List of Common Specifications under Annex XVI – EU MDR
On December 01, 2022, the European Commission published common specification for the group of products listed under Annex XVI of EU Medical Device Regulation – EU MDR as ‘products without an intended medical purpose.’
2 publications were posted under the same headline where one of them talk about the final statements, comments and recommendations for these products and this one lists down the common specifications. Our experts have cut through the maze and published a shorter version for Medical/Borderline Medical Device Manufacturers.
The latest 34 page publication has 7 annexes.
- Annex 1 lists down general RISK Management requirements for all devices/products listed in this groups.
- Manufacturers shall establish and document responsibilities, operative modalities and criteria for the execution of the risk management process.
- Top-level management of the manufacturers shall ensure that adequate resources are allocated and that competent personnel is assigned for risk management.
- The personnel responsible for performing risk management tasks shall be appropriately qualified.
- Throughout the entire lifecycle of a device, the manufacturer shall establish a system to ensure a continuous systematic update of the risk management process in relation to that device.
- Where the risk is acceptable, risk control is not needed and the final estimated risk shall be considered as a residual risk.
- Manufacturers shall ensure that the information for safety is not limited to the instruction for use or to the label, but also available by other means. Information integrated in the device itself that the user cannot disregard and public information easily accessible to the user shall be considered. Where appropriate, user training shall be considered. The information shall be presented taking into account the degree of understanding of users and consumers.
- The label shall bear the words “non-medical purpose:” followed by a description of that non-medical purpose
- The Annex II applies to contact lenses listed in Section 1 of Annex XVI to Regulation (EU) 2017/745 Medical Device Regulation. Contact lenses containing tools, such as antenna or microchip, contact lenses which are active devices and other items intended to be introduced into or onto the eye are not covered by this Annex. Further Risk Management and Safety requirements are mentioned for the manufacturers.
- Annex III applies to products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy, listed in Section 2 of Annex XVI to Regulation (EU) 2017/745. Tattooing products, piercings and products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of fixation of body parts are not covered by this Annex. This Annex does not apply to active implantable devices.
- Annex IV applies to 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, listed in Section 3 of Annex XVI to Regulation (EU) 2017/745. This Annex only applies to the means for introduction into the body, for example syringes and dermarollers, where they are prefilled with the substances, combinations of substances or other items listed in Section 3 of Annex XVI to Regulation (EU) 2017/745. This Annex does not apply to active devices.
- Annex V applies to equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty, listed in Section 4 of Annex XVI to Regulation (EU) 2017/745. This Annex does not apply to active implantable devices.
- Annex VI applies to high intensity electromagnetic radiation (for example infrared, 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, listed in Section 5 of Annex XVI to Regulation (EU) 2017/745. For the purposes of this Annex, skin resurfacing includes skin rejuvenation. For the purposes of this Annex, tattoo removal includes removal of permanent makeup. For the purposes of this Annex, other skin treatments include non-medical treatment of nevi flammei, haemangioma, teleangiectasia, pigmented skin areas, and scars that are not injury within the meaning of Article 2, point (1), second indent, of Regulation (EU) 2017/745. For example, this Annex applies to devices intended to treat acne scars, but it does not apply to devices for other acne treatment. This Annex does not apply to equipment using infrared optical radiation to warm the body or parts of the body and to sunbeds.
- Annex VII applies to 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 as listed in Section 6 of Annex XVI to Regulation (EU) 2017/745. Such equipment includes devices for transcranial alternating current stimulation, transcranial direct current stimulation, transcranial magnetic stimulation and transcranial random noise stimulation. This Annex does not apply to invasive devices.
Manufacturers need to ensure that their products are defined appropriately with relevant intended purposes. A wrong intended purpose can take your device from being a wellness product to being a high-risk medical devices which need robust QMS, Regulatory compliance and Post Market vigilance.
Your time and resources are precious. Talk to an expert right from the start and avoid unwanted hassle. Remember – A Non complaint Medical Product/device can be taken-off the market and manufacters may face serious punishments, penalties and fines!
Protect yourself and your MedTech products for the safety of the patients. We are here to be your Regulatory Risk Partners for Medical Devices, Diagnostics and Digital Health.
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