EU Medical Device Regulation Update to Add 50 Substances by 2028
Event summary
- The EU is updating its Medical Device Regulation (EU MDR) to include 40 new Carcinogens, Mutagens, and Reproductive Toxicants (CMRs) and 10 new allergens by 2028.
- The updates stem from Adaptation to Technical Progress (ATP) of the CLP regulation, with 11 new CMRs under ATP 23 and 29 under ATP 24.
- Standard EU MDR sensitization tests are ineffective for detecting the 10 newly classified allergens.
- Claigan Environmental Inc. is hosting two webinars on April 8, 2026, to address these changes.
- Compliance requires adjustments to device labeling, instructions for use, and technical files.
The big picture
The EU's ongoing updates to the MDR demonstrate a heightened focus on chemical safety and patient well-being within the medical device sector. This regulatory tightening will disproportionately affect smaller manufacturers lacking dedicated compliance teams and specialized testing capabilities. The need for specialized testing and material substitutions will likely increase the cost of bringing medical devices to market within the EU.
What we're watching
- Regulatory Headwinds
- The sheer volume of new substances (50 total by 2028) will likely strain internal compliance resources for medical device manufacturers, potentially impacting product launch timelines and increasing operational costs.
- Testing Bottlenecks
- The ineffectiveness of standard sensitization tests for the new allergens suggests a need for specialized testing, which could create bottlenecks and delays in device certification processes.
- Supply Chain Impact
- The identification of 'at-risk materials and components' will force device manufacturers to re-evaluate their supply chains, potentially leading to material substitutions and increased sourcing complexity.
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