Qualifying the evaluation team and signing the report
The guidance on clinical evaluation of medical devices asks that the evaluation be conducted by suitably qualified people and names medical writing among the knowledge they need. Those criteria can be met by a team rather than by one person, and the medical writer on that team can appear in the report itself, by name, CV, declaration of interest and signature.
The evaluators' qualifications
MEDDEV 2.7/1 revision 4 indicates that the clinical evaluation should be conducted by a suitably qualified individual or a team. As a general principle, the evaluators should possess knowledge of research methodology, including clinical investigation design and biostatistics; of information management, for example a scientific background or a librarianship qualification and experience with databases such as Embase and Medline; of regulatory requirements; and of medical writing, for example post-graduate experience in a relevant science or in medicine and training and experience in medical writing, systematic review and clinical data appraisal. The guidance also requires specific knowledge of the device technology, of the diagnosis and management of the conditions the device is intended to manage, and of the medical alternatives to the device under review.
In one regulatory writer's view, it is acceptable for the evaluators to satisfy these criteria collectively rather than each meeting all of them, because it is very difficult to find one person with the whole skill set, so the work falls to a whole team. One member does the medical writing, another the informatics, and so on. In her experience, the end of the report carries a table recording who meets which knowledge or skill requirement.
MEDDEV 2.7/1 revision 4 is the only guidance this writer knows of that names medical writing as a knowledge area or skill required of the author or evaluator of a clinical evaluation report. On her reading, the guidance seems to set a minimum of five years' experience, in medical writing rather than necessarily in devices. A session at AMWA's 2018 conference took the guidance to require writers and reviewers of the report to hold a PhD or master's degree plus five to ten years of medical writing experience.
The qualification rule carried over to the MDR: as the notified body BSI noted in 2022, MDCG 2020-6 indicates that MEDDEV 2.7/1 revision 4 is still applicable, for devices reviewed under the MDR, on the question of who should perform the clinical evaluation. For gaining the training and experience the guidance requires, BSI pointed to its own webinars and roadshow presentations, and to its presentations at bodies such as RAPS, TOPRA, the Association of British HealthTech Industries and the British In Vitro Diagnostic Association, which manufacturers, consultancies and other service providers widely attend. It added that its Clinical Masterclass webinar series provides much additional information.
The writer's name and signature on the report
The medical writer's place on the evaluation team shows in the report itself: in the same writer's account, medical writers are required to attach their CV to the clinical evaluation report as an appendix. They are also required to write a declaration of interest and to sign off the report.
Definitions of ghostwriting vary, but in her view writing a clinical evaluation without acknowledging the writer is probably ghostwriting. In her experience, her name usually has to appear on the report, so she is not a ghost but a part of the evaluation team, though she did not know the practice in other industries.