The Dutch Health Inspection (IGZ) organized an invitational conference on clinical research with medical devices end of last year. Representatives of the different stakeholders, such as manufacturers, competent authorities, Ethics Committee’s, and health care providers were present during this conference and discussed the current system on this type of clinical studies. The summary and presentations that have been published on the IGZ’s website (see above link) are interesting to read, especially on the following items:
EU guidance and regulations
In his presentation regarding the regulatory environment on medical device clinical research, the Health Ministry representative, Van der Kroef, once more underlined that with version 4 of the MEDDEV 2.7/1 and the upcoming MDR (final text MDR just came out!), more clinical studies and more clinical expertise will be needed (also refer to an earlier post). The Health Ministry therefore calls for better alignment and cooperation between the different stakeholders.
Off-label use
Roles and responsibilities were discussed, and the IGZ emphasized that although by law the manufacturer/ sponsor has the ultimate responsibility, also other parties such as the investigators have theirs (be aware that the latter is also amended in the new version of ICH E6). Specifically off-label use was addressed in this context: Research physicians shall NOT apply a non-CE marked device which is not delivered according to the law, but manufacturers are hesitant to allow for studies outside of intended use. Following the FMS guidance could be a solution to guarantee a safe application of medical devices applied outside of their indication when devices are developed within a health care unit.
Patient Information Letter
Concern was expressed with respect to the patient information letter that informs the candidate study participant on the ins and outs of a clinical study. Requirements seem to differ for different rules and regulations, and are complicating its development. Web-based tools are considered helpful for the structure and completeness of the content, but, again, the manufacturer has the ultimate responsibility to ensure that the patient information is brief and clearly written (refer to my previous post on tips & tricks).
Observational Postmarket Studies
Thoughts were expressed that the new regulation will also impact the way clinical studies are submitted and reviewed, and options for a “WMO-light” have been discussed: review by an acknowledged Ethics Committee of studies that do not fall under the scope of the Medical Research Involving Human Subjects Act (WMO). The latter would include any Postmarket observational studies such as registries, so I think this is an important development to keep track of.
Conclusion
The Dutch Health Inspection together with the Health Ministry and CCMO will explore what elements of the discussed topics can be addressed, and are aiming for follow-up in the first half of 2017. I will follow the developments with interest and keep you posted. Stay tuned.
Do not hesitate contacting me to discuss the above or when looking for support for your medical device clinical studies. You can find my details in the upper right corner, click here to send me an e-mail.
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