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?

A presentation by Massimo Marcon, Chairman of the board of IACER Srl.

View of the Speaker

Question 1: What drives you?
As a member of the board of “Confimi Industria Sanità” I represent 1.200 SMEs of the Italian Medical System. in Confimi Industria Sanità we feel the responsibiliy to protect manufacturers and distributors of Medical Devices in order to guarantee their availability to the sanitary systems and also to maintain employment.

Question 2: Why should the delegate attend your session?
Because the European Medical Devices Industry plays a strategic roule for the healthyness of our continent, therefore we have to protect it!
This is a direct responsibility of everyone which is involved in the medical business.

Question 3: What emerging technologies / trends do you see as having the greatest potential in the short and long run?
We believe that Telemedicine and Telerehabilitation would play a very significant role in future

Question 4: What kind of impact do you expect them to have?
Better quality of life of patients, by improving their health in the warmness of their homes

Question 5: What are the barriers that might stand in the way?
To achieve this goal of Telemedicine we need to put together a consistent amount of software systems and Applications, as well as to coordinate thousands of medical operators in respect of the GDPR prescriptions. This is our big challenge,

About Massimo Marcon
After the degree in Economics in 1995 I founded my first company “Prima Srl” at the age of 28. I’ve been an entrepreneur ever since, and I’m now directing IACER Srl, a registered manufacturer in the industry of Medical Devices (2a and 2b classes)

The healthcare system, in the field of pain therapy and rehabilitation, is profoundly changing.
The global guidelines are directing institutions towards the decentralization of basic health services, increasingly promoting home therapy.
Improving the quality of life of patients is possible by reducing pain and increasing their mobility. This is why we have specialized in the design and manufacturing of electro-medical devices for pain therapy and rehabilitation.

Massimo Marcon is speaker at the 2022 edition of the Health Tech Event,Innovation meets regulation.

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