4th Revision of MEDDEV 2.71 published by EU Commission
On 29th of June 2016, the 4th revision of the MEDDEV 2.7.1 – Clinical Evaluation has been published. Generally, the MEDDEV guidance documents are provided by the Commission to assist Notified Bodies and manufacturers in implementing directives related to medical devices. Even though these guidelines are not legally binding, evaluating Notified Bodies expect the guidance to be followed. There is no transition period for those documents, which means that from now on, clinical evaluations should be done according to the revised guidance. The requirements for the documentation, literature evaluation, and clinical evaluations have increased.
- The identification, analysis, and extraction of data necessary for the clinical evaluation report have to be much more detailed and of higher complexity, beginning with a log file for the search and ending with the final literature attached to the report.
- The reports have to be updated more frequently
- The qualifications of the evaluator are increased and defined
- The term “equivalence” is narrowed to an extent, in that equivalence means having a nearly identical device, which probably will require new, device-specific clinical trials
a&r comments: Together with the upcoming new medical device regulation (expected to come into force at the beginning of 2020), we assume that a number of medical devices will have to update their clinical evaluation accordingly. New clinical evaluation reports, even for simple devices, will entail increased costs and cost expenditures.