EAAR, together with MedTech Europe and other associations, contributed to a joint position paper on the MDR and IVDR simplification proposal, highlighting a more proportionate and effective approach to life‑cycle oversight.
As the voice of the Authorized Representative (AR) community, EAAR emphasizes that ARs play a central and indispensable role in ensuring regulatory compliance, particularly for non‑EU manufacturers. A simplified framework must therefore continue to recognize and reinforce the AR’s responsibilities across the entire product life cycle. EAAR supports the proposal’s shift toward a more targeted, risk‑based and proportionate approach to oversight—reducing unnecessary administrative burden while maintaining strong safeguards for patient safety
