The REACH Restriction of D4/5/6 was published in the EU Official Journal on 17 May 2024. It will enter into force 20 days from the date of publication.
This marks the end of the legislative process for the regulation of this substance under the Restriction route. The following derogations requested by MedTech Europe have been granted:
- The new transitional period of 7 years for medical devices and IVDs (point 3.c)
- Derogations for both medical device and IVD applications (points 4.b, 4.d; points 5.3.c & 5.3.d)
This information is kindly provided by MedTech Europe.