COSMETICS
From Cosmetics to Medical Devices Navigating Compliance with Confidence
Cosmetic and aesthetic products are increasingly falling under the Medical Device Regulation (MDR). The challenge? The regulatory path is complex, not always clear, and requires early planning to avoid costly rework.
At GBA Key2Compliance, we help you understand exactly what applies to your product – and what you need to do to reach and maintain CE compliance efficiently.
Learn how we can support your product from concept to CE marking.
Laying the foundation for compliance and market access
– getting your product classification right is critical
It determines your entire compliance pathway – your documentation, testing requirements, clinical evidence, and approval timeline.
We help cosmetics companies avoid unnecessary work, identify the fastest compliant route, and build a strategy that stands up to regulatory scrutiny.
Borderline products (Annex XVI MDR)
If your product uses laser, light, mechanical abrasion, brain stimulation, or is intended for aesthetic modification (including eye-colouring or fillers), it may qualify as a medical device. Misclassification is one of the biggest causes of delay.
We help you:
• Get a clear MDR classification
• Understand what evidence is required
• Avoid the risk of market withdrawal
• Build a documentation strategy that aligns with your commercial plans
Legacy products
If your product was previously placed on the market under the Cosmetics Regulation or MDD, you may now need:
• Stronger clinical evidence
• Updated risk management
• Updated PMS procedures
• Revised technical documentation
We help you bridge the gap smoothly so you can keep products on the market without interruption.
New or combination products under MDR
Early evidence planning matters. A well-defined strategy reduces cost, avoids duplicate testing, and speeds up approval.
Discuss your product and get
a clear pathway forward
”We help cosmetics companies avoid unnecessary
work, identify the fastest compliant route, and build
a strategy that stands up to regulatory scrutiny.”
Clinical development and evidence for cosmetic products under MDR
Talk to our Clinical Development team about building the right evidence for CE marking.
Clinical evidence is often the biggest hurdle – and the biggest opportunity
Our MedTech-focused CRO helps you design clinical strategies that are both compliant and commercially smart.
We work with products such as:
- Skin-barrier creams
- Scar gels
- Redness-reducing formulations
- Wound-healing sprays
- Dermal fillers
Our clinical services:
- Clinical Strategy & Planning – Ensure the level of evidence matches your claims and market ambitions.
- Clinical Investigations (ISO 14155, MDR) – Designed to deliver robust data, executed efficiently, and managed by specialists.
- Flexible execution model – We select the best-fit sites and investigators for your product type – meaning higher quality data, smoother recruitment, and fewer delays.
You gain a full clinical team, including:
- Clinical project managers
- Biostatisticians
- Data and safety specialists
- Monitoring experts
- Medical writers
We also support all regulatory interactions, claim mapping, and documentation.
Ensuring product safety and biological compliance
– biological safety is non-negotiable under MDR
Our biological safety specialists help you ensure your product meets all requirements — without unnecessary testing or cost.
Our services include:
- Biological evaluation (plan + report)
- Toxicological risk assessment
- Coordination of all required in vitro and chemical tests
We help you:
- Choose the right tests from the start
- Avoid costly over-testing
- Demonstrate safety with confidence
- Build documentation that Notified Bodies accept without delay
Why work with GBA Key2Compliance
We are the partner of choice for cosmetics manufacturers navigating MDR because we offer:
End-to-end expertise
Regulatory, quality, clinical, and biological safety — all in one place.
Tailored strategies
Whether you are a startup or an established global brand, we match the compliance pathway to your goals.
Faster, smoother approvals
We help you avoid common pitfalls, prevent rework, and accelerate
time-to-market.
Strong, practical documentation
Technical files, safety documentation, clinical evidence — built with both regulatory and commercial success in mind.
As part of the GBA Group, you gain access to an international network of specialists and cross-border regulatory insights.
Learn how we can support your product from concept to CE marking
Whether you are:
- Launching a new product
- Managing borderline or Annex XVI products
- Updating legacy documentation
- Building clinical evidence
- Strengthening your biological safety strategy