VP Regulatory Compliance, Qserve Group US Inc.
Declarations of Interest for Clinical Evaluators – what will be sufficient to meet the requirements in MEDDEV 2.7.1 rev 4?
2 min reading time
In addition to the qualification requirements for clinical evaluators (prescribed in section 6.4 of MEDDEV 2.7.1 rev 4 which was published June 29, 2016), each of the evaluators must provide a detailed “Declaration of Interest” detailing all relevant financial interests (aside from the work as clinical evaluator). Full details are given in Appendix A11.
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?
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” evaluators from being “objective” if they have shares in the company, or received a bonus. However, it’s not clear to me on what basis they might make this distinction from an employee receiving a salary, and 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. Do any of you have experience with this? How did your Notified Bodies interpret the declarations of interest in these cases?
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Ronald Boumans Nowadays I recommend clients who want to use employees as reviewer to add a paragraph to the employment contract (or have a separate agreement drawn up) that they will have the task of performing objective scientific reviews and that they will not suffer any disadvantage in their work as a result of their review results. However, so far this arrangement has not been tested in a TF review by a notified body.
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