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:
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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