What is Annex XVI
The MDR expanded its scope to a new group of devices defined as “products without an intended medical purpose”. This group of products includes devices used for aesthetic indications and dual use products. These devices are regulated by MDR Annex XVI.
To continue being placed on the market, Annex XVI devices must be MDR certified.
Groups Products covered in Annex XVI
To know more on qualification, accessories, dual-purpose devices, and multiple intended purposes devices, explore our resources here below.
How to classify your aesthetic device?
Common Specifications
The role of CS in Annex XVI devices conformity assessment is critical as they provide a harmonized framework guiding manufacturers, while at the same time defining safety and performance requirements their devices must meet. The CS laid down in (EU) 2022/2346 facilitate in the conformity assessment of Annex XVI devices, covering aspects relating to Risk Management and Information for Safety. Generally, Annex XVI devices follow the conformity procedures laid down in MDR Art. 52 according to the identified risk class of the device.
Claiming Equivalence
As per Regulation (EU) 2022/2346, it is not possible to demonstrate equivalence between a medical device and an Annex XVI product in case all available clinical investigations relate only to the medical device. In such instance, clinical investigations should be conducted for products without an intended medical purpose.
See MDCG 2020-5, MDCG 2023-6, MDCG 2020-6 and MEDDEV 2.7/1 rev.4.
Clinical Evaluation Consultation Procedure (CECP)
Annex XVI devices are not exempted from the CECP under MDR Article 54(2)(c).
- A device that has already been placed on the EU market and that is now regulated under MDR Annex XVI may be subject to the CECP.
- A device that has already been placed on the EU market under the MDD/AIMDD (i.e., legacy device), which has dual use, may be exempt from the CECP in respect of the medical intended purpose but not exempt in respect of the non-medical intended purpose; since there is a change to the intended purpose, the exemptions in Article 54(2) do not apply.
Therefore, legacy medical devices that now include a non-medical intended purpose under MDR Annex XVI, will be subject to the CECP in respect to the non-medical intended purpose.
Why choose BSI to certify your aesthetic device?
- World-leading experience and expertise.
- Accepting Annex XVI applications since December 2022.
- Already issued 6 Annex XVI certificates to date.
- > 60 ongoing conformity assessment applications to date for dermal filling, breast augmentation, lipoplasty, bodysculpting, contact lenses, laser hair removal, dermal abrasion and facelift procedures.
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