In July 2020, the European Commission’s Medical Devices Coordination Group (MDCG) published a guidance document that endorses an annotated and harmonized clinical evaluation assessment report (CEAR) template that Notified Bodies must use to document their review of the clinical evidence presented by manufacturers that want to place their medical devices on the EU market. The CEAR is a key requirement of the EU Medical Devices Regulation (MDR). The CEAR template sets out the minimum content that the Notified Body must include in the CEAR, giving a useful comparing tool for manufacturers.
Manufacturers of medical devices seeking to obtain a CE certificate to place their medical devices on the EU market must present clinical evidence in a clinical evaluation report (CER) and conduct the related clinical evaluation. As part of the conformity assessment procedure under the MDR, Notified Bodies must assess such clinical evidence and the related clinical evaluation that was conducted and clearly document the conclusions of their assessment in a CEAR.
The CEAR template allows a standardized approach to the clinical evaluation assessment, aiming to ensure a harmonized review by Notified Bodies. One could hope that the CEAR template will help ensure a more level playing field for manufacturers of medical devices placed on the EU market. If used consistently and correctly by Notified Bodies, the CEAR template could serve as a tool by regulatory authorities and Notified Bodies to compare the relevant information on which Notified Bodies base their clinical evaluation assessments. This may particularly be relevant for comparable medical devices whose assessments — by experience — often receive vastly different assessments by the Notified Bodies.
With the new annotated and harmonized CEAR template, the MDCG aims to introduce a much-needed standardized method for documenting Notified Bodies’ assessment of manufacturers’ clinical evaluation and related documents. The assessment of clinical evidence includes, among others,
- assessing the suitability of using data from claimed equivalent devices
- verifying that the clinical evidence and the clinical evaluation are adequate
- verifying the manufacturer’s conclusions on the conformity with the relevant general safety and performance requirements
- considering the clinical evaluation and the benefit-risk determination
The CEAR template covers the minimum content needed for the evaluation procedure, but the reviewing Notified Body may need to supplement the template with information. The CEAR template is divided into 11 sections, some of which apply generally, while others depend on the medical device being assessed.
Non-compliances Established During the Assessment
In case of non-compliances identified by Notified Bodies during their clinical evaluation assessment, manufacturers of medical devices must undertake follow-up actions to close these non-compliances.
If there are still one or more open minor non-compliances at the conclusion of the clinical evaluation assessment, the Notified Body must clearly describe them in the final CEAR and must recommend appropriate follow-up actions and expected completion timelines to be followed under its supervision.
Expert Panel Review
The CEAR template is particularly important for class III implantable devices and class IIb active devices intended to administer and/or remove a medicinal product that may be subject to an expert panel clinical evaluation consultation procedure under the MDR.
Because the expert panels may not have access to the full conformity assessment for the medical device, they will often have to rely on the CEAR. The guidance document therefore provides that the CEAR must contain sufficient information regarding the manufacturer’s clinical evidence, in particular concerning (i) the benefit-risk determination and (ii) the consistency of that clinical evidence with the intended purpose of the medical device, including the medical indication(s). The guidance document also adds that expert panels may request access to the Notified Bodies’ conclusions on the CEAR.
The CEAR template is important due to the increased focus on the clinical evaluation of medical devices introduced by the MDR. Hopefully the CEAR template will serve as a tool to give manufacturers of medical devices a much-needed harmonized approach to Notified Bodies’ clinical evaluation assessment.
Sidley Austin LLP provides this information as a service to clients and other friends for educational purposes only. It should not be construed or relied on as legal advice or to create a lawyer-client relationship. Readers should not act upon this information without seeking advice from professional advisers.
Attorney Advertising—Sidley Austin LLP, One South Dearborn, Chicago, IL 60603. +1 312 853 7000. Sidley and Sidley Austin refer to Sidley Austin LLP and affiliated partnerships, as explained at www.sidley.com/disclaimer.
© Sidley Austin LLP