Impact of MDR on European SMEs system

The new regulation concerning Medical Devices (2017/745) and Diagnostics (2017/746) could have a dramatic impact on SMEs system. Right now, only a small amount of manufacturers are in compliance to the certification processes of the new Regulation. The risk in here is a shortage of Medical and Diagnostics Devices, that can have an effect on European Sanitary Systems, and on the health needs of the patients. How should we handle this challenge? This is the real question about our future. What about MDR and Telemedicine?

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Medical Device Development in the EU: Be prepared for the Queue!

An introduction in Medical Device Development in Europe, starting with the explanation of roles & regulations and do’s and dont’s in order to get your device on the market.
Followed by an overview of the current situation in the field regarding certification of medical devices and the queues at Notified Bodies.
Closing with some tips to be prepared!

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