On the 23rd of April Regulation (EU) 2020/561 of the European Parliament and of the Council amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions was published.

The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe. Compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace. The MDR includes new requirements on medical device traceability, e.g. Unique Device Identification (UDI). The UDI system is detailed in Part C of Annex VI of the EU MDR. Unique Device Identification allows for the unambiguous identification of a specific device on the market. UDI on device level is comprised of the so-called UDI-DI (Device Identifier) and the UDI-PI (Production Identifier). GS1 standards can help companies meet new legal requirements.

Such a decision was made by the EC and the EP in order to prioritise the fight against the coronavirus pandemic. However, the new date of application of the MDR is a chance for those companies that have never used any standards. These extra 12 months can help those entities understand the idea of standards and implement them in a way enabling both meeting the legal requirements but also streamlining logistics processes.