To achieve and maintain CE Certification for a medical device as per MDR 2017/745 and authorization for sale in EU territory, every class Is, Im, Ir, IIa, IIb, III medical device must receive technical documentation approval along with clinical evaluation report (CER) approval from Notified Body.

MDR Clinical Evaluation referred in chapter VI of the new Medical Device Regulation 2017/745 Article 61(1) of the EU MDR indicates that manufacturers ‘shall plan, conduct and document a clinical evaluation’ to enable: Confirmation of conformity with relevant general safety and performance requirements … under the normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit-risk ratio … shall be based on clinical data providing sufficient clinical evidence

Article 2(48) implies that the purpose of the clinical evaluation is ‘to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer'

Here are a few key points to take into consideration while drafting a clinical evaluation report:

• While describing the device clearly indicate the intended purpose, including the intended patient population and medical conditions to be diagnosed, treated and/or monitored. Include a general description of the key functional elements: its parts/components (including software if appropriate), its formulation, its composition, its functionality and, where relevant, its qualitative and quantitative composition. The principles of operation of the device and its mode of action; explanation of any novel features.
• Clearly identify the associated clinical benefits of the device(s) as well as the conditions of use and specific contraindications, in a way that can be justifiably supported by sufficient clinical evidence
• the level of clinical evidence must be specified and justified by the manufacturer, taking the characteristics of the device and the intended purpose into account.
• To define the state of the art, describe the alternative available treatment options identified by the manufacturer which could offer comparable safety and performance for the same treatment indications / patient populations, etc.
• Identify benchmarks for safety and performance, based on aggregate data from several devices considered to have acceptable performance (e.g. systematic reviews or registry analysis); if individual devices are selected as benchmarks for safety and performance, a suitable rationale should be provided.
• Based on the benchmark, establish the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device
• While drawing conclusions take into consideration the completeness of the evidence to support: • all indications (including those implied by broad intended purpose statements) • all potential patient populations, with particular reference to high risk or vulnerable populations • all device variants and combinations • usage with accessories and other devices, where applicable • device lifetime in use • risk identification/confirmation of risks identified through the manufacturer's risk management processes • acceptability of residual risks

Key References to consider before developing your CER

1. Article 2(48), Article 61 (1) of EU MDR
2. MDCG Guidance 2020-6
3. MDCG Guidance 2020-13

Contact us for more information on how we can write higher quality CERs, faster

We assist our clients by preparing CER in line with article 61 and Annex XIV of MDR and MEDDEV 2.7/1 Rev 4. Our CER writers have significant experience in medical device industry, have detailed understanding of MDR and have successfully answered queries raised by the notified bodies.

• Pool of clinicians, PhDs, Postgraduates and Engineers
• Experience in drafting new reports and addressing NB comments
• 100+ documents drafted and approved through December 2023 (CER/CEP/SSCPs/PMS Plan/PMS Reports/PSURs/ PMCF Plan/ PMCF report)
• Excellent feedback from existing customers on deliverables

Our extensive writing capabilities also include the following

• End-to-end Clinical Evaluation Report /Clinical Evaluation Planning Writing and Consultation
• Literature Search and Review
• Response to Notified body's Questions