One of the most significant expansions of scope under MDR compared to the old Medical Device Directives is the inclusion of certain products that have no intended medical purpose but pose similar risks to medical devices. These products are listed in Annex XVI of MDR, and they are now subject to the regulation even though they are not used for diagnosis, treatment, or any other medical purpose.

This expansion was driven by a simple logic: if a product poses the same risks to users as a medical device, it should be regulated to the same safety standard — regardless of whether the manufacturer claims a medical purpose.

For startups building products in the aesthetic, wellness, or lifestyle space that involve technology traditionally associated with medical devices, Annex XVI is essential reading. It may pull your product into MDR territory even though you never intended to make a medical device.

What Annex XVI Covers

Annex XVI lists six groups of products without an intended medical purpose that are nonetheless subject to MDR:

Group 1: Contact Lenses or Other Items Intended to Be Introduced Into or Onto the Eye

Decorative colored contact lenses are the classic example. They have no medical purpose — they do not correct vision — but they are placed directly on the eye and pose the same risks as corrective contact lenses (corneal abrasion, infection, hypoxia).

Group 2: Products Intended to Be Totally or Partially Introduced Into the Human Body Through Surgically Invasive Means for the Purpose of Modifying the Anatomy or Fixation of Body Parts

This covers products like breast implants used for cosmetic (non-reconstructive) purposes, dermal fillers for aesthetic enhancement, and other surgically implanted products used for body modification rather than medical treatment.

Group 3: Substances, Combinations of Substances, or Items Intended to Be Used for Facial or Other Dermal or Mucous Membrane Filling by Subcutaneous, Submucous, or Intradermal Injection or Other Introduction

Dermal fillers, lip fillers, and similar injectable products used for aesthetic purposes. These products carry risks of tissue damage, vascular occlusion, infection, and granuloma formation — the same risks as when similar products are used for medical purposes.

Group 4: Equipment Intended to Be Used to Reduce, Remove, or Destroy Adipose Tissue

Non-medical fat reduction devices. Cryolipolysis machines, radiofrequency fat reduction devices, laser lipolysis equipment — when marketed for aesthetic body contouring rather than medical treatment. The technology is the same, the risks are the same, but the intended purpose is cosmetic rather than medical.

Group 5: High-Intensity Electromagnetic Radiation (e.g., Infrared, Visible Light, and Ultraviolet) Emitting Equipment Intended for Use on the Human Body, Including Coherent and Non-Coherent Sources, Monochromatic and Broad Spectrum, Such as Lasers and Intense Pulsed Light Equipment, for Skin Resurfacing, Tattoo or Hair Removal, or Other Skin Treatment

Aesthetic laser and intense pulsed light (IPL) devices. Hair removal lasers, tattoo removal lasers, skin rejuvenation devices — when used for non-medical aesthetic purposes. These devices can cause burns, scarring, eye injury, and skin damage.

Group 6: Equipment Intended for Brain Stimulation That Apply Electrical Currents or Magnetic or Electromagnetic Fields That Penetrate the Cranium to Modify Neuronal Activity

Non-medical brain stimulation devices. This group reflects the emergence of consumer neurotechnology — devices marketed for cognitive enhancement, mood modification, meditation assistance, or gaming rather than treatment of neurological conditions. The risks of applying electrical currents or electromagnetic fields to the brain are the same regardless of whether the purpose is medical or not.

How Annex XVI Devices Are Regulated

Annex XVI devices are subject to MDR's requirements, but with an important mechanism: the European Commission adopts Common Specifications for each product group that define the specific requirements those products must meet.

The Common Specifications for Annex XVI devices are set out in Commission Implementing Regulation (EU) 2022/2346.

These Common Specifications address: - Risk management requirements specific to each product group - Clinical evaluation requirements (including how to demonstrate safety when there is no therapeutic benefit to weigh against risks) - Labeling and information requirements - Post-market surveillance requirements

The Application Date for Annex XVI

The Common Specifications for Annex XVI devices were adopted with specific application dates, giving manufacturers time to bring their products into compliance.

Classification of Annex XVI Devices

Annex XVI devices are classified using the same Annex VIII classification rules as medical devices. A decorative contact lens, for example, is classified as an invasive device in contact with the eye — the same classification rules that apply to corrective lenses. An implantable aesthetic product follows the classification rules for implantable devices.

This means that many Annex XVI devices end up in Class IIa, IIb, or even Class III — requiring Notified Body involvement for conformity assessment.

Conformity Assessment

The conformity assessment routes are the same as for medical devices of the corresponding class. A Class IIb aesthetic laser device follows the same Annex IX conformity assessment as a Class IIb medical laser device. A Class III cosmetic breast implant follows the same conformity assessment as a Class III reconstructive breast implant.

The Notified Body assessing the device must have the appropriate designation scope for the product type.

Impact on Startups

If You Are Building an Aesthetic Device

If your startup is developing a product in any of the six Annex XVI categories, you need to plan for full MDR compliance. The regulatory path is essentially the same as for a medical device of the same risk class.

This means: - Full QMS per Article 10(9) / ISO 13485 - Complete technical documentation per Annex II - Clinical evaluation demonstrating safety - Risk management per ISO 14971 - Notified Body involvement (for most Annex XVI devices, given their typical classification) - Post-market surveillance and vigilance - EUDAMED registration - UDI implementation

The timeline and cost estimates from our previous posts on CE marking apply. An aesthetic device is regulated to the same standard as a medical device.

The Clinical Evaluation Challenge for Annex XVI Devices

Clinical evaluation for Annex XVI devices presents a unique challenge: there is no medical benefit to demonstrate. For medical devices, the clinical evaluation framework is built around the benefit-risk balance — you demonstrate that the clinical benefits outweigh the risks. For Annex XVI devices with no medical purpose, there is no therapeutic benefit.

The Common Specifications address this by requiring that the clinical evaluation demonstrate that the risks are acceptable considering the nature of the product and its intended use. Since there is no medical benefit, the acceptable risk threshold is effectively lower — users are accepting physical risks for aesthetic or lifestyle purposes, and the regulation recognizes this asymmetry.

This means your clinical evidence strategy needs to focus heavily on safety — demonstrating that the risks are minimized and that the residual risks are acceptable given the non-medical intended use.

If Your Device Straddles the Line

Some devices could be marketed as either medical or non-medical. A laser device for skin treatment could be positioned as a medical device (for dermatological conditions) or as an aesthetic device (for cosmetic skin rejuvenation). Both paths lead to MDR regulation — one as a medical device under the core regulation, the other as an Annex XVI device under the Common Specifications.

The choice of intended purpose affects: - Your clinical evaluation approach (benefit-risk for medical, risk acceptability for aesthetic) - Your marketing claims (medical claims vs. aesthetic claims) - Your market access (medical devices may be reimbursable; aesthetic devices typically are not) - Your commercial positioning

Tibor's guidance: "If your device has both medical and aesthetic applications, you need to decide your primary intended purpose early. You can always expand later — adding a medical indication to an aesthetic device, or vice versa — but that requires updating your conformity assessment. Start with the purpose that makes the most strategic sense for your business and your evidence base."

The Market Implications

Annex XVI has fundamentally changed the competitive landscape in the aesthetic device market. Before MDR, many aesthetic devices were sold in the EU without any medical device regulation. Now, they must meet the same regulatory standards as medical devices.

For startups, this creates both challenges and opportunities:

Challenge: Higher regulatory barriers mean higher costs and longer timelines to market for aesthetic devices. Smaller companies that previously operated without regulation now face significant compliance investments.

Opportunity: The regulatory barrier acts as a quality filter. Products that meet MDR standards demonstrate a level of safety and quality that unregulated products cannot match. For startups willing to invest in compliance, the CE mark (or rather, MDR conformity) becomes a powerful differentiator in a market that was previously undifferentiated on safety.

Opportunity: Companies with existing medical device regulatory expertise can leverage that competence into the aesthetic market. If you already have an ISO 13485-certified QMS and experience with MDR conformity assessment, expanding into Annex XVI products is an incremental effort, not a ground-up build.

Enforcement and Transition

Market surveillance authorities are responsible for enforcing Annex XVI requirements. Given that many products in these categories were previously unregulated, enforcement has been a transition process — authorities are working to identify non-compliant products and bring them into the regulatory fold.

For startups entering the market now, the expectation is clear: comply from the start. Do not wait for enforcement actions against competitors to motivate your own compliance. The transition period is over (or ending), and the regulatory expectation is full compliance.

The Bottom Line

Annex XVI reflects a fundamental principle of MDR: regulation should follow risk, not intended purpose. If a product poses the same physical risks as a medical device, it deserves the same regulatory scrutiny — regardless of whether the manufacturer calls it medical or aesthetic.

For startups in the aesthetic, wellness, or consumer neurotechnology space, this means taking MDR seriously even if you never intended to be in the medical device business. The regulation has come to you. The companies that embrace it — building safe, well-documented products that meet rigorous standards — will build sustainable businesses. The companies that ignore it or try to work around it will face enforcement actions, market withdrawal, and reputational damage.

The regulation is not going away. Build accordingly.