ECOO has joined with EuromContact and 10 other organisations to call on the European Commission and EU Competent authorities to begin work this year on a targeted revision of the EU Electronic Instructions for Use (eIFU) Regulation with a view to expand its scope.
The 12 organisations have called on the Medical Device Coordination Group (MDCG) to consider as a priority in its 2024 work programme the revision of Commission Implementing Regulation (EU) 2021/2226, with a view to expand the scope for specific product categories. Regulatory change would enable the transition from paper instructions for use to instructions for use in digital format.
The full statement is available here.