Clinical Evaluation

Clinical Evaluation:

New requirements for the clinical evaluation of medical devices. How to interpret the Meddev 2.7.1 Rev 4 and Annex XIV of the EU 2017/745.

 

Meddev 2.7.1 Rev 4 which includes more detailed clarifications compared to the previous version will provide valuable guidance to the manufacturers during their transition from 93/42/EEC and 90/385/EEC to the new MDR 2017/745.

Within the new EU MDR, requirements for clinical evaluation are given within Article 61 (Chapter VI) and Annex XIV Part A. Within this new era, the main challenge for the manufacturers will be to demonstrate the scientific validity of their data and conclusions. Annex XIV has a clear requirement stating that “The clinical evaluation shall be thorough and objective, and take into account both favourable and unfavourable data” . This and other requirements within the MDR and Meddev 2.7.1 Rev 4 will increase the importance of the clinical data to be reviewed.

The new term “demonstration of equivalence” is aligned with the new Meddev and discusses technical, biological and clinical aspects of the devices under consideration. These characteristics shall be similar to the extent that there would be no clinically significant difference in the safety and clinical performance of the devices. Substantial equivalence shall be based on proper scientific justification. It shall be clearly demonstrated that manufacturers have sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence.

Compared to Rev 3, Meddev 2.7.1 Rev 4 tries to clarify the existing requirements, rather than to introduce new requirements based on Article 61 of Chapter VI of the MDR.

The main changes and clarifications can be summarized as below;

  • Scoping and defining the specific objectives of the CER: Revision 4 has a very detailed section which explains how to define the scope of the clinical evaluation. Section 7 and Appendix 5 defines the requirements for the objectives of the CER to be linked to specific safety, performance data and risk-benefit analyses results.
  • Qualifications of the personnel performing the clinical evaluation: Clause 6.4 of the Rev 4 defines requirements for the expertise and experience. If the requirements are not met, deviations from these requirements should be documented and duly justified.
  • Frequency of updates to the Clinical Evaluation Report (CER): Meddev 2.7.2 Rev 4 requires the CER to be updated at least annually for high risk devices, and every 2 to 5 years for lower risk devices. The manufacturer shall give a proper justification for the frequency of the update. Of course for all devices the CER shall be reviewed and updated regardless of the defined frequency, whenever new information from the Post Market Surveillance (PMS) affects the conclusion.
  • Establishing the state of the art: The term “state of the art” is used in several sections of the Meddev 2.7.1 Rev: 4. The paragraph 8.2 defines in detail how to establish the state of the art.
  • Equivalence: In line with the new EU MDR requirements, the three criteria (clinical, technological, biological) for equivalence are clearly defined within the Meddev 2.7.1 Rev: 4. As a general rule, Rev 4 requires that design differences and their impacts on clinical safety and performance shall be described in detail. As required by the new MDR, the equivalence can be claimed only if all three criteria are met.
  • Access to the clinical data of the equivalent devices: Like the new MDR, Revision 4 requires that the manufacturers shall access to the clinical data of the equivalent device(s), when equivalence is claimed. Article 61 of the MDR requires especially for implants and high risk devices a contract between two parties , which allows explicitly access to the clinical data
  • Scientific validity of data: The new MDR and Meddev Rev 4 place much more emphasis on demonstrating the scientific validity of data, including statistical considerations. Literature search method, data appraisal and weighting and analysis of clinical data and demonstration of conformity have been explained in detail in the guidance document.
  • Need for clinical investigation: Appendix 2 of the Meddev describes the key points, how manufacturers should determine if they have sufficient clinical evidence and allowed not to perform a clinical investigation. Article 61 of the MDR places high standards especially for the implants and high risk devices. (Class III)
  • Risk-benefit analysis: Appendix 7 of the Meddev provides detailed guidance on the analysis of data to demonstrate device safety and performance. The evaluation and quantification of clinical benefits and risks, and an evaluation of the overall risk-benefit analyses are discussed within this appendix.
  • Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF): Throughout Revision 4 of the Meddev 2.7.1 and the new MDR, the links between clinical evaluation, PMS and PMCF are mentioned in several requirements and Appendices. As a general rule PMCF shall be planned and appropriately justified in light of the available clinical data. The Annex XIV of the MDR, which is called “CLINICAL EVALUATION AND POST-MARKET CLINICAL FOLLOW-UP” requires a clear plan for the process. The sample CER format will help manufacturers to comply with the Annex XIV requirements.

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