperation. For the MDR implementation, we require even closer collaboration to ensure we all can deliver safe supplies to hospitals and patients in the future.
We are confident we will continue to supply health care competently on customized surgical procedure sets and small kits.
Do you wish to know more about specific MDR topics? Do you have any questions or comments about STS newsletter? Write us at MDR2020@stsmedicalgroup.com.
The next MDR newsletter will be issued in October. We wish everyone a pleasant month.
CEO STS Medical Group
Group Manager Regulatory Affairs
STS Medical Group