When this applies
When a device turns out to have a second kind of body contact that the existing plan did not cover — a surface-contacting device that also has a fluid path, say, or an accessory whose contact duration differs from the parent device. ISO 10993-1:2025 assigns endpoints by contact type and duration, so a new category brings its own endpoint set rather than inheriting the first one.
When to run it
As soon as the additional contact is identified, and before the testing programme is locked. Discovering a second contact category after the studies are commissioned is the expensive version of this conversation.
What you receive
An assessment of the added contact category and the endpoint set it requires, written to extend your existing plan or report. It is a supplement, not a replacement document.
What it does not do
It does not stand alone — there must be an existing biological evaluation plan or report for it to extend. It also does not perform the endpoints it identifies; it establishes what is now in scope.
Method
Assessment per ISO 10993-1:2025. The additional contact type and duration are categorised and the resulting endpoint set is determined and justified against the existing evaluation.
Who performs it
This is performed by Groenakker, not subcontracted. The document is issued in Groenakker’s template — or in yours on request at no extra cost — under Groenakker’s ISO 13485:2016 certified quality system.
Usually ordered alongside
The Biological Evaluation Plan or Report being extended, and a change impact assessment where the new contact category arose from a device change.
