As part of its plastics strategy, the European Commission has adopted measures under Regulation (EC) No. 1907/2006 (“REACH”) to limit the release of microplastics to reduce environmental pollution and protect human health. These measures affect various sectors, including the medical device industry.
What manufacturers of medical devices need to know now:
With the expiration of the designated transition periods, neither microplastics nor products to which microplastics have been intentionally added and which are released during use may be placed on the market. Under No. 78 of Annex XVII of REACH, the European Commission adopts a broad interpretation of the term "microplastics" in favour of environmental and health protection, encompassing synthetic polymer microparticles with a dimension of ≤ 5 millimetres or a length of ≤ 15 mm with a length-to-diameter ratio greater than 3. Both synthetic polymer microparticles as such and mixtures containing synthetic polymer microparticles at a concentration of 0.01 weight percent or more are covered by the ban.
- For medical devices, the microplastic ban applies with a transition period of six years, effective from 17 October 2029. If synthetic polymer microparticles are used as abrasive substances, i.e., for peeling, polishing, or cleaning (also referred to as microbeads), the ban applies immediately. In the meantime, manufacturers must ensure that their products and processes comply with the new regulations by the end of the transition period and that safe use is guaranteed.
- Additionally, manufacturers of medical devices falling within the scope of these restrictions will be required to fulfil extensive reporting and information obligations starting from 2026 or 2027. They are required to submit to ECHA by 31 May each year a description of the uses of synthetic polymer microparticles in the previous calendar year. This includes general information on the identity of the polymers used and their function in the products. Furthermore, manufacturers must provide specific information about the polymers contained in the products to the relevant authorities upon request. This includes detailed reports on the identity and function of the polymers in the respective products.
What manufacturers of in-vitro diagnostics need to know
Although the microplastic ban does not apply to in-vitro diagnostics, manufacturers of in-vitro diagnostics are subject to strict control measures to ensure environmental protection.
From 17 October 2025, manufacturers and suppliers of in-vitro diagnostics are required to publish detailed instructions for the proper use and disposal of these products. These instructions are intended to prevent the release of microparticles into the environment and must be made accessible to both commercial users and the general public.
From 2027, suppliers must also submit comprehensive annual reports to the relevant authority, including information on the end uses of the products from the previous year and the identity of the synthetic polymers used.
