Legal Implications for Manufacturers and Other Stakeholders Under MDR

EU Regulation No. 2017/745 on Medical Devices (the “MDR”) sets new requirements for each economic operator involved in the supply chain (i.e. manufacturer, authorised representative, importer and distributor) aimed at ensuring the proper functioning of the market. In order to enforce that every subject involved adheres to the new legislation, specific tasks and a duty of monitoring is imposed on each operator. This has a significant impact on the entire production and distribution chain and the business organisations of the relevant stakeholders by holding all those involved responsible for strict compliance with the rules. In this chapter, we will analyse the main new obligations placed on each economic operator, highlighting the key challenges that the Medical Device industry will have to face.