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MDR Certification

29/01/2023 July 14th, 2023

Digitec Software Platform (DSP)- Tiresya is now MDR compliant!

What is MDR?

The new Regulation (EU) 2017/745 or MDR (Medical Devices Regulation) is the European regulation on medical devices which defines regulations and constraints that all manufacturers and distributors must comply with in order to place a Medical Device (DM) on the European market.

The MDR stems from the need to adapt the legislation on medical devices to the needs of the future, in such a way as to prepare an appropriate, solid, transparent and regulatory framework, harmonizing the functioning of the internal market of the European Union.

Entered into force on 25 May 2017 (with full implementation on 26 May 2021), the new regulation, in addition to integrating and replacing the previous Directives 90/385/EEC and 93/42/EEC, provides for more stringent requirements and measures, in line with the evolution of the medical device market globally.

We are proud to announce that we have obtained the MDR 2017/745 certification.

After intensive work by the entire team, we have received the new MDR 2017/745 certificate for DSP.

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