COSMETICS, aesthetic, wellness AND beauty

Unlocking Market Access for Health, Wellness & Beauty Technologies

Navigating Compliance with Confidence

Many aesthetic, beauty and wellness products fall under the EU Medical Device Regulation (MDR) – even when they do not have a medical purpose.

For manufacturers of products such as dermal fillers, energy-based devices, and skin penetration technologies, MDR Annex XVI introduces new expectations. These relate to safety, clini-cal evidence, and how the product is managed across it’s lifecycle.

At GBA Key2Compliance, we support manufac-turers in bringing these products to market – and keeping them there.

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 aesthetic, beauty and wellness 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
Products already on the market often need to be updated to meet MDR Annex XVI requirements. In practice, this often means:

revisiting the product’s classification rationale and regulatory strategy,
strengthening technical documentation and quality system alignment,
ensuring appropriate safety documentation
building clinical evidence to support claims, and
establishing a workable post-market setup to maintain CE marking.

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 Health, Wellness & Beauty companies avoid unnecessary
work, identify the fastest compliant route, and build
a strategy that stands up to regulatory scrutiny.”

Clinical Development and Evidence for Health, Wellness & Beauty Technologies 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

We help you generate the clinical evidence need-ed to support your claims, demonstrate safety and performance, and enable CE marking and market access.

We work with products such as:

Dermal and mucous membrane fillers
Devices for skin resurfacing, tattoo removal or fat reduction using light (including IPL), laser, radio- frequency (RF) or mechanical action
LED and red-light therapy devices, as well as other energy-based technologies (such as RF or electri-cal stimulation) used for aesthetic or skin treat-ments
Contact lenses and eye-colouring devices

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 management
Biostatistics
Safety and data management
Monitoring
Medical writing

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 aesthetic, beauty and wellness product 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