Our consultants are experienced with borderline products. We can advise which legislation applies.
Products do not always clearly fall within medicines or medical device legislation and there are many borderline situations. Foods, cosmetics, biocides and personal protective equipment are only a few examples of products falling on the other side of the borderline. We can clarify the demarcation of a specified product and advise on the applicable legislation. Or we can provide advice on how to avoid one particular side of the borderline. In both cases, we can prepare and obtain the necessary regulatory approvals on your behalf. We can even recommend corrective action, should you stray inadvertently into the wrong side of the borderline.