Borderline and Classification Work Group – Introduction - TOPRA

Manual of Decisions Content
3. Borderline medical device – medicinal product
– Product for testing patient reflex cough
– Elastoviscous fluids
– In-Vitro Fertilisation (IVF) and Assisted Reproductive Technologies
(ART) products
4. Borderline medical device – biocides
– Hand disinfectants
5. Borderline medical device – cosmetic products
– Introduction
6. Accessory to a medical device or in vitro diagnostic medical device
– Haemodialysis water test strips
– Surgical instrument decontamination products
– Dental Water Line Disinfectants
The Organisation for Professionals in Regulatory Affairs
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