Insights

Clarity on a market built to confuse

Short, practical reads on the regulation that decides whether your device reaches the market and stays on it. No jargon for its own sake.

EUDAMED goes mandatory in 2026

The EU device database stops being optional from November 2026. A plain English look at who has to register, when, and what to do now.

After Brexit you need a UK Responsible Person and an EU Authorised Representative. Running them as two contracts costs you more than money.

Most IVD manufacturers think they are further along than they are. A Gap Assessment tells you the truth before a Notified Body does.

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A plain English map of every MDR, IVDR and EUDAMED date, and what to do before each one. Sent straight to your inbox.

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