Abstract

The regulatory framework around medical devices in the European Union has always focused on upholding patient safety. However, over the years, certain scandals have come to light in which patient safety has been compromised considerably. As a consequence, the overwhelming opprobrium was the cause for a radical change. The new Medical Device Regulation (MDR) has now been introduced (but yet to be fully implemented) to primarily combat the issues that have arisen as a result of these scandals. The MDR has been subject to significant commentary, particularly the effect it will have on relevant stakeholders. The stakeholders in the context of the MDR are the manufacturers, distributors, authorised representatives and importers. There is a general consensus among various professionals that the new requirements are far more onerous than the obligations contained in the previous regulatory framework. Moreover, there has been a lengthy delay in the date of application for the MDR. In particular, the approval of the notified bodies is raising a great concern. This paper will provide a critical analysis of the new requirements that stakeholders must comply with and, in addition, will review the postponement of the MDR.