Classification Borderline: What Constitutes a Medical Device?
Distinguishing a medical device from a cosmetic, biocide, or drug is complicated when a product seems to fit the definitions for two or more product types. These products are often referred to as borderline or combination products. In this white paper, we discuss:
- The Manual on Borderline and Classification
- How to regulate a combination product with characteristics of a medical device and a drug
- The definition of medical device combination products
- Special medical devices (cosmetic/aesthetic devices)
- and provide example cases of borderline products and their correct classification.
About the Author
Dr. Jaap Laufer MD, PharmD: Dr. Jaap Laufer MD, PharmD is Vice President of Regulatory & Clinical Affairs at Emergo. Dr. Laufer has over 30 years of experience in the medical device and pharmaceuticals industries. He previously held executive and senior regulatory positions at Pfizer, Abbott Laboratories, LipoMatrix, and others. His areas of expertise include a vast array of mostly implant and higher classed products, ISO and FDA QSR audits, and clinical study approvals and compliance. He holds a PharmD in Pharmacy from the University of Groningen and is an MD from the Medical School of the Univ ersity of Nijmegen, both in The Netherlands. Dr. Laufer is a member of the Medical Devices Expert Group to the EU Commission and teaches at the University of Southern California in Los Angeles, USA.