Clinical Evaluation Report
The clinical evaluation of medical devices is a crucial activity undertaken by producers in order to demonstrate device safety and performance in order to notify the Body of the stated intended use. Clinical literature, clinical experience data, and information gained from the clinical trial all support this (s). The following content provides technical guidance to registration applicants on how to conduct and document a clinical evaluation of a medical device.
What Is Clinical Evaluation Report
The Clinical Evaluation Report (CER) provides the clinical evaluation results as well as the clinical data that supports the device’s conformity assessment. To get CE marking in the European Union, all device makers must demonstrate that their products fulfil the MDR’s Annex I’s general safety and performance criteria (GSPR). Medical device manufacturers must perform Clinical Evaluation in accordance with Article 61 and Annex XIV of the MDR, as well as Post Market Clinical Follow-up [PMCF].
Medical Device 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.
The Clinical Evaluation Report might be basic or detailed, depending on the device’s risk categorization. Despite being a stand-alone document, the CER is an important part of the technical file and is required for all medical devices, regardless of classification. It shows that the gadget has been rigorously evaluated or, in many cases, compared to research done for other substantially similar products that are currently 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 Clinical Evaluation Report. 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 Clinical Evaluation Report 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 clinical evaluation report (As an annexe 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 believe that the clinical evaluation of a medical device is completed only once. Nonetheless, the actions of Post Market Surveillance, Post Market Clinical Follow Up (if appropriate), Periodic Safety Update Report, and Vigilance must all be updated in CER on a regular basis. Any significant differences from previous data should be noted, and the Clinical Evaluation Report should be revised as needed.
During the post-market phase, the manufacturer should actively collect information from post-market experiences with their gadgets in order to update their CER. The manufacturer should implement a comprehensive PMS system under its QMS based on a PMS plan.
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.
The length of time it takes the notified body to review the Clinical Evaluation Report is determined by the technical file and the number of devices in the file. An additional clinical expert usually reviews CER along with other aspects of the technical material. The typical timeline is two to three months.
External Clinical Experts are clinical practitioners with experience in the subject device who are chosen and trained by the Notified Body (NB) for clinical evaluation assessment and provide advise on rules, guidance, common specifications, and harmonized standards to the NB.
Due to expense and regulatory constraints, conducting an investigation is almost impossible, but it is vital that the device be clinically demonstrated to be safe and effective. If an analogous FDA-approved device in the United States or the European Union is available, it can be utilised to show device safety and effectiveness in terms of technical, clinical, and biological aspects. Equivalent device data is also evaluated, documented, and rated, giving CERs even more worth.