Martin Belov

Dottrina

10 Marzo 2021

EU Regulations 2017/745 and 2017/746 concerning, respectively, medical devices and in vitro diagnostic medical devices, introduce an important novelty, such as the obligation to appoint a person within the company who is responsible for compliance with the legislation (so-called responsible person or PR). The legislation provides for this obligation for the manufacturer, including micro / small enterprises, and also for the agent. More precisely, then, while the manufacturer will have the obligation to identify the PR within his own organization, for the agent and micro / small enterprises it will be sufficient to demonstrate that they can have it permanently and continuously.

Dottrina

25 Agosto 2020

The paper aims to outline the main features of three important factors for human rights’ protection in the sphere of manufacture, testing and placing on the market of medical devices. These are the regulatory compliance officers, the ethical committees and the informed consent. All of them are provided by Regulation (EU) 2017/475 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR).