Austria: MDR Implementation at national level

Austria has implemented Regulation 2017/745 through the Medical Devices Act in force from 30 June 2021.

The Act provides clarifications in the following areas:

Competent Authorities

The competent national authority with regards to MDR 2017/745 is the Federal Office for Safety in Health Care, while the competent authority concerning market surveillance is the Federal Office for Health Safety.

Requirements for medical devices

Article 5 of the Act precludes the manufacturing, installment, putting . . .


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