Clinical evaluation is a continuous procedure that happens at every stage of a medical device’s life cycle. It is typically carried out initially in the course of developing a medical device to determine what data must be produced to gain access to the market.
The first CE-marking must include a clinical evaluation, and it must be regularly updated going forward.
Clinical evaluation is essential and significant because it guarantees that assessments of the device’s performance and safety are grounded on adequate clinical evidence on the market.
Through this continuous procedure, manufacturers can give notified bodies and appropriate authorities enough clinical evidence to show that the device complies with the Essential Requirements for its life.
To support the evidence of a product’s compliance with the Essential Requirements of the applicable Directive, medical device manufacturers produce clinical evaluation reports and accompanying documentation, which the notified body evaluates and verifies.
Appendix A12 (Activities of Notified Bodies) contains comprehensive suggestions for notified bodies. These consist of:
- Advice for notified bodies regarding the evaluation of clinical assessment reports that manufacturers of medical devices supply as part of technical documentation (such as design dossiers); and
- advice for notified bodies regarding the creation of internal protocols for the evaluation of clinical aspects associated with medical devices.
Furthermore, referring to the Notified Bodies Operations Group (NBOG) papers is recommended. Checklists, forms, and best practice recommendations are all included in NBOG documents.
Under the European Medical Device Regulation (MDR), notified bodies play a crucial role in assessing the conformity of medical devices before they can be placed on the market. The EU MDR (Medical Device Regulation) is a regulatory framework governing medical devices within the European Union.
It aims to ensure the safety and performance of such devices while enhancing transparency and traceability throughout the supply chain.
Notified bodies are organizations designated by EU member states and authorized by the European Commission to conduct conformity assessments of medical devices.
Their main responsibility is to evaluate whether medical devices meet the requirements set forth in the EU MDR and comply with relevant harmonized standards.
Role in Assessing Clinical Evaluation Reports (CERs) under the EU MDR
Here’s an overview of their role in assessing CERs under the EU MDR:
1. Reviewing Clinical Evaluation Reports (CERs)
Notified bodies are responsible for reviewing the Clinical Evaluation Reports submitted by medical device manufacturers. These reports are essential documents that demonstrate the safety and performance of the medical device based on clinical data and literature review.
Overall, notified bodies play a critical role in ensuring the quality, reliability, and compliance of Clinical Evaluation Reports under the EU MDR, thereby contributing to the safety and effectiveness of medical devices marketed within the European Union.
2. Assessing Compliance with Regulatory Requirements
Notified bodies assess whether the CERs comply with the requirements outlined in the EU MDR. This includes verifying that the clinical data presented in the CERs are relevant, valid, and sufficient to demonstrate the safety and performance of the medical device throughout its lifecycle.
3. Verification of Clinical Data
Notified bodies verify the integrity and reliability of the clinical data presented in the CERs. They assess whether the data sources used in the clinical evaluation are appropriate and whether the analysis and conclusions drawn from the data are scientifically sound.
4. Assessing clinical evidence
Notified bodies employ experts with the necessary clinical, scientific, and technical expertise to evaluate CERs effectively. These experts assess the clinical evidence presented in the reports to ensure it supports the medical device’s intended purpose and claims.
5. Post-Market Surveillance
Notified bodies also play a role in post-market surveillance activities related to clinical data. They may review post-market clinical follow-up data and reports to ensure ongoing compliance with regulatory requirements and to assess the continued safety and performance of the medical device.
6. Interaction with Competent Authorities
Notified bodies collaborate with competent authorities, such as national regulatory agencies, to ensure consistency in the assessment of CERs and to address any concerns or issues that may arise during the evaluation process.
7. Granting of CE Marking:
Based on their assessment of the CERs and other conformity assessment activities, notified bodies to determine whether a medical device meets the requirements for CE marking.
CE marking indicates that the device complies with the applicable regulatory requirements and can be placed on the market within the European Union.
Under the European Medical Device Regulation (EU MDR), notified bodies are designated organizations responsible for assessing the conformity of medical devices with regulatory requirements before they can be placed on the market or put into service within the European Union.
Several Criteria and Obligations of Notified Bodies
To meet the EU MDR requirements, notified bodies must adhere to several criteria and obligations.
1. Designation and Accreditation
Notified bodies must be designated by a Member State and accredited to conduct conformity assessments of medical devices according to the requirements of the EU MDR.
They must demonstrate compliance with ISO/IEC 17000 series standards for conformity assessment.
2. Technical Competence
Notified bodies must possess and maintain the necessary technical expertise and competence to assess the conformity of medical devices with the relevant requirements of the EU MDR.
This includes expertise in areas such as clinical evaluation, risk management, quality management systems, and regulatory affairs.
3. Independence and Impartiality
Notified bodies must operate independently and impartially, free from any undue influence that could affect the objectivity or integrity of their conformity assessment activities. They must establish and maintain procedures to manage conflicts of interest effectively.
4. Quality Management System
Notified bodies must have a quality management system (QMS) in place that meets the requirements of the EU MDR. This QMS should ensure the consistent and reliable performance of conformity assessment activities, including document control, personnel competence, and audit processes.
5. Assessment Procedures
Notified bodies must establish and maintain documented procedures for conducting conformity assessments of medical devices.
These procedures should outline the steps and criteria for evaluating devices’ conformity with applicable requirements, including clinical evaluation, technical documentation review, and quality management system assessment.
6. Competent Personnel
Notified bodies must employ personnel with the qualifications, expertise, and experience to perform their duties effectively. This includes experts in various relevant fields, such as clinical evaluation, regulatory affairs, biomedical engineering, and quality assurance.
7. Transparency and Communication
Notified bodies must ensure transparency in their operations and communicate effectively with manufacturers, authorities, and other stakeholders. They must provide transparent information about their processes, fees, timelines, and any decisions made regarding conformity assessment.
8. Monitoring and Surveillance
Notified bodies are subject to ongoing monitoring and surveillance by competent authorities to ensure compliance with the EU MDR requirements.
This includes regular audits, assessments, and inspections to verify the competence and performance of notified bodies in conducting conformity assessments.
By fulfilling these requirements, notified bodies play a crucial role in ensuring the safety, quality, and effectiveness of medical devices placed on the market within the European Union under the EU MDR regulatory framework.