The deadline for ensuring compliance with the European Union’s Medical Device Regulations (EU MDR) is looming. These new, stricter regulations are aimed at improving the traceability features and safety management of medical devices for sale within the EU. The new regulations will have significant implications for medical device manufacturers and across production lines. This article discusses the different solutions available for manufacturers seeking compliance with EU MDR, highlights considerations and best practices, and explores what could be next for medical device regulations.

Recap: EU MDR Timeline for Compliance
The EU MDR replaces the EU’s current Medical Device Directive (93/42/EEC) and the Directive on Active Implantable Medical Devices (90/385/EEC). As part of the new regulations, manufacturers of medical devices for sale within the EU must adhere to strict guidelines to ensure their products are safe to use.

The regulations cover all medical devices sold in the EU – including everything from scalpels and needles, pacemakers, and prosthetic limbs to adhesive bandages, gauze dressings, and medical devices with a cosmetic purpose such as coloured contact lenses.

The regulations were originally due to come into force in 2020 but have been faced with a series of administrative delays. In 2023, the European Commission made the most recent extension to the EU MDR transition period, with the publication of Regulation (EU) 2023/607, to address the risk of medical device shortages in the EU market. In the current timeline, manufacturers of medical devices have until 31st December 2027 or 31st December 2028, depending on the risk class of the device, to ensure compliance with the new regulations.