According to the EU MDR Regulation, Appendix I General Safety and Performance Requirements (GSPR) Article 10.4 regarding CMR/EDCs substances:

The design and manufacture of medical devices should minimize the risk caused by substances or particles (including swarf, degradation products, and processing residues, etc.) that may be generated by the device. These substances mainly refer to CMR and EDCs substances.

CMR Substances

CMR refers to Category 1A or 1B Carcinogenic, Mutagenic, or Reprotoxic substances, which can be identified according to Annex VI Part 3 of Regulation (EC) No 1272/2008 (commonly known as the CLP Regulation).

EDCs Substances

EDCs stand for Endocrine Disrupting Chemicals, which are external chemicals that can disrupt human endocrine functions.

EDCs can be identified according to the procedures set out in Article 59 of Regulation (EC) No 1907/2006 (also known as the REACH Regulation).

MDR Requirements for CMR/EDCs

1.High-risk devices include:

• Invasive devices that come into direct contact with the human body (e.g., orthopedic implants, ear thermometer probes);
• Drug/bodily fluid delivery devices (e.g., breathing tubes, infusion pumps);
• Drug storage and transport devices (e.g., syringes, infusion bags).

2.Limits and labeling:

• If the concentration of CMR (Categories 1A/1B) or EDCs exceeds 0.1%, the substance name and content must be labeled on the device and packaging;
• For sensitive groups such as children/pregnant women, the instructions must additionally explain the residual risks and preventive measures.

Enterprise Response Methods

Manufacturers should communicate thoroughly with notified bodies to assess whether their products comply with CMR requirements. If compliance is necessary, they should:

Based on their knowledge of the product, combined with the manufacturing process and environment, product formulation, etc., identify potential CMR/EDCs substances (this task may require extensive process and product experience), define a testing scope, which may be much smaller than the list of CMR substances and EDCs substances, and then commission a testing organization to issue a test report.

If some substances exceed 0.1%, analyze and judge the potential exposure of patients or users to these substances using independent research, equivalent evaluation studies, scientific opinions from relevant scientific committees, etc., and analyze possible alternative substances, materials, or designs, as well as the availability of these alternative materials, to justify the presence of such CMR/EDCs substances, aiming to prove that the material is irreplaceable and that the benefit-risk ratio for potential patients or users is acceptable.

This evaluation process and test results, as a research report, along with other TD files, should be submitted to the NB organization during registration for review.

Advanced Compliance Measures

During the manufacturing process, manufacturers should communicate thoroughly with material suppliers and establish a comprehensive chemical management system from the design stage of the medical device, implementing it throughout the entire lifecycle of the medical device product. For different materials used in medical devices, the risks of potential substances should be assessed from the early stages of product design and development, seeking professional testing or consulting organizations for planning and advice, to help evaluate whether the product/components comply with the chemical substance requirements of various regulations.

CIRS Testing CMR and EDCs Substance Screening Service Advantages:

✅ Comprehensive Screening: Covers all high-risk substances (about 2000 types) listed in the EU CLP Regulation (CMR Categories 1A/1B/2) and REACH Regulation (EDCs identification procedures), accurately identifying common toxic and harmful components such as nickel, asbestos, bisphenol A, phthalates, etc.

✅ Compliance Guidance: According to MDR Annex I 10.4.1 requirements, customized testing plans are provided for high-risk devices (invasive/drug contact types) to ensure content ≤0.1% or scientific exemption justification.

✅ Full Process Support: From the product design stage, assistance in establishing a chemical management system, covering raw material procurement → production → finished product testing throughout the entire lifecycle, reducing compliance risks.

✅ Labeling and Reporting: Provides MDR-compliant test reports and labeling recommendations, including substance name and concentration list, helping enterprises to pass EU audits quickly.

If you need any assistance or have any questions, please get in touch with us via test@cirs-group.com.