Clinical Evaluation ReportClinical Evaluation Report

A Clinical Evaluation Report (CER) is the document in which a manufacturer records the results of a clinical evaluation carried out under Article 61 of Regulation (EU) 2017/745, the Medical Device Regulation (MDR). Article 61(12) states that the clinical evaluation, its results, and the clinical evidence derived from it 'shall be documented in a clinical evaluation report as referred to in Section 4 of Annex XIV, which, except for custom-made devices, shall be part of the technical documentation referred to in Annex II.' The CER is therefore not a standalone regulatory filing; it is a required component of the technical documentation every device needs before a conformity assessment can be completed.

The clinical evaluation itself — the activity the CER documents — is defined by Article 61(1) as the process by which a manufacturer confirms conformity with the relevant general safety and performance requirements in Annex I 'under the normal conditions of the intended use of the device,' and evaluates undesirable side-effects and the acceptability of the device's benefit-risk ratio. That confirmation must be 'based on clinical data providing sufficient clinical evidence,' and the manufacturer must specify and justify the level of clinical evidence it considers necessary, appropriate to the device's characteristics and intended purpose.

A CER is not a one-time literature summary written to pass a notified body review and then filed away. Article 61(11) requires the clinical evaluation and its documentation to be 'updated throughout the life cycle of the device concerned' with data from the manufacturer's post-market clinical follow-up (PMCF) plan and its post-market surveillance plan. For class III devices and implantable devices, the PMCF evaluation report — and, where applicable, the summary of safety and clinical performance under Article 32 — must be updated with such data at least annually.

Article 61(3) sets out that a clinical evaluation 'shall follow a defined and methodologically sound procedure' based on three elements: a critical evaluation of relevant scientific literature currently available, where either the device itself or an equivalent device to which the literature relates is used and the data adequately demonstrate compliance with the general safety and performance requirements; a critical evaluation of the results of all available clinical investigations; and consideration of currently available alternative treatment options for the same purpose. Annex XIV Part A, Section 1 expands this into five activities a manufacturer must carry out to plan, conduct and document the evaluation: establishing and updating a clinical evaluation plan, identifying available clinical data and any evidence gaps through a systematic literature review, appraising the suitability of that data, generating new clinical data through properly designed investigations where gaps remain, and analysing all relevant data to reach conclusions on safety, clinical performance and clinical benefit.

Annex XIV Part A, Section 1(a) lists what the clinical evaluation plan itself must include at minimum: the general safety and performance requirements that need clinical-data support, a specification of the device's intended purpose, a clear specification of the intended target groups with indications and contra-indications, a description of intended clinical benefits with specified clinical outcome parameters, the methods to be used to examine clinical safety and determine residual risks and side-effects, the parameters to be used to judge the acceptability of the benefit-risk ratio, how benefit-risk issues relating to specific components (such as pharmaceutical substances or animal or human tissue) are addressed, and a clinical development plan showing progression from exploratory to confirmatory investigations and into PMCF, with milestones and acceptance criteria.

Annex XIV Part A, Section 2 requires the evaluation to be 'thorough and objective,' taking into account both favourable and unfavourable data, with depth and extent proportionate to the device's nature, classification, intended purpose and risks and to the manufacturer's claims. Section 4 ties the output back to the CER directly: the results of the clinical evaluation and the clinical evidence on which it is based must be documented in a clinical evaluation report that supports the conformity assessment, and both favourable and unfavourable data considered must be included in the technical documentation — a CER that cites only supportive literature and omits contrary findings does not meet this requirement.

Article 61(3)(a) and Annex XIV Part A, Section 3 allow a clinical evaluation to rely, in whole or in part, on clinical data relating to a different device if equivalence to the device under evaluation can be demonstrated. The Regulation sets out three categories of characteristics that must be considered: technical (similar design, conditions of use, specifications and properties, deployment method, principles of operation and critical performance requirements), biological (same materials or substances in contact with the same tissues or body fluids, for a similar duration and kind of contact, with similar release characteristics including degradation products and leachables), and clinical (same clinical condition or purpose, severity and stage of disease, site in the body, population, and similar critical performance for the intended clinical effect). The Regulation states the characteristics must be similar 'to the extent that there would be no clinically significant difference in the safety and clinical performance of the device,' and that equivalence claims must be based on proper scientific justification.

Annex XIV also requires that the manufacturer have 'sufficient levels of access to the data relating to devices with which they are claiming equivalence' to justify the claim — access to marketing literature is not sufficient; the manufacturer needs the underlying technical, biological and clinical data to make a reasoned comparison. MDCG 2020-5, Clinical Evaluation – Equivalence, A guide for manufacturers and notified bodies (April 2020), expands on the three characteristic categories with worked guidance and an equivalence-table template, and states that MEDDEV 2.7/1 Rev. 4 (the pre-MDR clinical evaluation guide) should still be used alongside it, while flagging that some MEDDEV requirements are not fully aligned with the MDR text.

Article 61(4) and (5) separately describe when a manufacturer may rely on a demonstrated equivalence to avoid performing a new clinical investigation for implantable and class III devices — including the case of a manufacturer relying on another company's already-marketed equivalent device, where a contract must give the second manufacturer 'full access to the technical documentation on an ongoing basis' and the original clinical evaluation must have been performed in compliance with the Regulation. Article 61(6) lists further exemptions, including specific device types such as sutures, staples, dental fillings and similar well-established products, where clinical evaluation can rely on sufficient clinical data and compliance with a relevant common specification rather than a new investigation.

Annex XIV Part B describes post-market clinical follow-up as 'a continuous process that updates the clinical evaluation referred to in Article 61 and Part A of this Annex,' to be addressed in the manufacturer's post-market surveillance plan. Section 5 states its purpose: proactively collecting and evaluating clinical data from use of the CE-marked device, to confirm safety and performance throughout its expected lifetime, ensure the continued acceptability of identified risks, and detect emerging risks from factual evidence. PMCF must follow a documented PMCF plan; Section 6.1 lists the aims that plan must serve — confirming safety and performance, identifying previously unknown side-effects and monitoring known ones, analysing emergent risks, confirming the benefit-risk ratio remains acceptable, and detecting systematic misuse or off-label use.

Section 6.2 sets minimum content for a PMCF plan: the general and specific methods to be used (gathering clinical experience, user feedback, literature screening, registries or PMCF studies), a rationale for choosing those methods, a reference to the relevant parts of the CER and to the risk management file, specific objectives, an evaluation of equivalent or similar device data, reference to relevant common specifications and standards, and a justified time schedule for PMCF activities. Section 7 requires the manufacturer to analyse PMCF findings and document the results in a PMCF evaluation report, which becomes part of both the CER and the technical documentation. Section 8 closes the loop: PMCF evaluation report conclusions must feed back into the clinical evaluation and into risk management, and if PMCF identifies a need for preventive or corrective measures, the manufacturer must implement them.

This structure is why a CER is described as 'living' rather than a fixed, point-in-time document: complaint trends, PMCF data and literature surveillance all have a defined route back into the CER's conclusions, and Article 61(11) sets an explicit annual update cadence for the PMCF evaluation report (and related summary of safety and clinical performance) for class III and implantable devices specifically — the Regulation does not state a fixed update interval for the CER itself for other device classes, leaving the update frequency to be set by the manufacturer's clinical evaluation plan and post-market surveillance plan, proportionate to risk.

Article 61(12) places the CER inside Annex II technical documentation for every device except custom-made devices. Annex II requires technical documentation to be presented 'in a clear, organised, readily searchable and unambiguous manner' and to include device description and specification, design and manufacturing information, the general safety and performance requirements, benefit-risk analysis and risk management, product verification and validation, and — per Article 61(12) — the clinical evaluation report itself. A notified body reviewing technical documentation for a class IIa, IIb or III device under the relevant conformity assessment Annex therefore reviews the CER as part of that file, not as a separate submission.

The clinical evaluation process is also a required element of the manufacturer's quality management system. MDR Article 10(9) lists the elements a manufacturer's QMS must address, and the clinical evaluation process — planning, conducting and documenting a clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF — is one of the listed elements, alongside risk management and post-market surveillance. This means the CER's existence, update triggers and review are expected to run through a procedure within the QMS, not as an ad-hoc document produced only when a conformity assessment is due; the QMS procedure is what is meant to ensure PMCF and complaint signals actually reach the CER on a defined basis.

Because the CER sits inside both the technical documentation and the QMS clinical evaluation process, keeping its underlying inputs — the literature search strategy and results, the equivalence justification and access-to-data evidence, clinical investigation reports, PMCF plan and PMCF evaluation reports, and the risk management file it cross-references — traceable to the current CER version is what lets an update be a focused revision rather than a full rebuild each time a conformity assessment or periodic safety update is due. Generic record-keeping practice such as linking a literature search, a PMCF report and a CER revision date is a documentation discipline; it is not itself a clinical or regulatory judgment, which must remain with the manufacturer's qualified clinical evaluation personnel.