by Craig Rotzoll, Regulatory Project Director
The revised European guidance regarding Clinical Evaluations (MEDDEV 2.7/1 rev 4) was released in June 2016. It revealed a course change to a more prescriptive and demanding set of expectations. Much of the information contained in the previous version appears to have been repackaged to walk the CER authors (“evaluators”) through the process in a more systematic fashion.
As a result, each stage of the process (termed stages 0: Scoping, 1: Identify, 2: Appraise, 3: Analyze, 4: CER) is now presented within a focused section of the updated document. Detailed instructional criteria and expectations for each of the stages are also provided as appendices and further guide the process and anticipate the output.
- All should note that this guidance update has a significant impact on the methodology and final draft of all new or updated CERs. As such, it is important that each manufacturer carefully reads and understands the effect of this new revision. Though not exhaustive, the following bullets highlight areas with additional emphasis which impact the content and methods employed for updating CERs:
- State of the art: Though lightly included in the previous version, the updated version now suggests the inclusion of a separate literature search designed to exclusively retrieve detailed information on current knowledge/state of the art. Such information includes: applicable standards; description, natural course and consequences of the medical condition; description of the available options including risks and benefits; treatment hazards due to the technology or materials, etc. The search strategy and retrieved information are suggested to appear as a separate section within the CER.
- Essential Requirements: There is now a heightened awareness and emphasis of the Essential Requirements in regards to the planning (i.e., scoping), analysis, and conclusion of the clinical evaluation. While a reference to the Essential Requirements was omitted in the Analysis of the Clinical Data section of the previous version, the new version dedicates a multiple page appendix to this topic.
- Equivalent Devices: Appendix 12 (Activities of Notified Bodies) states the notified body “should challenge the ability of the manufacturer to access information that are relevant to the demonstration of equivalence” and concedes that a determination of equivalence “might be difficult or impossible in case of limited access to the technical documentation of the devices.” Much of the information now needed to prove equivalence may require proprietary access to the proposed equivalent device’s specifications and performance test data, or may require new sponsored testing. Though the base areas of equivalency remain the same (i.e., the clinical, technological, and biological realms) the bar for equivalency has been raised considerably to a point in which previously included “equivalent devices” might now only be eligible for the state of the art discussion.
- Evaluators: The manufacturer is to define the requirements of the evaluator (individual or team) and justify the choice of the evaluator(s).
- CER Updates: Updates are to occur “at least annually” for significant risk devices and for those devices that are not yet “well established” OR every two to five years (coordinated with the notified body) for non-significant risk devices that are “well established.” Please note the key term here is “well established,” which unfortunately was not defined in the updated guidance.
The full European Commission guidance can be found at http://ec.europa.eu/DocsRoom/documents/17522/attachments/1/translations/
Contact Samantha Thrun at firstname.lastname@example.org or 952-224-2260 to be put in touch with an RCRI advisor who can make sure all your CERs are in compliance.