Guest blog: no enhanced patient safety resulting from rapporteur Roth-Behrendt's proposal

time and money

I am very pleased to publish a guest blog by Annet Muestege, director and co-founder of Applied Clinical Services BV., which dives into the clinical aspects of the DRB report proposal in significant detail. Since I am only a lawyer, I am very happy with the clinical picture with respect to this proposal from someone as knowledgeable as Annet. Annet is also a blogger like me, and I recommend her blog Medical Devices Clinical. It does a great job of providing the clinical perspective in medical devices regulation. Are you a writer and interested in writing a guest blog like Annet and James did? Just let send me an email with a proposal.

So, take it away Annet:


Time and money, similar to pharma, that is what I think the changes to the proposed European Medical Device Directive will require when reading the Roth-Behrendt report. Looking at it from clinical research perspective:

Randomized Controlled Trials

The report seems to be driving towards a more medicinal product oriented approval process including randomized clinical trials. The phrase

“Clinical investigations for medical devices, where made compulsory in accordance with this Regulation, shall include randomized clinical investigations in the appropriate target population and well-controlled investigations”

to me suggests that a randomized clinical trial always is required as part of your pre-market clinical evaluation for the higher classes of medical devices. An activity that may be unnecessary or even inappropriate in certain situations – for example when an alternative treatment does not exist – and will demand a substantial larger clinical investment as compared to a single arm clinical trial.


The term efficacy is added throughout the report and at some points even seems to replace the term performance. The statement that

“Performance should notably be understood broadly so as to encompass efficacy and benefit to the patient, which shall be checked in cases where clinical investigations apply”

tells me the report is moving from the requirement to show clinical safety and performance before marketing authorization to clinical safety and efficacy. Proof of efficacy will require more and different clinical data and thereby will require a significant larger clinical investment in money and time.

Ethics Committee

The proposed amendment suggests adding a complete section regarding authorization of clinical investigations by independent Ethics Committees guarding the rights, safety and well-being of subjects participating in a clinical investigation. Nothing surprising there when you are used to following ISO 14155 for your clinical trials, but the explicit mentioning here does not leave room for any clinical investigations being conducted without Ethic Committee approval.

Postmarket surveillance

The report promotes a more pro-active attitude towards postmarket surveillance: requiring instead of suggesting the installment of registers for class IIb and III medical devices to collect experience related to the use of these devices. Together with the suggested independent scientific review of the PMCF evaluation report for class III medical devices, this will again add to the clinical administrative burden. When well handled though, this aspect of the report can also have a positive impact on patient safety for the higher class devices, and creates opportunities for the medical device industry for publications on long term product safety and effectiveness to drive market adoption as previously blogged.


Besides pushing towards a PMA like structure as Vollebregt and EUCOMED already mentioned, it seems the Roth-Behrendt report is moving towards a more medicinal product-like approval process. When implemented, the above elements will significantly add to the clinical evidence burden before market access and require a substantial investment in time and money, thereby delaying time-to-market. Also, I cannot help but wondering how these measures would contribute to enhance patient safety, which is the ultimate goal of the proposed changes to the European regulatory system. The only positive element in that respect I find is the enhanced attention to postmarket surveillance. To be continued…

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