A regulatory strategy isn’t a document you write once and file away. Your device may not have changed, but the regulatory environment around it won’t have stood still. EUDAMED obligations, evolving MDCG guidance, conformity assessment requirements, Notified Body considerations and changes elsewhere in the EU regulatory landscape can all influence the best route to market.
The risk?
You can have a strategy that is technically correct, but no longer commercially optimal.
Discovering this late on in the project can be expensive: additional evidence required, unnecessary work, delays in conformity assessment or decisions that are difficult to reverse.
A good regulatory strategy is therefore a living market access roadmap, connecting classification, QMS, clinical evidence, technical documentation, Notified Body strategy and commercialisation planning.
At Starodub we help medical device companies identify regulatory risks early and build a practical route to EU market access. Are you developing an EU regulatory strategy, or wondering whether your existing one still holds up?Contact Starodub at www.starodub.nl for a regulatory strategy call.
