The Clinical Evaluation Report (CER) is a document that presents all the clinically relevant data collected for a particular device.
The Clinical Evaluation is a crucial element of a device’s conformity with the general safety and performance requirements (GSPR) of Annex I of the EU Medical Device Regulation 2017/745 (MDR), which should take into account the device’s normal conditions of its intended use and evaluate undesirable side-effects and the acceptability of the benefit-risk ratio (as referred to in Sections 1 and 8 of Annex I). In general, the basis and requirements for the Clinical Evaluation are laid down in Article 61 and Annex XIV of the MDR.
The Clinical Evaluation shall be planned in accordance with the requirements of Annex XIV Part A, and be recorded within a Clinical Evaluation Plan (CEP). Manufacturers should also have in place an updated Clinical Evaluation Procedure, as part of their Quality Management System (QMS), which shall provide an indication for the need of a CEP in order to comply with the MDR, as part of their technical documentation. The CEP shall take into account the intended purpose of the device, its indications and contraindications, description of the clinical benefit, and shall provide a Clinical Development Plan which outlines the progression from exploratory investigations to Post-Market Clinical Follow-up (PMCF).
Once these activities are performed, they shall be reported and analysed within the device’s Clinical Evaluation Report (CER), which is arguably the most important document within the technical documentation and which summarises and presents the clinical data collected to substantiate its claims of safety and performance against its claimed indications.
Even though some of the more simple and low-risk devices may not require clinical data to demonstrate conformity with the general safety and performance requirements (Article 61(10)) they must still have a Clinical Evaluation Plan and Report in place. The complexity of these documents will vary greatly depending on device risk, device type, and novelty. For higher risk devices, one would expect a greater collection and analysis of relevant clinical data, preferably obtained through clinical investigations.
Nevertheless, the CER will be expected to have a fixed structure. The MEDDEV 2.7/1 rev.4 guidance, released in 2016 for use in collaboration with the MDD, is still considered relevant and the state of the art with respect to laying out the overall format of the Plan and Report. Therefore, the backbone of each CER would not be expected to differ too much.
Although the requirements to draw up a CER have not changed significantly moving from the EU Medical Device Directive 93/42/EEC (MDD) to the MDR, there are higher expectations with respect to the quality of the content demonstrating the clinical safety and performance of the device. It is important that all claimed indications are backed up by sufficient clinical data and a robust PMCF Plan. Something to keep in mind is that the path down the Equivalence route has become more challenging under the MDR; unless you are the manufacturer of the predicate or draw up a contract with the manufacturer of the equivalent device to have access to their documentation, claiming equivalence may no longer be a viable option.
An understanding of Article 61, Annex XIV, as well as relevant MEDDEV and MDCG guidance documents will be paramount in meeting the requirements of the Clinical Evaluation and thus getting your product to market.
Advena specialises in the creation of Clinical Evaluation Plans and Reports for all device types, utilising our team of in-house and experienced consultants. The documents we create for you are state-of-the-art and are continuously being updated to reflect changes in interpretation, best-practice, and Notified Body expectations. Furthermore, you may wish to contract Advena to review your Clinical Evaluation prior to submission to a NB. Our review will highlight any deficiencies and also provide guidance in closing these gaps, all within one report.
Helpful Resources
MDCG 2020-13 Clinical evaluation assessment report template
MDCG 2020-5 Clinical Evaluation – Equivalence
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