With just over 5 months to go until the go-live date of the EU-MDR, the machine on guidance for implementation continues to focus on getting the structures in place. But one of the latest additions will have a larger effect, as it indirectly has a significant effect on MDR submission timelines and on the clinical strategy utilized by many companies of high-risk devices such as long-term implants.
The document concerned is the Commission Implementing Decision for the designation of clinical experts on medical devices, that is live on October 1 2019. Where the underlying documentation that was circulating in Brussels was over a hundred pages, the ultimate text of the additional piece of law is short and focused. It confirms that the expert panels are to be designated in order to provide scientific, technical and clinical assistance to the Commission, the Medical Device Coordination Group (MDCG), Member States, notified bodies and manufacturers in relation to the implementation of Regulation (EU) 2017/745 and in order to provide views in accordance with Article 48(6) of Regulation MDR.
The expert panel will consist of clinical experts in 11 relevant fields, ten large clinical areas and one covering IVDR. A twelfth section is specifically dedicated to supporting notified body conformity assessment in the scientific opinion process (previously called scrutiny process). The system is set up with clear mandates, processes will be in place, including leadership systems and administrative support. And obviously the experts will be paid for their time and travel costs a needed. So far, so good, an independent clear reflection on key elements of selected products where the broader opinion could truly matter towards safe and effective medical care.
But the document gives rise to quite some tensions and uncertainties, such as the following:
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Who will be in the panels, and more importantly, given the absence of any interest in the medical device industry in a broad term, surgeons and other employees with a contract to a hospital (that typically competes with industry under the exemption rules) are to be excluded? Especially in the IVD field, this independence state of reviewers is discussed much.
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Will the costs of reviews and opinions be affordable to the device industry, or will it lead to a decrease in innovation? Will the delays in market approval affect choices and priorities made by the innovators, moving the market launches elsewhere and thus delaying access to critical devices for European patients?
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As the notified body prepares to review documentation and send it their reports to the scrutiny panel, will they be more critical and demanding in their request for fully owned dedicated focused clinical studies on the subject products?
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Will notified body assessment of subject device to be postponed until the expert panel is fully in place? Will it be ready on May 26 2020, so that MDR reviews on new products can start? Are there different opinions by competent authorities leading to local differentiation?
Looking at the annex detailing days available to experts, as well as pricing, the cost of the reviews and opinions might be deemed acceptable; it is the unknown delays and uncertainty on demands that are the crucial elements of the debate. Questions being raised at this stage by manufacturers are on strategic choices.
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Should we go back and revisit the transition plan MDD to MDR (IVDD to IVDR) with our notified body? And if some submissions are delayed due to this process not being ready yet, should we get further early renewals on specific products? Is there time, and additional costs for rapid notified body reviews are getting extreme with day rates for reviewers and auditors rising well beyond 15.000 euro.
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Should we continue to further strike away products from the portfolio, and focus on less and less devices crucial to the sales rather than keeping a portfolio that serves patient needs?
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Should we delay reviews of innovative products further, in order to gain market access elsewhere and in time when further real-world clinical data is collected consider making a late submission into Europe?
Hopefully, the processes, timelines and availability of the expert panels will soon be clarified, so manufacturers can make well-informed choices! And should you reader think you might qualify as clinical expert for the EU, then, by all means, sign up and come to rescue!
