Bernasconi: The best way for industry to respond to the Implant Files is going to be to continue to support the implementation of the new regulations – however demanding and expensive that is going to be. We are not asking for more time to comply, as people suggest. What we are concerned about, however, is that the system – processes, structures and documents – is ready in time so that we can comply on time and raise standards at the earliest opportunity. Achieving a speedy rise in standards is not going to work if the framework itself is not ready until May 26, 2020. That is the date when many devices will already need to be compliant or, otherwise, taken off the market. Companies will need months of preparation to pass the stringent tests needed to reach that stage. One of the most critical areas in terms of timeframe is the readiness of notified bodies so that they can process requests for certification against the MDR and recertification against the Medical Device Directives. Now the system is under so much strain that it is difficult for all companies to find notified body capacity within a short timeframe, and the lack of readiness of the structures could threaten the ability of the sector to be ready on time.

MedTech Europe Chief Lauds Aims Of 'Implant Files' But Slams Its Methods

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