21 September 2026, MedTechLabel held a webinar untangling the legal, regulatory and standards landscape of digital labelling for Medical Devices (MDs) and In Vitro Diagnostic Devices (IVDs).

Petra Wilson (i~HD) introduced the regulatory and legal landscape of MD and IVD labelling, highlighting that it does not end  with the Medical Devices Regulation. In fact, five pillars shape the labelling environment, ranging from Device labelling over Batteries to Interoperability.

Roderick Seery (CEN/BH) then outlined the applicable standards and their complex interplay when it comes to medical digital labelling. The applicability of standards are influenced by the product and intended user, covering areas like electronic Instructions for Use (eIFUs), software safety and lifecycle, cybersecurity and access and meaning.

MedTechLabel industry lead Roger Peterson (Arthrex) highlighted the challenges and opportunities for digital labelling from a manufacturer’s perspective. He highlighted that the potential impact of digital medical labelling reaches far beyond digitization of information provided by manufacturers: improved patient care, healthcare delivery and clinical outcomes.

This sentiment was also echoed by the webinar participants. In interaction and question and answer sessions, they  named  enhanced patient safety as the biggest benefit of medical digital labelling uncertainty about applicable laws and standards as a major barrier. They identified the Medical Devices / In Vitro Diagnostics Devices Regulation and eIFU as the regulations and standards they encounter most – and where they feel the biggest need for clarifications.

The webinar was moderated by Lene Lunde (from scientific coordinator University of Oslo) and attracted 49 interested stakeholders from across Europe and the USA.