Global manufacturers placing medical devices or IVDs on the EU market are facing a pivotal moment. Our latest advisory sets out details on the most significant reforms to the EU framework since the MDR and IVDR took effect, with particular emphasis on what these mean for international companies. For companies headquartered outside the EU, who already face additional hurdles such as appointing an EU Authorised Representative, navigating EU‑specific labelling and language rules, and registering in EUDAMED, the Commission’s proposed changes represent both a long‑awaited easing of systemic pressures and a clear signal to reassess EU market‑entry strategies.
In recent years, international manufacturers have struggled with the absence of grandfathering pathways, notified‑body bottlenecks, and high compliance costs, sometimes forcing a difficult choice between delaying or abandoning EU launches. The proposed reforms respond directly to these pain points, setting out measures that collectively reduce barriers to entry and provide non‑EU companies with more predictable planning horizons.
The reforms also target areas that have disproportionately strained international manufacturers: revised classification rules for software, structured notified‑body engagement with harmonised timelines, and regulatory sandboxes enabling early evidence generation for AI‑driven and emerging technologies. Coupled with international reliance provisions, these changes aim to reduce duplicated assessments across jurisdictions, a particularly welcome development for companies managing multi‑regional regulatory portfolios.
In addition, from 28 May 2026, the activation of four EUDAMED modules triggers new transparency and registration obligations. These include mandatory device and operator registration, certificate uploads, and ongoing data‑verification processes; requirements that carry operational consequences for global teams coordinating EU submissions from abroad.
Overall, the EU is signalling a shift toward a more proportionate, innovation‑supportive, and internationally coherent regulatory system. For global companies, the message is clear: now is the time to recalibrate EU strategy, refresh notified‑body planning and tighten regulatory operations to capture the benefits of a more navigable, yet still demanding, framework.
For more details – read our advisory and get in touch!