Posts Tagged ‘borderline products’
Borderline Medical Devices – Guidance Document
MEDDEV 2. 1/3 concerning borderline products, drug-delivery products and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative has been updated to take account of the changes introduced by the 2007/47/EC amendments and is available to download here.
This guidance document is essential reading for manufacturers of medical devices intending to CE mark combination products that incorporate a medicinal substance or a human blood derivative.
Drug or Device? – MHRA issues updated guidance on borderline cases
Directive Bulletin 17 provides updated guidance on the regulatory criteria for considering drug/device borderline products. It also contains a very useful appendix that lists a number of products and clarify’s their classification depending on intended use or mode of action.
