I received an interesting question from a client the other week, regarding whether she could continue to be the clinical evaluator for her company’s clinical evaluation reports (CERs). The person in question has a PhD in biology (2006), 8 years’ post-doc work and experience in clinical research. Her concern was with regard to the “Declarations of Interest”, since she is an employee of said company.
Rev 4 of this MEDDEV, published June 29, 2016, is much more prescriptive in many ways, including with regard to the qualifications required for the evaluators of the clinical data.
In section 6.4 the document now requires the clinical evaluators to have knowledge of all of the following:
- Clinical investigation design & biostatistics
- Information management/retrieval (e.g. librarianship qualification, experience with Embase and Medline, scientific research background)
- Regulatory requirements
- Medical writing expertise (e.g. scientific research experience)
As well as the following knowledge for the device under evaluation
- Its technology and application
- Diagnosis & management of the condition being diagnosed/managed by the device, including knowledge of medical alternatives and treatment standards and technology (e.g. specialist clinical expertise in relevant medical specialty)
And have the following training/experience:
- A degree (in a relevant field) and 5 years documented professional experience OR
- 10 years documented professional experience (if a degree is not a prerequisite for a given task).
While most of that was already in the rev 3, it’s still a broad and deep base of knowledge for any single individual to have (e.g. detailed knowledge of regulatory requirements AND specific medical knowledge) and so in most circumstances a team of evaluators will be used by manufacturers. In my specific client’s case, I believe she was one of the exceptions who fulfilled all the requirements by herself.
In addition to all this, of course, each of the evaluators must provide a detailed Declaration of Interest detailing all relevant financial interests (aside from the work as clinical evaluator), such as holding shares in the company which could be affected by the outcome of the clinical evaluation, any grants sponsored by the manufacturer, employment by the manufacturer and interests in patents, copyrights and royalties, for example. Full details are given in Appendix A11. This was the specific area of concern, in this case.
While it is clear that Notified Bodies will ensure that suitably qualified experts have been included in the evaluation of clinical data to meet all the qualification requirements from section 6.4, it is less clear what they will do when interpreting the Declarations of Interest.
For example, will they “disqualify” evaluators who are employees of the manufacturer (the original question)? I don’t believe so, although that is a personal opinion, and I don’t know for sure what the position of the Notified Bodies will be.
Will they “disqualify” evaluators who have a stake (i.e. shares) in the company? At what level?
Or perhaps those that have been given grants by the manufacturer?
If so, presumably the manufacturer would need to do the clinical evaluation all over again, or at least, get it re-reviewed by an evaluator who does not fall foul of these requirements.
Anecdotally, I’ve heard that it is more likely the Notified Bodies will “disqualify” such evaluators from being “objective” if they have shares in the company, or received a bonus. However, this is far from hard fact at this point.
I’d love to hear what your experiences have been.
I know that some Notified Bodies have already been reviewing to the requirements of rev 4, even before it was formally published in June. What experiences have those of you who have gone through this scrutiny already had? How did your Notified Bodies interpret the declarations of interest of the evaluators?
Perhaps there will be an opportunity for us to share these experiences at one of the upcoming events which I am attending in the USA:
- ORCA event, Seattle, WA, Aug 11 on Access to the Chinese Market for medical devices (website)
- RAPS SF event, Fremont, CA, Aug 17, MEDDEV 2.7.1 rev 4 presentation & workshop (website)
- RAPS Convergence, San Jose, Sept 17-20 (booth and talk on PMCF) (website)
- ORCA event, Seattle, WA, Oct 5, MEDDEV 2.7.1 rev 4 presentation (website)
Written by: Keith Morel, VP Regulatory Compliance at Qserve Group US.
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