MDR

The EU Medical Device Regulation (Regulation (EU) 2017/745, MDR) includes chemical substance requirements mainly in Annex I, Section 10.4.1 related to design and manufacturing. In general, to understand the chemical requirements of the MDR, one must first understand CMR and EDC substances.

CMR is an abbreviation for three terms: Carcinogenic, Mutagenic, and Reprotoxic substances. Because CMR substances pose chronic hazards, they are subject to restrictions. Currently, there are thousands of listed CMR substances, and the list continues to expand. They are classified as:

• CMR: 1A (proven to cause the above three effects in humans).
• CMR: 1B (animal studies indicate possible effects on humans).
• CMR: 2 (literature suggests possible effects on humans).

EDCs refer to Endocrine-Disrupting Chemicals. These substances are external chemicals that interfere with the endocrine system in the human body. Once introduced into the environment, some synthetic chemicals can enter the human body or other organisms through the food chain. Due to their molecular structure mimicking natural hormones, they can interfere with physiological regulation processes such as hormone production, release, transport, metabolism, binding, or elimination. Scientific evidence shows that these substances may have serious impacts on human health.

The MDR has been fully effective since May 26, 2021. Chemical substance requirements are specified in Annex I, Section 10.4, which requires that medical devices be designed and manufactured to minimize risks from CMR/EDC substances. Testing data for CMR/EDC substances is required for risk assessment of the following types of devices:

The concentration of CMR/EDC substances must be below 0.1%.

• If the concentration exceeds 0.1%, manufacturers must clearly label the CMR/EDC substances on the device and packaging.
• If such devices are intended for special populations (e.g., pediatric use, pregnant or breastfeeding women, or other sensitive patient groups), residual risk and precautionary information must be included in the instructions for use.

MDR compliance requirements are independent of RoHS, REACH, and POPs. Medical devices placed on the EU market that contain electrical components must comply with all applicable regulations. Non-electrical medical devices are not subject to RoHS. Therefore, compliance with REACH and RoHS is a basic requirement, and for devices covered under MDR Annex I 10.4.1, additional CMR/EDC testing is required.

• For devices under MDR Annex I 10.4.1, Notified Bodies require CMR 1A, 1B, and EDC test reports and related risk assessment documentation.
• RoHS, REACH, POPs, WEEE, and PPW regulations are mandatory for EU market access. Manufacturers must provide self-declaration based on supply chain risk management, material analysis, or testing reports. Products are also subject to customs inspections and market surveillance by EU authorities.

SGS recommends the following best practices for medical device manufacturers:

• Communicate with material suppliers to establish a comprehensive chemical management system from the product design stage throughout the product lifecycle.
• Seek professional testing and consulting services from SGS for different material classifications to evaluate compliance with chemical regulatory requirements.