Unique Device Identification (UDI) in light of new legal regulations

The topic of unique device identification has been previously discussed on our blog. Today, we want to introduce you to updates concerning changes in current regulations.

UDI regulations were developed and implemented by the US Food and Drug Administration (FDA), the European Commission, and global regulatory bodies. Their primary goal is to enhance patient safety and elevate the quality of healthcare. Under initial assumptions, the obligation to place codes on medical labels and packaging was scheduled to apply no earlier than May 26, 2021 (Class III). Differences in implementation timelines depended on the respective device classes.

On January 6, 2023, the European Commission adopted a proposal to amend the MDR (Medical Devices Regulation) regarding the extension of transition periods for medical devices. This is extremely vital information for medical device manufacturers who had spent months worrying they might fail to complete MDR-compliant procedures and certifications in time.

The extension of transition periods applies to Class III and implantable Class IIb devices until December 31, 2027, and to Class IIb, Class IIa, and sterile or measuring-function Class I devices until December 31, 2028. All Class I devices under the MDD (Medical Device Directive) that, according to the MDR, should be reclassified into a higher class may be placed on the market under certain conditions until December 31, 2028. The extended deadlines apply exclusively to manufacturers who submit a formal application for certification to a notified body no later than May 26, 2024. An important element of the changes is also the abandonment of the “sell-off” clause; thanks to this, devices legally placed on the market before May 26, 2021, will remain on the market longer than May 2025.

At Prespack, we provide services dedicated to the pharmaceutical and medical sectors. On a daily basis, we cooperate with both medicinal product manufacturers and medical device makers. We provide services in contract packaging, repacking into unit packaging, as well as their serialization and aggregation. We are committed to supporting our clients, which is why we gladly share knowledge regarding regulatory changes and updates.