How to identify the legal manufacturer for medical devices

The term “Legal Manufacturer” is one that has been floated about a lot in the last few years. However, it is not actually defined anywhere in EU legislation.

Check Regulation 2017 / 745 also known as the Medical Device Regulation, or EU MDR, or 2017/746 also known as the In Vitro Diagnostic Regulation or EU IVDR and you won’t find the term there.

Check the blue guide which is a horizontal guidance document that clarifies concepts like placing on the market, principles of CE marking and other essential aspects, does not define the term either.

So what is the legal manufacturer?

Let’s talk about the finished device and samples.

Do you get product samples?

One thing I always love to do when I'm working on a device under evaluation is get samples of the product in it's final form intended for the patient.

When you do this you can see the labelling, symbology, interact with the device as a user and evaluate the robustness of the packaging.

It enables a true comparison to the technical documentation of the actual device, and understand where we may have gaps, as well as how if our claims are consistent with what we're actually sending out. Don't be afraid to ask for samples.

Using this logic, when we get a sample, it is fairly easy to identify the legal manufacturer when you ask the right question, which to me is:

Who’s CE mark is this being placed on the market under?

This can be coupled with who’s name is the little black manufacturer logo against, but typically it’s against the CE mark owner.