Annex XVI devices are devices without a medical intended purpose that are within the scope of the MDR. In the past two years, there have been a number of regulations, common specifications and guidance documents that have been published regarding these devices. This article is intended to explain the current state of play of these devices with regard to classifications, transitional provisions and common specifications.
Scope
Currently, Annex XVI of the MDR encompasses 6 groups of devices. These groups along with examples of devices within each group are tabulated below;
| Device Group | Examples |
| Contact lenses or other items intended to be introduced into or onto the eye. | Coloured Contact Lenses |
| 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 with the exception of tattooing products and piercings. | Cosmetic breast implants |
| 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, excluding those for tattooing | Dermal Fillers |
| Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty. | Laser/Cryogenic/Ultrasound |
| High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) 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 | Hair removal, aesthetic lasers /equipment |
| Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain. | Transcranial stimulation (non-invasive) |
Classification
With regard to the classification of Annex XVI devices, they are classified using the classification rules set out in Annex VIII of the MDR, similarly, accessories to Annex XVI devices will be classified in their own right. That being said, Rule 9 and Rule 10 of the MDR make reference to active devices that have a medical intended purpose (Rule 9 – Active therapeutic devices, Rule 10 -Active devices intended for diagnosis and monitoring) and therefore cannot be applied to active devices without a medical intended purpose. Some exceptions which are highlighted in (EU) 2022/2347 had to be made to cater for the classification of active Annex XVI devices without a medical intended purpose. According to regulation (EU) 2022/2347, the following active devices without a medical intended purpose will be reclassified:
- High intensity electromagnetic radiation emitting equipment without an intended medical purpose, intended for use on the human body for hair removal will be classified as Class IIa
- High intensity electromagnetic radiation emitting equipment without an intended medical purpose, intended for the use on the human body for skin treatment will be classified as Class IIb
- Equipment intended to be used to reduce, remove or destroy adipose tissue will be classified as Class IIb
- Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain will be classified as Class III
Transitional Periods of Annex XVI Devices
Firstly, we would like to point out that there are no transitional provisions for Annex XVI devices that do not require the involvement of a notified body and such devices must comply with the MDR as from the date of application of (EU) 2022/2346, which is 22nd June 2023 (6 months after the date of publication of (EU) 2022/2346, 22nd December 2022).
The transitional periods are only applicable for Annex XVI devices that under the MDR require the intervention of a notified body. According to (EU) 2022/2346, the transitional periods are as follows:
- 31st December 2029, for manufacturers who intend on performing a clinical trial, that being said, for manufacturers to be eligible for this deadline, they would need to have signed a written agreement with a notified body by 1st of January 2028.
- 31st December 2028, for manufacturers who do not intend on performing a clinical trial, that being said, for manufacturers to be eligible for this deadline, they would need to have signed a written agreement with a notified body by 1st of January 2027.
Specific Requirements for Annex XVI Devices Highlighted in (EU) 2022/2346
Annex I of the common specifications includes the general requirements for all the products covered by Annex II to Annex VII and addresses the following topics:
- Risk Management (very closely mirrors the requirements of the ISO 14971 standard).
- Information Provided by the Manufacturer
- Labels
- Instructions for Use
- Production and Post-production Activities
- Information for Safety
The following Annexes (Annex II-VII) detail more specific requirements for risk management and information for safety for specific groups of devices.
- Annex II common specifications for contact lenses.
- Annex III common specifications for products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy, with the exception of tattooing products and piercings.
- Annex IV common specifications for 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, excluding those for tattooing.
- Annex V common specifications for equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
- Annex VI common specifications for high intensity electromagnetic radiation (for example, infra-red, visible light and ultra-violet) 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.
- Annex VII common specifications for equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.
The Common Specifications highlight the specific hazards that manufacturers must consider for each device type. This regulation also considered specific risk control measures that the manufacturer must take into consideration. In addition to this, they specify the specific information for safety that needs to be included on the information provided by the manufacturer, namely the label and IFU for these devices.
Below, we will discuss some examples found in Annex II concerning contact lenses.
Specific Risks
Taking a look at Annex II, the first section that is discussed is specific risks for this group of devices. The document references various risks stemming from the following:
- Design and Manufacturing: for example, the shape of the device, in particular in view of avoiding irritation by edges or sharps.
- Distribution chain: for example, lack of pre-testing of suitability lens wearing performed by ophthalmologists.
- User-related hazards/risks: for example,lack of experience with and training on the use of contact lenses of certain uses;
Specific risk control measure
The next subsection discusses the specific control measures that manufacturers should consider for these devices. Some examples from this section concerning contact lenses can be seen below;
- The field of vision shall not be reduced by the lens
- All materials of the lens and the inner side of its primary packaging, including its storage solution, shall be biocompatible, non-irritating and non-toxic
- Lenses and the inner side of their primary packaging, including its storage solution shall be sterile and nonpyrogenic.
Information for Safety
The next subsection discusses the information for safety that should be displayed on both the label and IFU. Some examples from this section concerning contact lenses can be seen below;
Label
- where devices are intended for single use, in addition to the internationally recognized symbol, in bold font of largest used size on the label the text “Do not re-use
- indication of the dimensions of the lens (outer diameter of the lens and base curve radius);
Instructions for Use
- in bold font of largest used size in the instructions the text: “Do not re-use”, in addition to the internationally recognized symbol, where devices are intended for single use
- a warning “Used lenses shall not be used by other persons”;
- the indication of the dimensions of the lens (outer diameter of the lens and base curve radius);
Guidance Documents
As of the time of writing this article, there have been two guidance documents that have been published concerning Annex XVI devices. They provide clarification on certain concepts relating to Annex XVI devices.
- MDCG 2023-5: Qualification and Classification of Ann XVI Devices
- MDCG 2023-6: Demonstration of Equivalence for Ann XVI Devices
Looking at MDCG 2023-5: Qualification and Classification of Annex XVI Devices, we can see a clarification to the following:
- Accessories of Annex XVI devices
- Reclassification of Active devices without a medical intended purpose (discussed above)
Looking at MDCG 2023-6: Demonstration of Equivalence for Ann XVI Devices we can see a clarification on the claiming of equivalence in the following circumstances:
- Device without a medical intended purpose Vs. Device without a medical intended purpose
- Device without a medical intended purpose Vs. Analogous Medical Device
- Device without a medical intended purpose Vs. Dual Purpose Device
Useful Links
The documents that were used and referenced in this article can be seen below:
| Document Name | Reference |
| (EU) 2022/2346 | https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R2346 |
| (EU) 2022/2347 | https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R2347 |
| (EU) 2023/1194 | https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R1194 |
| Q&A on transitional provisions for products without an intended medical purpose covered by Annex XVI of the MDR | https://health.ec.europa.eu/system/files/2023-09/md_new-reg_annex-xvi_q-n-a_transition-prov.pdf |
| MDCG 2023-5: Qualification and Classification of Ann XVI Devices | https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-5_en.pdf |
| MDCG 2023-6: Demonstration of Equivalence for Ann XVI Devices | https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-6_en.pdf |
