From Directive to Regulation: The path to MDR 2017/745

The transition from the former Medical Devices Directive (93/42/EEC) to the Medical Device Regulation (EU) 2017/745 (MDR) represents a major shift in European legislation. Unlike a directive, which must first be transposed into national law by each Member State, a regulation is directly applicable across all Member States. This enhances consistency within the European internal market, while still allowing for additional national requirements where explicitly permitted by the MDR.

The MDR was introduced in response to widespread concerns that the previous legislation lacked sufficient clarity in areas such as clinical evidence, transparency, and market surveillance. As early as 2000, an EU-wide survey indicated that while the existing framework was functional, improvements were needed in the areas of clinical investigations, Annex II procedures, and technical documentation.

A key milestone in this evolution was the adoption of Directive 2007/47/EC, which came into force in 2010. This was followed by the publication of the first draft of the MDR in 2012. Over the subsequent years, the proposal underwent an extensive review process within the European institutions, with hundreds of amendments tabled and debated. Although the legislative process was complex, it ultimately resulted in a more robust and future-proof regulation.

The final MDR text was published in May 2017, with a transitional period lasting until May 2021. Since then, the MDR has been fully applicable, aiming to improve patient safety, strengthen product traceability, and enhance oversight of manufacturers and Notified Bodies.