MedTech Europe submission to ECHA public consultation: REACH Annex XV restriction report on Microplastics

Dear members,

We would like to ask for your urgent support regarding a public consultation on microplastics which will close next Friday, 20 September.

The consultation requests for input from stakeholders on the potential impact of a new REACH restriction proposal on microplastics. The current proposal would ban the use of all microplastics in IVDs, unless the microplastics are fully contained during the entire life cycle of the product, and any microplastics-containing waste is disposed of as hazardous waste.

Only very few comments were submitted to the public consultation so far which relate to (IVD) medical devices. We therefore encourage you to submit your own comments before 20 September, by replying to question 4:

You will find MedTech Europe’s position paper attached. Further background is provided below. For questions, do not hesitate to contact Nathalie Buijs (

Thanks for your support and best regards,

Nathalie Buijs

Background: Potential impact of REACH restriction proposal on microplastics on the IVD sector

Microplastics are widely used in IVD reagents and our understanding is that especially for high-volume, automated IVD instruments using such reagents, it is not feasible to ensure full containment of microplastics including disposal of all microplastics-containing waste, some of which is currently disposed of down the drain as part of the system wastewater.

The restriction proposal foresees a transition period of 2 years for IVD manufacturers to make adjustments, which is considered as highly insufficient by MedTech Europe. Moreover, it would lead to huge costs to redesign devices and lab/hospital infrastructure, which is disproportionate to the extremely low release of microplastics from the medical technology sector to the environment.

MedTech Europe has therefore requested a complete exemption for medical devices and IVDs from the scope of this restriction, to avoid that medical technology products would no longer be available to healthcare systems in Europe.

Nathalie Buijs | Manager Regulations and Industrial Policy
Mob. +32 496 92 58 78