ed and assessed according to the principal intended purpose of the combination, and it is the entire kit that would receive the CE marking. However, sometimes kits include products that clearly are not included in the scope of the IVD Directive, like medical devices or general laboratory products. For IVD kits that include medical devices, the medical devices themselves must be CE-marked according to the Medical Devices Directive, and then the combination would be CE-marked according to the IVD Directive. General laboratory products can also be included in kits with IVDs, but wouldn’t be CE-marked in their own right.
The proposed EU regulations on IVDs aim to erase some of these borderlines by specifically including, or excluding, some borderline IVDs. In the meantime, however, relying on LNE/G-MED’s regulatory guidance and the medical purpose of the product could help an IVD manufacturer to define what type of product they have.
For more information on the services that LNE/G-MED offers to IVD manufacturers, contact us.
1 Guidance on legislation: Borderlines between medical devices and medicinal products, MHRA. Guide to Cosmetic Biocide Borderline Products. Irish Medicines Board.
2 98/79/EC Art. 2(b).