MDR: a Notified Body perspective and beyond.

Notified Bodies are a key player in the implementation of MDR. Acting as the main agents of Europe and the local Competent Authorities, we are at the forefront of the changes, in our case the new MDR and Brexit, that need to allow the industry to keep and bring Medical Devices to the European market.
This is a daunting task which needs to be finalized by May 2024 with the majority of the work still laying ahead of us.

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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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