MedTech Europe calls for EU rule changes on electronic instructions for near-patient tests
MedTech Europe has published a booklet calling on EU policymakers to modernise rules to permit electronic instructions for use (eIFUs) for near-patient testing devices. Under current EU In Vitro Diagnostic Medical Devices Regulation 2017/746/EU, paper instructions remain mandatory for near-patient testing devices, while the European Commission recently permitted eIFUs for other medical devices under the Medical Devices Regulation 2017/745/EU through Commission Implementing Regulation (EU) 2025/1234. The trade association argues that nearly 90% of healthcare professionals prefer electronic over paper instructions, citing benefits including improved accessibility, reduced environmental impact, and up-to-date information availability. The booklet highlights that Europe represents approximately 30% of global point-of-care testing by volume, with Germany alone having over 10,000 point-of-care testing analysers installed in healthcare facilities by end-2023. MedTech Europe proposes that paper copies should remain available free of charge upon request, but argues automatic provision is unnecessary when electronic versions are preferred by healthcare professionals.