Annex XVI and EU MDR – Guide to regulation of products without intended medical purpose
Products without an intended medical purpose might also be governed in Europe under Regulation (EU) No. 2017/745 on medical devices (EU MDR), i.e. be subject to the requirements of medical devices. Such products include for example dermal fillers, liposuction equipment or non-corrective colored contact lenses, as listed in EU MDR Annex XVI. They are commonly referred to as “Annex XVI products”. If you are unclear whether your product falls under EU MDR Annex XVI or if you wish to understand what requirements apply to an Annex XVI product, read on.
- Even though the scope of the EU MDR is driven by a medical device intended purpose, it applies also to specific groups of products without medical purpose, as listed in EU MDR Annex XVI.
- Products without medical purpose might also have no medical benefit. Therefore, EU MDR requirements concerning the benefit/risk ratio are substituted by requirements on safety and performance.
- The same quality management system (QMS), PRRC qualification and conformity assessment requirements apply both to the products with or without medical purpose.
- Some products without medical purpose are classified differently than the corresponding devices with medical purpose.
What are “Annex XVI products”?
Annex XVI of Regulation (EU) No. 2017/745 on medical devices (EU MDR) includes a list of 6 types of products that are governed by the EU MDR despite lacking an intended medical purpose.
The EU Commission considered that those groups of products for which the manufacturer claims only an aesthetic or another non-medical purpose but which are similar to medical devices should be covered by the EU MDR, due to the fact that they are similar to medical devices in terms of functionality and risk profile. Indeed, the individual on whom such products are used is taking risks without objective evidence of respective benefits, and should be protected similarly to a patient. Hazards could stem from:
- Surgical procedure (anesthesia, infection, bleeding, access, closure, healing/scar)
- Tissue contact (permanent or temporary) of foreign body or substance
- Modification or removal of tissue
- Administration of energy
The EU MDR refers to these products as “devices”, which basically equates them with medical devices, albeit as a special category within medical devices.
The table below shows the list of product groups listed in Annex XVI together with some product examples:
1. Contact lenses or other items intended to be introduced into or onto the eye.
Colored contact lenses
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 with the exception of tattooing products and piercings.
Solid body contour modifying implant (e.g. breast implants)
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, excluding those for tattooing.
4. Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
Body shaping equipment
5. 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.
Intense pulsed light (IPL) equipment (e.g. for hair removal)
6. 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 equipment (surgically non-invasive) for non-medical purposes
Per EU MDR Art. 1(5), the EU Commission is empowered to adopt delegated acts that would amend the list in Annex XVI by adding new groups of products.
What happens to “Annex XVI products” that also have a medical purpose?
As Annex XVI devices do not have a medical purpose, they are normally not required to demonstrate clinical benefit, only safety and performance. For example, contact lenses for changing the color of eyes would not need to demonstrate clinical benefit.
However, should the Annex XVI product also have a medical purpose, such as corrective colored contact lenses, then clinical benefit must also be demonstrated. Devices with both medical and non-medical purposes must fulfill all requirements cumulatively.
How are “Annex XVI products” classified?
In general, Annex XVI products are classified in accordance with the classification rules in Annex VIII of the EU MDR. Accessories to Annex XVI products also fall under the EU MDR and, per Annex VIII Chapter II 3.2, they shall be classified in their own right.
The classification rules 9 and 10 in EU MDR Annex VIII refer to an intended medical purpose, i.e. therapy and diagnosis, respectively, which cannot be applied to active products without an intended medical purpose. Therefore, there are some exceptions, which are documented in Regulation (EU) 2022/2347 on the reclassification of Annex XVI products that are considered to be active devices.
Per Regulation (EU) 2022/2347, the following groups of Annex XVI active devices are reclassified:
- High intensity electromagnetic radiation emitting equipment intended for the use on the human body for skin treatment is class IIb, unless it is intended for hair removal only in which case it is class IIa.
- Equipment intended to be used to reduce, remove or destroy adipose tissue is 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 is class III.
Do manufacturers of “Annex XVI products” need a Quality Management System (QMS)? Does the QMS need to be certified by a Notified Body?
According to EU MDR Article 10 (9) manufacturers of devices, other than investigational devices, shall “establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device.” This QMS requirement applies to Annex XVI products, as they are comprised under the term “devices” throughout the EU MDR.
«Manufacturers of Annex XVI products must have a Person Responsible for Regulatory Compliance.»
«Manufacturers of Annex XVI products must have a Person Responsible for Regulatory Compliance.»
The EU MDR requires the same conformity assessment procedures for Annex XVI products as for other medical devices. The conformity assessment is driven by the device’s risk class, which is determined according to the rules in EU MDR Annex VIII, with the exception of those Annex XVI products reclassified under Regulation (EU) 2022/2347.
Manufacturers of Annex XVI products must have (or have at their disposal) a Person Responsible for Regulatory Compliance (PRRC), in compliance with EU MDR Article 15. The PRRC must have the same qualifications by education and/or experience as required for medical devices.
To learn more about QMS for medical devices, see our blog piece on Certification of a Quality Management System according to ISO 13485.
What EU MDR requirements apply to “Annex XVI products”?
There are very few exceptions to the EU MDR requirements for Annex XVI products.
Any deviations and particular approaches that apply to Annex XVI products are documented in the corresponding Common Specifications (CS) that have been published in Regulation (EU) No. 2022/2346. These include product specific requirements related to risk management, safety requirements and information for safety (i.e. labeling and instructions for use).
Due to the fact that Annex XVI products do not have a medical purpose, they cannot be expected to demonstrate a clinical benefit; only safety and performance requires demonstration.
Per EU MDR Article 61(9), the requirement to demonstrate a clinical benefit shall be understood as a requirement to demonstrate device performance. As such, clinical evaluations for Annex XVI products shall be based on relevant data concerning safety, which includes post-market surveillance data, post-market clinical follow-up data, and, where applicable, clinical trial data. “Clinical investigations shall be performed for those products unless reliance on existing clinical data from an analogous medical device is duly justified.”
Regarding the General Safety and Performance Requirements (GSPR) in Annex I of the EU MDR that all devices must comply with, a specific GSPR (no. 9) is introduced to address how risk-benefit profile should be considered for Annex XVI products. This GSPR #9 indicates that GSPRs #1 and #8 shall be understood to mean that “the device, when used under the conditions and for the purposes intended, does not present a risk at all or presents a risk that is no more than the maximum acceptable risk related to the product’s use which is consistent with a high level of protection for the safety and health of persons”.
Note however, that devices with both medical and non-medical purposes must fulfill all the relevant EU MDR requirements.
For more details on EU MDR compliance, see our blog piece on How to obtain a CE mark for a medical device.
When do manufacturers of “Annex XVI products” need to take action?
Manufacturers should immediately verify if their Annex XVI products may benefit from any transitional periods.
EU MDR was meant to apply to Annex XVI products from the date of application of the Common Specifications (CS), which were published in December 2022 in Regulation (EU) No. 2022/2346. Transitional periods were introduced for certain Annex XVI products.
There are no transitional periods for Annex XVI products that do not require the involvement of a Notified Body under the EU MDR. These devices must comply with the EU MDR from the date of application of Regulation (EU) No. 2022/2346, i.e. 22 June 2023.
For Annex XVI products that need a Notified Body under the EU MDR, whether they were previously CE-marked as medical devices (and hold a valid Notified Body certificate under the MDD) or not, Regulation (EU) No. 2022/2346 introduced the below dates as deadline for the application of the EU MDR. This Regulation is being amended so that the timelines are aligned with the new transitional periods in the EU MDR introduced by Regulation (EU) 2023/607.
- If the manufacturer intends to perform or is performing a clinical trial: originally, 22 June 2028. This deadline is now being extended to 31 December 2029.
However, to benefit from this deadline, from 01 January 2028 the manufacturer shall have signed a written agreement with a Notified Body for the conformity assessment under the EU MDR.
- If the manufacturer does not plan a clinical trial: originally, 22 June 2025. This deadline is now being extended to 31 December 2028.
Similarly as for the previous deadline, from 01 January 2027 the manufacturer shall have signed a written agreement with a Notified Body for the conformity assessment under the EU MDR.
The transitional timelines are subject to conditions, particularly that the Annex XVI product was lawfully marketed prior to 22 June 2023 and that no significant changes be brought to its design and intended purpose.
How Decomplix can help
Decomplix offers consultancy services in all regulatory and quality assurance matters relative to medical devices, with particular focus on the Swiss market and CE marking. We can support your company in fulfilling all the requirements under the EU MDR or IVDR and ensure compliance in the most efficient manner.
In addition, we offer Swiss Authorised Representative services under both the MedDO and the IvDO. Our services include instructions and checklists for your understanding of the applicable requirements.
If you would like to discuss your concerns with us, please do not hesitate to contact us via this form.
- The role of a PRRC under the MDR
- Certification of a Quality Management System according to ISO 13485
- How to obtain a CE mark for a medical device
- Is My Product a Medical Device? Medical Device Definition under MDR
- Intended Purpose Under MDR – What Does Your Medical Device Do?
- “Legacy” medical devices and IVDs under EU legislation – Decomplix