A Notified Body is an independent conformity assessment organisation designated by an EU member state to assess whether a manufacturer and its devices meet the requirements of the Medical Device Regulation or the In Vitro Diagnostic Regulation. For every device above the lowest risk class, a Notified Body must be involved before the CE marking can be applied.
The UK equivalent under the UKCA regime is an Approved Body, designated by the MHRA. The role is functionally similar, though the two systems are legally distinct and a designation under one does not confer status under the other.
A Notified Body is not a government regulator and cannot issue market authorisations in its own right, nor can it act as a consultant to the manufacturer it assesses. That independence requirement is strict: the same organisation cannot both write a manufacturer's technical file and certify it. Manufacturers therefore need separate regulatory consultancy support if they want that expertise.
The number of designated Notified Bodies fell sharply during the transition to MDR, while demand rose because more devices required their involvement. The result has been long queues, competitive selection and lead times that must be built into product plans. When choosing one, manufacturers look at the scope codes they are designated for, their experience with the relevant technology, realistic timelines and their approach to review questions, since a poor fit can add many months to market entry.
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