What is a Clinical Evaluation Report (CER)?
A Clinical Evaluation Report (CER) contains the clinical evaluation process and is required for all medical device classes in Europe. The CER is a standalone document comprising the analysis of inputs from risk management, claims, post-market surveillance, validation, and verification testing, literature review, and clinical investigations. The overall objective of the CER is to determine whether there is sufficient clinical evidence to confirm the safety and performance of the medical device, based on the intended use and claims made by the manufacturer.
The latest requirements from EU MDR clinical evaluation are extensive and the strategy to achieve conformity is not straight forward. The interpretation of the standard is evolving and there are conflicting opinions and interpretations which may lead to delayed decision making. To show conformity with general requirements in terms of safety and performance under normal use of the product, the manufacturer must create a clinical evaluation. This clinical evaluation needs to be planned, and documented, as a report contained in the technical documentation. It must be based in accordance with the requirements set out in Article 61 and Annex XIV of European Medical Device Regulation 2017/745.
Initial and update MDR CER
The initial CER is created during the development phase of your device and is a prerequisite for obtaining European market approval. Regular aftermarket release updates are required to reflect data from post-market surveillance, PMCF, newly discovered risks or indications, and developments in the clinical file and publications.
Requirements of EU MDR CEP
- Specification of the intended purpose of the device
- Clear specification of intended target groups with clear indications and contra-indications
- Identification of the general safety and performance requirements that require support from clinical data
- A detailed description of intended clinical benefits to patients with relevant clinical outcome parameters
- Specification of methods to be used for examination of qualitative and quantitative aspects of clinical safety with clear reference to the determination of residual risks and side effects
- Indicative list and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device
- Indication how benefit-risk issues relating to specific components such as the use of pharmaceutical, non-viable animal, or human tissues, are to be addressed
- Clinical development plan indicating a progression from exploratory investigations, such as first-in-man studies, pilot studies, to confirmatory investigations, such as pivotal clinical investigations, and a PMCF with an indication of milestones and a description of potential acceptance criteria
Our service offerings
New/update CER and CEP
GAP-analysis of your current CER
CEP / CER Training
Additional requirements in CER
New/update CER and CEP
- Preparing a new CEP and CER
- Transition to MDR from MDD
- Update to the CEP and CER
- Literature search for safety & performance, State of The Art (SOA), and clinical guidelines
- Prepare CER per TGA, Australia
GAP-analysis of your current CER
- Identify gaps in your existing CER
- Assistance in equivalence establishment
- Review of state of art section
- Analysis of the device claims
CEP / CER Training
- Create procedures and templates for MDR CER
- Provide training on the new procedures
- Prepare the core team for a detailed notified body audit
Additional requirements in CER
- Increased PMS: Both MEDDEV 2.7/1 Rev 4 (Section 4) and MDR (Article 2 (48)) state that clinical data should be sourced through traditional methods and post-market surveillance, in particular, the post-market clinical follow-up (PMCF)
- Clinical Evaluation Plan: Content includes identification of the general safety and performance requirements that require support from relevant clinical data
- Equivalence: Technical, biological, and clinical characteristics should be similar, and manufacturers must have sufficient levels of access to data to justify claims of equivalence
- Claim Matrix: Establish claim matrix with endpoints and justified with the design validation and/or clinical outcomes
- General Safety and Performance Requirements (GSPR): Address all relevant GSPR according to the device under evaluation
