Notified Body Review Process of CER
The evaluation of clinical evaluation reports and their supporting data by a notified body is mandatory in the CE marking approval process for all medical devices in the European Union. The frequency and duration of the review will be based on the risk posed by the device and the conformity assessment procedure that is established.
Notified Bodies are independent organizations assigned by EU member states to evaluate the conformity of medical devices with the applicable regulations. It is applicable for medical devices in accordance with Directive 93/42/EEC. An outline of the standard procedure for a Notified Body to review CER documents is provided below
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Review Process of CER
The manufacturer of a medical device submits the Clinical Evaluation Report (CER) to the Notified Body, detailing its clinical evaluation, safety, and performance data. The Notified Body thoroughly reviews the Clinical Evaluation Report (CER), assessing its structure, content, and regulatory compliance, as per Directive 90/385/EEC, and the manufacturer’s procedures, PMS, PMCF plans, and device conformity.
Directive 90/385/EEC mandates active implantable medical devices to undergo a design or type examination dossier assessment, assessing data validity, manufacturer’s conclusions, and device conformity to essential requirements.
The Notified Body may engage experts with clinical and technical expertise to assist in the evaluation process, providing insights into the device’s clinical data and regulatory compliance.
- The Notified Body conducts a crucial benefit-risk assessment to evaluate a device’s effectiveness by determining if its benefits outweigh the identified risks.
- The Notified Body assesses the manufacturer’s risk management process, ensuring it’s suitable for the device’s intended use and evaluating the effectiveness of risk mitigation measures.
- The Notified Body verifies the CER’s regulatory compliance by ensuring it contains all necessary information, including clinical data, device descriptions, intended use, and labelling.
- The body must evaluate clinical data from equivalent devices, assess the manufacturer’s access, and consider current knowledge for hazard identification and benefit/risk profile assessment, considering commercially sensitive information.
- The Notified Body reviews the CER to assess device compliance with regulations, and if deficiencies are identified, it may request additional information or corrective actions from the manufacturer.
- The Notified Body reviews and interacts with the manufacturer to determine the device’s compliance with regulations, potentially issuing a CE certificate if it meets the requirements.
- The manufacturer is obligated to conduct post-market surveillance activities and report to the Notified Body if the device is granted CE marking.
- The notified body must create a Clinical Evaluation Assessment Report (CEAR) based on the submitted report and supporting documentation, addressing the manufacturer’s application, device description, purpose, classification, risk analysis, clinical investigation plans, authors, equivalence assessment, and device conformance.
The European Union’s medical device review process based on device classification requires manufacturers to collaborate with the Notified Body, update clinical evaluation reports, and consult guidance from the Notified Body Operations Group for efficient review.
Notified bodies must document procedures for reviewing clinical evaluation reports, EC design-examination and EC type-examination certificates, and manufacturers’ updates, referencing guidance and checklists from the Notified Body Operations Group.