EU New Medical Device Regulation now in force! In silico mentioned for the first time

After a one-year postponement following the COVID-19 pandemic, the European Commission’s Medical Devices Regulation (MDR) entered into application on 26 May. The implementation calls attention to the need for enhanced availability of vitally important medical devices across the EU. Accordingly, the MDR pursues the development of a more adequate regulatory framework by improving the safety and quality of medical devices. It also seeks to provide increased transparency for patients and less administrative burden for companies.

When it comes to potential implications for in silico medicine, it should be noted that the dossier specifically provides the possibility of submitting computer modelling and simulation (CM&S) data to notified bodies. As such, the implementation of the MDR could give rise to a significant boost for in silico medicine applications. However, to date no legislation was established yet on the verification and validation of these models, the assessment of simulation results, nor on standard requirements of medical device companies when submitting CM&S data to support a market authorization or when seeking reimbursement.

Keeping that in mind, it appears all the more important that European regulators commit efforts to harmonising emerging regulations for the qualification of in silico methods in the context of regulatory purposes. Contrarily, any substantial difference between legislative dossiers would further delay the adoption of these methods. That is to say, companies investing in significant staff training on the use of in silico methods under one regulatory system would have to retrain if another regulatory system has very different requirements. The same principle applies to regulatory agencies: by co-developing the credibility framework for in silico methods, regulators can more rapidly face the challenge that these innovations involve.

Such a harmonisation process will however inevitably face some structural barriers. In the EU, the European Medicine Agency (EMA) jurisdiction is limited to medicinal products. Medical device regulation is instead under the responsibility of 33 National Competent Authorities, all acting under the MDR. Many of these authorities have limited technical infrastructures, potentially limiting their ability to actively contribute to the harmonisation process and ensure its robust adoption and implementation.

These reasons more than ever underline the importance of Avicenna Alliance’s commitment to ensure a forward-looking, harmonised policy framework to facilitate the large-scale development and acceptance of in silico medicine. Now is the time to make regulators aware of the incremental benefit a common EU level credibility framework for in silico technologies would have. Specifically, such harmonisation would enable healthcare systems to reap the benefits of these amazing technologies not only as healthcare applications, but even as part of regulatory processes in the future.



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