What is a Clinical Evaluation Report (CER)?
A Clinical Evaluation Report (CER) thus contains the results of clinical evaluation and the clinical evidence on which it is based, which will support the assessment of the conformity of the device.
Do you know before obtaining CE marking in the European Union, the medical device manufacturers must prove that their devices meet the general safety and performance requirements (GSPR) per Annex I of the MDR?
In order to satisfy these requirements, the medical device manufactures must conduct Clinical Evaluation per Article 61 and Annex XIV of the MDR, including Post Market Clinical Follow-up [PMCF].
Clinical Evaluation is a continuous or on-going process conducted throughout the life cycle of a product based on a comprehensive analysis of available pre-and post-market clinical data relevant to the intended use of the device in question, including clinical performance data and safety data from PMS, PMCF or clinical investigation.
This includes data specific to the product in question as well as any data relating to devices claimed as equivalent by the manufacturer.
It contains enough information to be read and understood by an independent party like a regulatory authority or a notified body. Hence, it provides sufficient details for understanding the search criteria adopted, data that are available, all assumptions made, and all conclusions reached.
Based on the risk category of the device, the CER can be fairly simple or quite extensive. The CER is a major portion of the technical file even though it is a stand-alone document and it is required for all medical devices regardless of classification.
It provides evidence that the device has undergone rigorous evaluation or in many cases compared to research done for other substantially equivalent devices already on the market.
Clinical Evaluation Report Regulation and Guidance!
MDR article 61- section 12 and Annex XIV – Part A- section 4 states about the requirement of a Clinical Evaluation Report. The clinical evidence from the clinical evaluation will be documented in the CER and it shall be a part of the technical documentation which will support the assessment of the conformity of the device.
Meddev 2.7/1 Rev.4 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC, is the guidance document for Clinical Evaluation, and Stage 4 states about the requirement of a Clinical Evaluation Report.
As per this guidance, the CER should contain enough information to be read and understood by an independent party such as regulatory authority or notified body. It should thus provide enough detail for understanding the search criteria adopted by the evaluators, data that are available, all assumptions made, and all conclusions reached.
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How we assist and what assurance we provide?
We assist in preparing Clinical Evaluation Reports for your products by applying article 61 and Annex XIV of MDR and MEDDEV 2.7/1 Rev 4.
The clinical data evaluation is not only of chief importance for the official approval process for CE marking and marketing in Europe but also for the continuing market surveillance in the field of medical devices, improving safety and performance.
We support worldwide clients in the evaluation of clinical data documented as Clinical Evaluation Reports along with related documents which are part of the technical documentation, followed by assisting with submission to the notified body as part of the official conformity process for your medical device(s).
It should address:
- The acceptability of the benefit/risk profile according to current knowledge or the state of the art in the medical fields concerned and according to available medical alternatives.
- Adequacy of the information materials supplied by the manufacturer, if the intended purpose and risk reduction measures are adequate; discrepancies
- Suitability of the device, including its IFU, for the intended users and usability aspects; discrepancies.
- Level of acceptance with manufacturer claims and foreseen discrepancies.
- If there is constancy between the clinical data, the information materials supplied by the manufacturer, the risk management documentation or the RMF for the device under evaluation; discrepancies.
- If there is constancy between these documents and the current knowledge or the state of the art; discrepancies.
- Unanswered questions or uncertainties derived during risk benefit analysis and acceptance during Post Market Studies.
- Application of above in line with current PMS and PMCF studies.
- If new or additional PMS activities, including PMCF studies, should be foreseen.
Important facts about MDR CER
Notified Body Review of Clinical Evaluation Report
The notified body has an important role in the assessment and verification of the CER and supporting documentation provided by the manufacturers to support the demonstration of conformity of a product with the general safety and performance requirements of Annex I of MDR.
The timing and the frequency of the notified body reviews will vary depending on:
- The risk carried by the device;
- How well-established the device is; and
- The conformity assessment applied.
Clinical Evaluation Report (CER) annual update
Many manufacturers assume that the CER is done only once but the fact is that it needs to be continually updated per Post Market Surveillance [PMS] and PMCF or Periodic Safety Update Report [PSUR] or Vigilance activities.
Any notable changes that impact the initial data collection should be recorded and the CER must be appended accordingly.
During post-market phase, the manufacturer should actively gather information from the post-market experience with their devices in order to update their CER.
The manufacturer should establish a comprehensive PMS system under its QMS based on a PMS plan.
Relevant data gathered through PMS should be used to update any relevant part of the CER and should also serve the purpose of transparency. Similarly, based on the update of the PSUR, annually or at least two years, the CER also must be updated.
CLINICAL EVALUATION REPORT CONTENTS
- Scope of the Clinical Evaluation
- General Details (Manufacturer Name & Address, Responsible Person)
- Device Details (Description, Name, Models, Variants, Intended Purpose, Risk Class, CE marking status, Contraindications, Warnings, Precautions, Identification of Changes from previous version –if already in market)
- Clinical Background, Current Knowledge, State Of Art
- Device under Evaluation (Type of Evaluation -Based on available scientific literature’s, Clinical investigations etc)
- Demonstration of Equivalence (If equivalency is claimed)
- Identification of Pertinent Data (literature’s, Clinical investigations, PMS, PMCF data)
- Data Generated and Held by the Manufacturer (PMS and its Outcome, PMCF and its Outcome, Pre-Clinical Studies, Bio-compatibility Testing, Bench Testing, Electrical Safety, Software Verification & Validation, Scientific Literature’s data
- Summary and Appraisal of Clinical Data
- Analysis of Clinical Data (Based on Safety, Acceptable Benefit/Risk Profile, Performance, Acceptability of Side-Effects)
- CER Conclusion
- Qualification of the Responsible Evaluators
- Date of Next Clinical Evaluation