The Regulation (EU) 2017/745 (also known as MDR) transition time of three years is about to end – by May 26th 2020 manufacturers of currently approved medical devices need to meet the requirements of the regulation. However, a lot of questions on the compliance procedures have emerged during this transition period. In order to support…

As of April 2017, the EU adopted the new Medical Device Regulation (MDR 2017/745), replacing the two existing directives, the Medical Devices Directive and the Active Implantable Medical Devices Directive: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002…

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