Medical Devices – Latest Updates

Regulation (EU) 2017/745 lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union.

The common specifications laid down in this Regulation cover the requirements set out in the second sentence of Section 1 and in Sections 2 to 5, 8 and 9 of Annex I to Regulation (EU) 2017/745.

The common specifications laid down in Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices cover the requirements set out in the second sentence of Section 1 and in Sections 2 to 5, 8 and 9 of Annex I to Regulation (EU) 2017/745. The Regulation lays down common specifications for all groups of products in Annex XVI of the MDR without an intended medical purpose and for products of the following groups in particular:

• contact lenses;
• products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy, with the exception of tattooing products and piercings;
• 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;
• equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty;
• high intensity electromagnetic radiation (for example, 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;
• 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.

Following the July 2022 joint request by certain Member States for the reclassification of several active products without an intended medical purpose, the European Union has now published the Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the reclassification of groups of certain active products without an intended medical purpose. The implementing regulation reclassifies devices, high intensity electromagnetic radiation emitting equipment intended for use on the human body for skin treatment, intended to be used to reduce, remove or destroy adipose tissue, or intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.