CMR / Endocrine Disrupting Substances

MDR Reference: Annex I, GSPR 10.4.1
Service Item ID: mdr_sec06_cmr_endocrine
Applicability: Devices containing CMR or endocrine-disrupting substances above 0.1% w/w

Overview

MDR GSPR 10.4.1 requires specific justification and labelling for devices containing substances that are carcinogenic, mutagenic, or toxic to reproduction (CMR) or have endocrine-disrupting properties, when present above 0.1% weight by weight (w/w).

Key Requirements

Identification

• Screen all device materials for CMR substances (EU CLP Regulation categories 1A/1B)
• Screen for substances on the REACH Candidate List of SVHCs (Substances of Very High Concern)
• Screen for endocrine-disrupting substances (per EU criteria)

Justification (if substance retained)

• Exposure estimation: Route, duration, dose calculation
• Alternatives analysis: Available substitute materials and their feasibility
• Substitution justification: Why the substance cannot be replaced
• Benefit-risk assessment: Benefits of keeping the substance vs. risks of exposure

Labelling

• Substances present above 0.1% w/w must be disclosed on the device label and/or IFU
• Per MDR Annex I, GSPR 10.4.1(c)

Key Deliverables

Document	Description
Substance Identification Report	Screening of all CMR/ED substances > 0.1% w/w
Exposure Assessment	Route, duration, and dose of patient/user exposure
Alternatives Analysis	Evaluation of substitute materials
Substitution Justification	Rationale for retaining the substance
Labelling Update	Device label and IFU disclosure

GSPR Mapping

GSPR	Requirement
10.4.1	CMR and endocrine-disrupting substances identification and justification

Key References

• EU CLP Regulation (EC) 1272/2008 -- Hazard classification criteria
• REACH Regulation (EC) 1907/2006 -- SVHC Candidate List
• SCENIHR guidance on biocompatibility, phthalates in medical devices

Related Topics

• Biocompatibility -- Chemical risk assessment overlaps
• Absorbed / Dispersed Substances -- Substances entering the body