Whitepaper: Upcoming Changes to EU Medical Device Regulations

The implementation of the European Union Medical Device Regulation (EU MDR) is bringing a vast change to the labelling of medical devices.

EU MDR at its core widens the international standards of basic Unique Device Identifiers (UDIs), which contain information about a device:

• Its name
• Its version
• Number of uses
• Critical warning

EU MDR expands the scope of UDIs for medical devices in the European Union, including dynamic information such as batch number and expiry dates.

As companies struggled to understand the new regulations in medical device labelling, the threat of both new and existing products failing to come to market or meet the requirements to remain on the market forced an extension of the EU MDR transitional period; the EU MDR will now come into effect in 2027 or 2028, depending on a device’s risk class, with high-risk devices subject to the shorter transitional period, and mid- and low-risk devices’ transitional period ending in 2028.

This extension to the transitional period will allow more companies to prepare for medical device labelling. This new dynamic information means that more companies will need print and apply machines for medical device labelling, with systems able to print dynamic information in real time and apply labels appropriately.

With up to 15% of medical device recalls due to labelling errors, the importance of getting labels right the first time has never been more important. Cobalt Engineers can help with the installation of print and apply systems designed specifically for high-speed production and packaging lines in the life sciences industries.

Our Software Partners at Loftware NiceLabel have put together a guide to help understand the new regulations.

For more information on Whitepaper: Upcoming Changes to EU Medical Device Regulations talk to Cobalt Systems Limited