Ordinance No. 2022-582 of April 20, 2022 adapting French law to Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017 on medical devices (“MDR”) was published in the Official Journal yesterday. It is partly applicable as of today.
So what changes, for whom, and when?
First of all, two warnings:
- the ordinance does not only concern medical devices(“MD”). It also covers :
o accessories for MD and in vitro diagnostic medical devices (“IVDD”) ;
o other products intended for non-medical use: these include non-corrective contact lenses, wrinkle fillers, slimming devices and certain hair removal devices [1] (“Schedule XVI products”).
- The ordinance does not only address the topics covered by the MDR. The government has taken advantage of this “grooming” of the public health code to modify certain regulations unrelated to the MDR.
That being said, it is difficult to integrate the 18 articles of the ordinance: while some of them read quite well (since they are completely rewritten), others are more complex to grasp.
In addition to this:
- firstly, some products are not covered by the ordinance, for example because of their date of marketing ;
- secondly, the products falling within the scope of the ordinance are in fact only affected by some of its provisions;
- finally, not all of the provisions are immediately applicable.
We therefore propose a first “clearing” of the new provisions in order to allow manufacturers to identify the subjects on which it is advisable to comply now. For more specific questions (in particular on the detailed content of new obligations or details on the date from which they will be applicable), do not hesitate to write to us (contact@gd-associes.com).
To which products does the ordinance apply?
What are the main changes made by the ordinance? Which products are affected by these changes? Are they immediately applicable?
GD Avocats advises manufacturers on the regulation of health and related products.
[1] Exhaustively, the following are covered by Annex XVI of the MDR
- contact lenses or other articles intended to be introduced into the eye or placed on the eye;
- products intended to be totally or partially introduced into the human body by invasive surgical means with a view to modifying the anatomy or fixing anatomical parts, with the exception of tattoo products and piercings;
- substances, combinations of substances or articles intended to fill in the face, skin or mucous membranes by subcutaneous, submucosal or intradermal injection or any other method of introduction, except those intended for tattooing;
- equipment intended to be used to reduce, remove or destroy fatty tissue, such as that intended for liposuction, lipolysis and lipoplasty;
- equipment emitting high intensity electromagnetic radiation (e.g., infrared, visible light, ultraviolet) and intended for use on the human body, including coherent and non-coherent, monochromatic, and broad spectrum sources, such as lasers and intense pulsed light equipment used for skin resurfacing, tattoo removal, hair removal, or other skin treatments;
- equipment for transcranial brain stimulation using electric currents or magnetic or electromagnetic fields to modify neural activity in the brain.
