Medical devices without a medical purpose: how MDR regulates aesthetic and non-medical products

Introduction

Medical devices are typically associated with diagnosing, treating, or preventing diseases. However, some products that do not have an intended medical purpose but function similarly to medical devices and pose similar risks are also regulated under the Medical Device Regulation (MDR) (EU 2017/745). These include aesthetic and cosmetic products, such as contact lenses, dermal fillers, and body modification implants.

To ensure safety and risk management, the MDR requires these products to comply with many of the same regulatory requirements as traditional medical devices. This article explores how non-medical devices fall under MDR, what regulatory obligations apply, and how manufacturers can achieve compliance.

Why are non-medical devices covered under MDR?

The EU recognizes that certain aesthetic and cosmetic devices function in the same way as medical devices and pose comparable risks to users. Because of their similar technology and potential hazards, the MDR includes them in Annex XVI, ensuring they are subject to safety and performance requirements.

For example, contact lenses worn for cosmetic reasons pose the same risks to the eye as prescription contact lenses. Similarly, dermal fillers, although used for aesthetic purposes, carry risks such as infection, tissue damage, and allergic reactions, just like medically indicated injectables. Lasers and intense pulsed light (IPL) devices used for hair removal or skin resurfacing can cause burns and other side effects, similar to their medical counterparts.

To prevent unsafe products from entering the market, the MDR imposes regulatory controls on these products—despite their lack of a medical purpose.

What types of non-medical devices are covered?

Annex XVI of the MDR outlines six categories of products that are covered under the regulation, despite having no intended medical purpose. These include:

• Contact lenses or other items placed in or on the eye (cosmetic lenses).
• Surgically invasive implants for modifying anatomy or fixing body parts (except piercings and tattooing).
• Dermal and mucous membrane fillers (such as hyaluronic acid fillers).
• Devices used for fat reduction, such as liposuction or lipolysis equipment.
• High-intensity light-based devices, including lasers and IPL for skin treatments, hair removal, and tattoo removal.
• Brain stimulation devices that use electrical or electromagnetic fields to alter neuronal activity.

Even though these products are not medical devices in the traditional sense, their potential risks justify regulatory oversight similar to medical devices.

What does compliance look like for these products?

Since these products are not intended for medical treatment, they do not need to demonstrate a clinical benefit in the same way as medical devices. However, manufacturers must still prove that the product is safe and performs as intended.

This means compliance involves:

• Risk management – Manufacturers must assess and mitigate potential risks, just as they would for medical devices.
• Common specifications (CS) – The European Commission establishes specific requirements for safety and risk management for each product group.
• Clinical evaluation – Instead of proving a medical benefit, manufacturers must demonstrate product safety. Clinical investigations are required unless equivalent safety data exists from analogous medical devices.
• Post-market surveillance (PMS) – Manufacturers must monitor adverse events, complaints, and device performance once the product is on the market.

How manufacturers can demonstrate compliance

To legally market these devices in the EU, manufacturers must work with a Notified Body and follow an MDR-compliant conformity assessment process. This includes:

• Applying common specifications – The European Commission develops CS for each category, outlining how manufacturers should conduct risk assessments and safety evaluations. These CS are mandatory once published.
• Conducting clinical evaluations – Instead of proving medical efficacy, manufacturers must demonstrate device safety through clinical investigations or equivalent safety data.
• Risk-based approach – Manufacturers must follow ISO 14971 (Risk Management for Medical Devices) to minimize potential harm to users.
• Establishing a quality management system (QMS) – An ISO 13485-compliant QMS is required to ensure consistent safety and performance.
• Post-market clinical follow-up (PMCF) – Even after the device is on the market, manufacturers must actively monitor for safety issues and report adverse events to regulatory authorities.

Expanding the scope: future regulatory changes

The MDR allows the European Commission to expand the list of non-medical devices if new risks emerge. If a product has similar risks to an existing medical device, the Commission can add it to Annex XVI through delegated acts.

This means that manufacturers of new aesthetic technologies—such as wearable brain stimulators or AI-driven beauty devices—should stay prepared for possible regulatory inclusion under MDR.

Conclusion: what manufacturers need to know

Although products without a medical purpose may seem outside the scope of MDR, the similarities in technology and risks make regulatory oversight essential. Manufacturers of aesthetic and cosmetic devices must comply with risk management, safety evaluations, and post-market monitoring—just like medical device manufacturers.

As MDR enforcement continues, strict compliance will be key for market access in the EU. Manufacturers should closely monitor regulatory updates, ensuring their devices meet evolving requirements while maintaining consumer trust and safety.

Would you like guidance on developing a compliance strategy for your specific product? Contact us.