New European guidance on borderline products.
The European Commission has recently updated an important guidance document on determining whether or not a medical product is subject to medical device or medicinal product regulations. In addition, a new manual that provides practical examples has also been issued. This article discusses these documents.
Donawa
Maria E
ME
Donawa Lifescience Counsulting, Piazza Albania 10, I-00156 Rome, Italy. medonawa@donawa.com
D018795:Device Approval / Q000331:legislation & jurisprudence; D004864:Equipment and Supplies / Q000145:classification / Q000592:standards; D005062:European Union / Q000458:organization & administration; D033161:Government Regulation; D019983:Guideline Adherence / Q000331:legislation & jurisprudence; D017408:Guidelines as Topic