Notified body
Sector Deep DivesA private organisation designated by an EU member state to assess whether a medical device conforms to the requirements for a CE mark.
Also written: notified bodies
Medical devices are not approved by a central agency in Europe. The manufacturer demonstrates conformity with the Medical Device Regulation and obtains a CE mark, and for anything above the lowest risk class that conformity is assessed by a notified body designated and monitored by a member state.
Higher risk classes require clinical evidence and ongoing post market surveillance, so this is a substantive review rather than a rubber stamp. What it is not is a single verdict on a known date, which is the structural difference from a drug approval.
That difference reshapes the risk. Notified body capacity has been a documented bottleneck under the newer regime, and products certified under the previous rules have needed recertification. The consequence for a medtech company is queueing and cost, and for small legacy lines the rational answer is sometimes to discontinue rather than recertify.
So a medtech timeline risk is generally a delay, while a biotech timeline risk is generally an outcome. That is a large part of why devices carry earnings a multiple can be applied to and clinical stage biotech does not.
Worked example
A device maker plans a launch on the assumption that certification takes a given number of months and the slot is available when needed.
If assessment capacity is constrained, the launch slips a year. Revenue moves right, the development spend does not, and the product is still going to work. Compare that with a failed Phase III, where the asset is worth close to nothing the following morning.