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Announcement on the Significant Changes in the MDR Process

Announcement on the Significant Changes in the MDR Process

To the attention of all firms holding a certificate in the scope of the Medical Device Directive 

As of May 26, 2021, Approved Institutions appointed under 93/42/EEC Directive will not be able to have another first certification but it has been announced on NANDO that they shall be responsible under Article 120 of MDR 2017/745/EU for the monitoring activities of valid certificates issued under 93/42/EEC Directive.

UDEM Systems & Product Certification Services

We crown our achievements with originality with our sector experience and expert personnel, we continue to be the choice of professionals.

Without compromising our principles of impartiality, independence and confidentiality, we aim to be a leader not only in Turkey, but also in the global market, we are expanding our international network every day.

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