MDR Annex XVI Guide

Annex XVI Aesthetic Devices Under MDR: Certification Guide (2026)

Q: What products are covered by MDR Annex XVI?

MDR Annex XVI covers six groups of products with no intended medical purpose: (1) contact lenses or other items intended to be introduced into or onto the eye; (2) products intended to be totally or partially introduced into the human body via surgically invasive means for the purpose of modifying the anatomy or fixation of body parts (except tattoo products and piercings); (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; (4) equipment intended to be used to reduce, remove or destroy adipose tissue, such as liposuction, lipolysis or lipoplasty equipment; (5) high intensity electromagnetic radiation emitting equipment intended for use on the human body, including infrared, visible light and ultraviolet, such as lasers and intense pulsed light equipment; (6) equipment intended for brain stimulation that applies electrical currents or magnetic or electromagnetic fields that penetrate the cranium.

Q: Do Annex XVI devices need a Notified Body?

Yes. All products listed in MDR Annex XVI require involvement of a Notified Body in the conformity assessment process, similar to Class III medical devices. This is because despite not having a medical purpose, these products carry significant safety risks that justify third-party assessment.

Q: When did MDR Annex XVI become applicable?

MDR Annex XVI became applicable from 22 March 2020 (the MDR date of application was 26 May 2021, but Article 1(2) covering Annex XVI products applies from the MDR entry into force). Common specifications for Annex XVI products are published by the European Commission and serve as the technical framework manufacturers must comply with.

Q: Do Annex XVI devices need clinical data?

Yes. MDR requires that Annex XVI devices demonstrate an acceptable benefit-risk profile. Clinical data may be required, though the nature and extent depends on the specific product group and associated risks. The applicable Common Specifications define the minimum data requirements for each Annex XVI group.

MDR Annex XVI brings aesthetic and cosmetic devices with no medical purpose under the same rigorous regulatory framework as medical devices. If your product modifies anatomy, fills tissue, destroys fat, or uses high-intensity light or electromagnetic energy on the body — this guide is for you.

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What Is MDR Annex XVI?

Article 1(2) and Annex XVI of EU MDR 2017/745 extend the scope of the Medical Device Regulation to cover certain products that have no intended medical purpose but present similar risks to medical devices due to how they interact with the human body.

These products were previously largely unregulated at the EU level — falling between cosmetics (which don't interact with the body in the same invasive way) and medical devices (which have a declared medical purpose). Annex XVI closes this regulatory gap.

The key principle: if your product is similar in nature and risk profile to a medical device, even if its purpose is purely aesthetic, it falls under MDR Annex XVI and must comply with the applicable MDR requirements and Common Specifications.

💡 Common Specifications are the technical framework The European Commission publishes Common Specifications (CS) for each Annex XVI product group. These define the minimum safety, performance, and clinical data requirements that manufacturers must meet. The CS for Annex XVI products was published as Commission Regulation (EU) 2022/2346 and its amendments.

The Six Product Groups Covered by Annex XVI

1 — Contact lenses & eye products

Items introduced into or onto the eye for purely aesthetic purposes (e.g. decorative coloured lenses with no vision correction).

2 — Implants & anatomical modification

Products totally or partially introduced via surgical means to modify anatomy or fix body parts. Includes aesthetic implants (breast, buttock, etc.).

3 — Dermal fillers & injectable substances

Substances for facial or dermal filling by subcutaneous, submucous or intradermal injection. Includes hyaluronic acid fillers used for cosmetic augmentation.

4 — Fat reduction equipment

Equipment for liposuction, lipolysis, or lipoplasty. Intended to reduce, remove or destroy adipose tissue.

5 — High-intensity EM radiation equipment

Lasers, intense pulsed light (IPL), and infrared/UV equipment used on the human body for aesthetic purposes (hair removal, skin resurfacing, tattoo removal).

6 — Brain stimulation equipment

Equipment applying electrical currents or electromagnetic fields that penetrate the cranium for non-medical purposes (transcranial stimulation, neurofeedback).

Key Regulatory Requirements for Annex XVI Devices

Manufacturers of Annex XVI products must comply with many of the same MDR obligations as medical device manufacturers:

Notified Body involvement is mandatory

Unlike simple low-risk medical devices, all Annex XVI products require a Notified Body in the conformity assessment process. This is because the Commission determined that the risks posed by these products justify third-party oversight, regardless of the absence of a medical purpose.

The applicable conformity assessment procedures are similar to those for Class III medical devices — typically Module H (full quality assurance) or Module B + Module E or F.

Compliance with Common Specifications

Instead of Essential Requirements linked to specific medical purposes, Annex XVI products must meet Common Specifications (CS) published by the European Commission. The CS address:

General safety and performance requirements applicable to the product group
Minimum performance characteristics and testing methodology
Clinical data requirements and post-market surveillance obligations
Labelling requirements specific to the product group

Technical documentation

A full technical documentation file under MDR Annex II must be compiled, covering: product description and specifications, risk management (ISO 14971), clinical evaluation, post-market surveillance plan, and labelling/IFU.

EU Authorised Representative (for non-EU manufacturers)

Non-EU manufacturers of Annex XVI products must appoint an EU Authorised Representative under MDR Article 11, in exactly the same way as medical device manufacturers. The AR is named on the label and in the EU Declaration of Conformity.

EUDAMED registration

Annex XVI products must be registered in EUDAMED. Both the manufacturer/AR and the product must be registered.

Post-market surveillance

An ongoing post-market surveillance system is required, including a post-market clinical follow-up (PMCF) plan or justification for not conducting PMCF, and periodic safety update reports (PSURs).

Transition and Compliance Timeline

Many Annex XVI products that were on the EU market before MDR entered into force are in a transition period. The situation is complex:

Products that were not previously regulated (e.g. purely aesthetic fillers, fat reduction devices) had no pre-existing certificates to grandfather in
The Common Specifications for Annex XVI products define the date from which manufacturers must demonstrate compliance
Products must comply with MDR and the applicable CS before being (or continuing to be) placed on the EU market

⚠ Market surveillance is actively targeting Annex XVI products National competent authorities across the EU are increasingly targeting aesthetic clinics and manufacturers of laser, IPL, and filler products that are not compliant with MDR Annex XVI. Do not assume that existing non-regulated status protects you.

How to Start Your Annex XVI Compliance Project

Confirm your product group — verify which of the six Annex XVI groups your product falls into, and whether it might also qualify as a medical device (in which case different rules apply)
Obtain the applicable Common Specifications — Commission Regulation (EU) 2022/2346 and its amendments are your technical framework
Engage a regulatory consultant — Annex XVI is a relatively new and complex area; expert guidance from the start avoids costly errors
Select and engage a Notified Body — capacity is limited; start early
Build technical documentation — risk management, clinical data, performance testing per CS requirements
Apply for NB assessment — submit application with supporting documentation
Appoint EU AR if non-EU manufacturer — mandatory before placing on market

Need an MDR Annex XVI Compliance Partner?

Submit your request on ECP. We match aesthetic device manufacturers with regulatory consultants, Notified Bodies, and EU Authorised Representatives who specialise in Annex XVI compliance.

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Frequently Asked Questions

What products are covered by MDR Annex XVI?

Six groups: (1) aesthetic contact lenses, (2) implants for anatomical modification, (3) dermal/injectable fillers, (4) fat reduction equipment, (5) high-intensity light/laser equipment for aesthetic use, (6) brain stimulation equipment.

Do Annex XVI devices need a Notified Body?

Yes — all Annex XVI products require Notified Body involvement in conformity assessment, similar to Class III medical devices.

When did MDR Annex XVI become applicable?

MDR Annex XVI applies under MDR 2017/745. Common Specifications have been published that define specific compliance dates and technical requirements for each product group.

Do Annex XVI devices need clinical data?

Yes. The applicable Common Specifications define clinical data requirements. An acceptable benefit-risk profile must be demonstrated based on clinical evaluation and, where required, post-market clinical follow-up.