Borderline device Classification
Introduction
Classification of borderline product (cosmetics VS medical device)
Our client, a multinational cosmetics and wellness product
manufacturer identified revenue opportunities marketing their
cosmetics devices with increase claims. Apotech was engaged
to perform a blanket regulatory assessment of cosmetic
devices and provide judgement and pathways for market
authorisation as a medical device
Standards & Tools
- ISO 13485
- ISO 22716
- EU MDR
- GDPR
- Word Excel, Powerpoint
Scope of work
Provide regulatory analysis of
cosmetics device versus medical
device for US, EU and APAC markets
Consulting and training on the
implications and expectations of
medical device classification
Device ‘classification’ and associated
market authorisation pathway
Main outcome
- Medical device classification
conclusion for 3 of 7 products - Engaged project planning and market analysis to justify sales as a medical device
- End client pursuing medical device designation due to market
Key numbers
Team
2 SMEs with more than 15 years experience
Location
Remote and Worldwide
Length
1-2 weeks per product
Type
Work Package
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