The clinical evaluation of medical devices is an important activity carried out by manufacturers to demonstrate device safety and performance to notified the Body of the claimed intended use. This is demonstrated through clinical literature, clinical experience data, and information gathered from the clinical trial(s). The below content provides technical guidance to registration applicants for conducting medical device clinical evaluation and successfully documenting it.
Clinical Evaluation of Medical Device
Clinical Evaluation Report
The Clinical Evaluation Report contains the clinical evaluation results and the clinical evidence on which it is based to support the assessment of the device’s conformity. To obtain CE marking in the European Union, all device manufacturers must prove their devices meet the general safety and performance requirements (GSPR) per Annex I of the MDR? to comply; 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 ongoing process conducted throughout the life cycle 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, and 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, available data, all assumptions made, and all conclusions reached.
Based on the risk category of the device, the Clinical Evaluation Report 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 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.
MDR Article 61 and MEDDEV 2.7.1 Rev 4
MDR article 61- section 12 and Annex XIV – Part A- section 4 states the requirement of a CER. The clinical evidence from the clinical evaluation will be documented in the CER. It shall be a part of the technical documentation that will support assessing the device’s conformity.
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 CER.
As per this guidance, the CER should contain enough information to be read and understood by an independent party such as a regulatory authority or notified body. Thus, it should provide enough detail for understanding the search criteria adopted by the evaluators, data that are available, all assumptions made, and all conclusions reached.
Role of Consultants and Writers
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 of chief importance for the official approval process for CE marking and marketing in Europe and the continuing market surveillance in medical devices, improving safety and performance.
We support worldwide clients in evaluating 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).
Clinical Evaluation Report Conclusion
The Clinical evaluation report conclusions should have a clear statement concerning compliance with general safety and performance requirements.
It should address the following.
- The acceptability of the benefit/risk profile according to current knowledge or state of the art in the medical fields concerned and according to available medical alternatives.
- Suitability of information materials supplied by the manufacturer, if the intended purpose and risk reduction measures are adequate; discrepancies.
- Adequacy of the device, including its IFU, for the intended users and usability aspects; discrepancies.
- Basis of manufacturer claims and level of acceptance.
- 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 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.
CER Review by Notified Body
Notified Body review is mandatory for CE marking. NB audit the QMS and review the submitted CER (As an annex to Technical Documentation) with supporting documents for conformity assessment of a device with relevant Essential Requirements (as per MDD, MDR, and IVDR) and prepare a Clinical Evaluation Assessment Report (CEAR) based on review conclusions.
NB asks the manufacturer for more data and justification until satisfied for CE marking in case of dissatisfaction.
The timing and the frequency of the notified body reviews will vary depending on:
- Device usage and associated risk;
- How well-established the device is; and
- CE conformity assessment applied.
CER Annual Updates
Many manufacturers assume that the Clinical Evaluation is done only once. Still, the reality is that the activities of Post Market Surveillance, Post Market Clinical Follow Up if applicable, Periodic Safety Update Report and Vigilance need to be continuously updated in CER. Any noticeable changes against the previous data should be recorded, and Clinical Evaluation Report should be updated accordingly.
During the post-market phase, in order to update their CER, the manufacturer should actively collect information from post-market experiences with their devices. Based on a PMS plan, the manufacturer should establish a comprehensive PMS system under its QMS.
Based on a PMS plan, the manufacturer should establish a comprehensive PMS system under its QMS. During the post-market phase, to update the Clinical Evaluation Report, the sales team or field team should take user information based on their experience.
Data collected through the Post Market Surveillance and conclusions be added on to relevant part of the CER and should also serve the purpose of transparency. Similarly, based on the PSUR update, the CER must also be updated annually or for at least two years.
Furthermore, no matter your device risk class or type of device, we can conduct CER documentation keeping all NB requirements. Please write to us for more information.
Expected time taken by a Notified Body to review the Clinical Evaluation Report?
Time taken by the notified Body to review Clinical Evaluation Report depends on the technical file and number of devices included in the file. Generally CER is reviewed along with other parts of the technical file by an additional clinical expert. 2-3 months is the normal timeline.
Explain "external experts"
External Clinical Experts are clinical professionals with expertise in the subject device who are selected and trained by the Notified Body (NB) for clinical evaluation assessment and provide advice to the NB on regulations, guidance, common specifications, and harmonized standards.
How equivalent device justification to avoid further clinical investigation
It is practically impossible to conduct an investigation due to cost and legal requirements, but it is critical that the device be clinically proven to be safe and effective. If an equivalent US FDA or EU-approved device is available on the market, it can be used to demonstrate device safety and effectiveness in terms of technical, clinical, and biological parameters. Equivalent device data is also appraised, analyzed, and recorded, adding more value to CERs.