General Safety and Performance Requirements 에서는 위험관리에 대해 다음의  항으로 또한  설명하고 있습니다.

Annex XVI 는 의료목적을 가지지 않는 제품들 (컨택트렌즈, 문신기, 지방제거(분해) 등의  제품에 대해 안내합니다. 자세한 내용은 아래 원문을참조해주시기 바랍니다.

[Annex I General safety and performance requirements]

For the devices referred to in Annex XVI, the general safety requirements set out in Sections 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.

Annex XVI 에 언급된 장치의 경우 1~8 절에 제시된 일반적인 안전 요구 사항은 해당 조건과 목적에 따라 사용될 때 장치가 위험을 전혀 나타내지 않거나 사람의 안전과 건강에 대한 높은 수준의 보호와 일치하는 제품의 사용과 관련된 최대 수용 가능한 위험보다 높지 않다.

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.