EC: New Entries in the MDCG Borderline Manual
The Medical Device Coordination Group (MDCG) has updated its manual on the classification of products that are on the borderlines between medtech and other regulatory categories (Version 4).
The following newly added cases illustrate current regulatory decisions on qualification and classification:
- Red blood cell additive solutions containing adenine
→ Medical Device, Class III
Adenine exerts metabolic/pharmacological effects on RBCs; therefore, the solution is classified as part of a Class III device. - Dual-action cream with menthol and capsaicin
→ Not a medical device
Principal mode of action is pharmacological (via receptor activity); classified as a medicinal product. - Lactose vaginal tablets
→ Not a medical device
Mode of action is metabolic, based on lactic acid bacteria metabolizing lactose into lactic acid. - Microabrasion dental stain removers (tooth whitening)
→ Not a medical device
Purely cosmetic purpose (aesthetic improvement), no proven medical benefit. - Medical examination table covers
→ Medical device
Intended to prevent disease transmission (infection prevention), thus meeting the definition of a medical device. - Mobile sterile air system
→ Not a medical device
Controls the environment (air purification/laminar flow), without direct action in or on the human body.
The updates highlight the strict distinction between medical purpose and cosmetic, pharmacological, or purely environmental functions. Manufacturers must provide robust scientific evidence of the principal mode of action to ensure correct regulatory qualification.
Source:
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