The MDCG endorsed a new guidance on the UDI-related obligations when it comes to medical devices that administer/incorporate medicinal substances, human tissues and cells as provided in the Article 1(8), 1(9) and 1(10) of the MDR. These articles govern which or part of which regulation (medical devices, pharmaceuticals, tissue, cell legislation) applies to the medical device part of a particular product.
The MDCG differentiaties between 2 types of categories:
First group is composed of products where the device part of a product is fully regulated by the medical devices legislation (MDR); consequently full UDI obligations apply to the device part of a product.
Examples: Catheters coated with heparin or an antibiotic; Soft tissue fillers incorporating local anaesthetics;
Second group contains products governed by other than medical device regulation (MDR), with the exception of the device part that needs to respect (solely) general safety and performance requirements laid down in Annex I of the MDR. Thus, UDI related obligations do not apply! This is explained by the fact that UDI obligations are not listed in the Annex I of the MDR. However, the MDCG considers that this does not result in a prohibition to place UDI on the device part of a combination product.
Examples: Patches for transdermal drug delivery; Wound dressings impregnated with an antibiotic, where the primary intended purpose is to administer the antibiotic to the wound;
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