MDR ANNEX XVI

ANNEX XVI

LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2)

1. Contact lenses or other items intended to be introduced into or onto the eye.

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.

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.

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.

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.

Explanation

MDR also applies to SOME products that do not have an intended medical purpose. This could, for example, be cosmetic implants like lip fillers and liposuction devices. You can find the complete list of products in Annex XVI, as above. And unless otherwise stated in the MDR, the same requirements shall apply to the products that would apply to medical devices.

The date of application for the products above, meaning when they have to meet MDR requirements, is six months after the day Common Specifications or CS for the specific type of device has been published. So, if you are a manufacturer of any of the devices listed in Annex XVI, you need to keep yourself updated on the status of the relevant Common Specifications.

Relevant courses

Find out more about the requirements that apply to products in Annex XVI by registering for the following course:

Relevant templates

N/A

Applicable MDCG guidance documents

Relevant blog posts

YouTube videos

About the author

Pontus Gedda - Medical Device HQ instructor

Pontus Gedda

Pontus Gedda is a dedicated medical device specialist that has worked both in the industry, as a design engineer and project manager, and in the notified body world as a medical device lead auditor and manager.

He has vast experience in the MDR and its implementation through hands-on experience from implementing the MDR at a notified body and leading that notified body through a joint assessment and getting designated as an MDR notified body.

He was a senior manager at a notified body during the transition from MDD to MDR and also a member of the NB-MED group.

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