The EU Medical Devices Regulation (MDR) not only regulates medical devices, but also products without a medical purpose , e.g. B. Devices for liposuction, breast implants or colored contact lenses.

In December 2022 - four and a half years after the MDR was published - the EU regulated the necessary details with two implementing regulations (2022/2346 and 2022/2347).

The following sources are particularly relevant for manufacturers of these products:

  • MDR Annex XVI
  • Common Specifications: Implementing Regulation (EU) 2022/2346 in the Official Journal (DE)
  • Classification: Implementing Regulation (EU) 2022/2347 for the reclassification of rules 9 and 10 for Annex XVI products (DE)

This article provides manufacturers of non -medical devices ( Annex XVI devices ) with an overview of the regulatory requirements that they have to observe and gives tips on how to implement them.

1. Products covered by Annex XVI

The MDR lists six product groups in Appendix XVI.

# Product group Examples 1 Contact lenses or other articles intended for insertion into or onto the eye Colored contact lenses 2 Devices intended to be wholly or partially inserted into the human body by surgically invasive procedures for the purpose of modifying anatomy or fixing body parts Subdermal implants such as horn implants, breast implants 3 Substances, combinations of substances or articles intended for use as facial or other dermal or mucosal fillers by subcutaneous, submucosal or intracutaneous injection or other types of Introduction are intended, with the exception of those for tattoos dermal fillers, e.g. B. hyaluron syringes 4 Devices intended to reduce, remove or break down fat tissue, such as devices for liposuction, lipolysis or lipoplasty Body-forming devices, e.g. for liposuction 5 Devices intended for application to the human body emitting high-intensity electromagnetic radiation (infrared, visible, ultraviolet), coherent and non-coherent light sources, and including monochromatic and broadband spectrum light, such as lasers and intensely pulsed light working devices for removing the upper layers of the skin ("skin resurfacing"), for tattoo or hair removal or other forms of skin treatment IPL devices for hair removal or skin rejuvenation; does NOT apply to sun loungers 6 Devices for transcranial stimulation of the brain using electrical current or magnetic or electromagnetic fields to change neuronal activity in the brain Non-invasive devices for magnetic or electrical stimulation of the brain (without specific medical purpose)

In the future, the EU Commission may expand this list through delegated legal acts (implementing regulations) and add new product groups. However, the prerequisite is that these are similar to corresponding medical devices due to the risk profile or due to features or their functionality.

2. Requirements for products without a medical purpose a) Almost the same requirements apply as for medical products

The short version is: The requirements for products without a medical purpose are (almost) the same as the requirements for "normal" medical devices.

The MDR even includes medical devices, accessories and products without a medical purpose under the term

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