On 14 January 2022, the European Commission published a draft Implementing Regulation laying down the Common Specifications for the groups of products without an intended medical purpose that are listed in Annex XVI of the Medical Device Regulation (“MDR”). The proposal would establish technical and clinical requirements that these products must fulfil to demonstrate compliance with the MDR. Through these Common Specifications, the Implementing Regulation paves the way for the upcoming regulation of a wide range of aesthetic products which have not been consistently regulated throughout the EU. The draft act is open for feedback until 11 February 2022.
The regulation of products without a medical purpose is in motion
The entry into application of the MDR on 26 May 2021 brought a number of regulatory changes and challenges to placing medical devices on the EU market. However, medical devices were not the only category of products impacted by the MDR. Groups of products which do not have a medical purpose but present similar characteristics and risks to medical devices are also included within the scope of the MDR. These groups of products without a medical purposes are listed in Annex XVI of the MDR. Annex XVI currently includes a broad range of aesthetic devices such as cosmetic lenses, dermal fillers, liposuction equipment and cosmetic lasers. Additional products may be added to the Annex in the future.
In the absence of the required related Common Specifications, the MDR is not yet applicable to products without a medical purpose. The Regulation will only apply to the groups of products listed in Annex XVI once Common Specifications have been established for these products. The Common Specifications are intended to provide a set of technical and clinical requirements on the basis of which conformity with the requirements of the MDR can be demonstrated.
The European Commission expects to adopt the Common Specifications for the groups of products listed in Annex XVI in the third quarter of 2022. The Common Specifications will apply six months after the date of their entry into force. The date of application of the Common Specifications will also be the date on which the MDR begins to apply to the groups of products listed in Annex XVI of the MDR.