MDR Annex XVI: What Does the EU Regulation Mean for Cosmetic Devices?
For the first time, cosmetic devices without a medical intended purpose fall under medical device regulation
What is the MDR (Medical Device Regulation)?
The MDR (Regulation (EU) 2017/745) is the European Medical Device Regulation, which has replaced the previous directives (MDD 93/42/EEC and AIMD 90/385/EEC) since May 2021. It governs the placing on the market, surveillance and operation of medical devices throughout the EU.
The MDR introduced numerous tightened requirements: stricter conformity assessments, expanded clinical evaluations, a new vigilance system (EUDAMED) and — particularly relevant for the cosmetics industry — Annex XVI.
Annex XVI: Products without a medical intended purpose
Annex XVI of the MDR represents a paradigm shift in European regulation. For the first time, products that have no medical intended purpose are nevertheless regulated like medical devices. The reason: these products pose risks comparable to medical devices and should therefore be subject to the same safety requirements.
Article 1(2) of the MDR defines six product groups listed in Annex XVI. For the cosmetics industry, the following are particularly relevant:
Which cosmetic devices are affected?
- IPL devices for hair removal and skin rejuvenation (Intense Pulsed Light)
- Laser devices for skin rejuvenation, tattoo removal, hair removal
- Cryolipolysis devices for non-invasive fat reduction
- High-intensity electromagnetic stimulation (e.g. for muscle building)
- Filler injection devices (devices for introducing substances under the skin)
- Non-corrective contact lenses (coloured contact lenses)
Key point: This specifically concerns devices used for cosmetic or aesthetic purposes — i.e. not marketed as medical devices. It is precisely these devices that now fall under MDR regulation for the first time.
Transition periods: What currently applies?
The implementation of Annex XVI was originally planned for 2024 but has been postponed several times. The current status:
| Milestone | Date | Details |
|---|---|---|
| MDR in force | 26.05.2021 | Regulation applies in principle |
| Common specifications published | 2022 | Implementing Regulation (EU) 2022/2346 |
| Transition period for existing devices | 31.12.2028 | Devices that were on the market before the date of application may continue to be operated until then |
| New devices from the date of application | From publication of specifications + 30 months | Must be CE-compliant under MDR |
What does this mean in practice? You may continue to operate existing devices in your studio until the end of 2028. New devices placed on the market after the cut-off date must already meet MDR requirements.
Impact on operators of cosmetic devices
Annex XVI has far-reaching consequences for everyone operating affected devices:
CE marking and conformity assessment
Manufacturers of Annex XVI devices must in future carry out a conformity assessment under the MDR and affix a CE marking. For operators, this means: when purchasing new devices, ensure that the device is MDR-compliant.
MPBetreibV obligations apply
Once a device is classified as a medical device (even without a medical intended purpose), the obligations of the MPBetreibV apply:
- ✓ Section 2 Definitions: The device falls under the extended medical device definition
- ✓ Section 3 Operator obligations: Proper handling, maintenance, training
- ✓ Section 4 General requirements: Only intended use, proper condition
- ✓ Section 7 Maintenance: Regular maintenance and testing per manufacturer specifications, safety test after every repair
No STK obligation — but maintenance obligation
An important distinction: Annex XVI devices generally do not fall under Annex 1 of the MPBetreibV. This means: there is no STK obligation under Section 11. However, the general maintenance and training obligations under Sections 3, 4 and 7 MPBetreibV apply in full.
In addition, DGUV Vorschrift 3 continues to apply, requiring regular electrical safety testing.
Distinction: NiSV vs. MDR Annex XVI
Many operators ask: what is the difference between NiSV and MDR Annex XVI? The answer: they are two different regulatory frameworks that overlap for many devices.
| Criterion | NiSV | MDR Annex XVI |
|---|---|---|
| Regulatory level | National regulation (Germany) | EU regulation |
| Subject matter | Application of non-ionising radiation on humans | Placing on the market and operation of products without medical intended purpose |
| Applies to | The operator (cosmetician) | The manufacturer and the operator |
| Obligations | Professional competence, notification obligation, documentation | CE conformity, operator obligations under MPBetreibV |
| Affected devices | Laser, IPL, RF, ultrasound, EMS, magnetic field | IPL, laser, cryolipolysis, filler injection devices, etc. |
Important: Both regulatory frameworks apply in parallel. An IPL device for hair removal falls under both NiSV (application obligations) and MDR Annex XVI (product obligations). Both frameworks converge at one point: regular device testing.
What does this mean in practice for your studio?
The testing requirements for cosmetic devices are noticeably increasing due to MDR Annex XVI. Even though the transition periods are still running, you should prepare now:
- ✓ Inventory: Which of your devices fall under Annex XVI? Create a list.
- ✓ Manufacturer information: Check whether your manufacturers already offer MDR-compliant versions.
- ✓ Documentation: Start now with structured device documentation (analogous to the medical device log).
- ✓ Regular testing: Have your devices professionally tested to DIN EN 62353 now — this is the best preparation for increasing requirements.
- ✓ New purchases: When buying new devices, ensure MDR conformity and CE marking.
Prepared for Annex XVI
We are equipped with DIN EN 62353 for the testing of Annex XVI devices. Our testing covers electrical safety, which remains a central requirement under the MDR. This ensures you are prepared for increasing testing obligations — starting today.
Summary: The key points
- ✓ MDR Annex XVI regulates cosmetic devices like medical devices for the first time
- ✓ Affected: IPL, laser, cryolipolysis, filler injection devices
- ✓ Transition period for existing devices until 31.12.2028
- ✓ Operator obligations under MPBetreibV apply (Sections 2, 3, 4, 7)
- ✓ No STK obligation, but maintenance and training obligations
- ✓ NiSV and MDR apply in parallel — professional testing satisfies both