Notified bodies fully support the objective of strengthening the position of micro and small manufacturers within the European regulatory framework and ensuring continued patient access to safe and effective medical technologies.
Team NB will continue to support SMEs through good value training to help them understand QMS/TD expectations.
That said, it is a false premise to position Notified Bodies as the mechanism to “sponsor” SMEs into market. The proposal for mandatory or expected fee discounts by notified bodies for micro and small medical device manufacturers raises substantial concerns regarding fairness, feasibility, and system sustainability.
Team-NB is proposing effective solutions including improving regulatory capability at source, increasing predictability of requirements, and ensuring oversight activities are applied in a proportionate and risk-based manner. And also, formalising structured dialogue, allowing greater flexibility in post-certification surveillance and sampling, establishing regulatory capability development (clinical investigations, laboratory testing, …), reducing operational burden on smaller organisations, advancing harmonisation of guidance, templates, and submission frameworks to improve quality of submissions.
A sustainable and resilient regulatory system built on proportionality, predictability, and shared responsibility would allow more effective support innovation from micro and small manufacturers, while continuing to uphold the highest standards of patient safety and public health.
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