The European Council has at last adopted their common approach on the proposed Medical Devices Regulation a full year after their colleagues in the European Parliament and adopted their text on 30 September 2015.
The European Council and the European Parliament
are co-legislators of the Medical Devices Text. Based on a proposed suggestion from the European Commission, they
both develop their own opinions on the text separately, develop their own
altered versions, and then engage in negotiations or “trialogues” in order to
come to an agreement on what the final legislation should be.
The text now includes a requirement that notified bodies who assess applications for a market authorisation for a medical devices, must also take into account what modelling and simulation has been performed by the applicant.
This represents a huge change for the medical devices industry and could very well mean the difference between products being on the market and not.
While modelling and simulation is used to some extent in informing decisions on how best to use a medical devices (eg: stent implanting) how modelling and simulation can be used in the assessment of efficacy and safety of medical devices is an entirely new and murky area.
Should this provision form part of the final text, this could well be the beginning of setting new guidelines on modelling and simulation in product development.
The first trialogues are due to start on 13 October 2015.
The full text of the Council document can be found here.