医疗器械| 医疗器械出口欧盟法规及要求 - 速航船务

Medical Devices | EU Regulations and Requirements for Medical Device Exports

EU MDR core chemical requirements

1. Scope of controlled substances

  • CMR substances (carcinogenic, mutagenic, reproductive toxic):

    • Category 1A : proven to be harmful to humans

    • Category 1B : Animal experiments have shown that it may be harmful

    • Category 2 : Suspected harmful (such as benzene, lead chromate, etc.)

  • EDCs (endocrine disruptors): interfere with the human endocrine system and affect reproductive health.

2. Applicable device types (must meet the requirements of Annex I 10.4.1)

category Example
Invasive direct contact devices Orthopedic implants, ear thermometer probes
Devices for delivering drugs/body fluids Breathing tubes and infusion equipment
Devices for storing drugs/body fluids Fluid storage bags, blood transfusion equipment

3. Limits and special requirements

  • Concentration limit : CMR 1A/1B or EDCs substance concentration ≤0.1% (w/w) .

  • Excessive treatment :

    • Products and packaging must be labeled with the substance name and concentration;

    • If used for sensitive groups such as children and pregnant women, the instructions must warn of the risks and list preventive measures.

4. Relationship with other regulations

Regulations Key control points Association with MDR
RoHS Restriction of Hazardous Substances in Electrical and Electronic Equipment Live medical devices must also comply with
REACH SVHC notification (>0.1% and >1 ton/year) All medical devices must meet REACH obligations
PPW instruction Heavy metal limit for packaging (≤100ppm) Packaging materials must comply with

Key point : MDR’s chemical requirements are independent of RoHS/REACH and require additional CMR/EDCs testing.

5. Transitional Adjustments (Updated in 2023)

Device Type Transition Deadline
High-risk equipment December 31, 2027
Low and medium risk equipment December 31, 2028
Class III implantable custom devices May 26, 2026

Key Actions for Corporate Compliance

  1. Material screening : Ensure that the concentration of CMR/EDCs substances in device materials is ≤0.1%;

  2. Warning for sensitive groups : Supplementary risk description for devices used on children and pregnant women;

  3. Multiple regulations in parallel :

    • Electronic devices are also RoHS compliant;

    • All devices fulfill REACH notification obligations;

    • The packaging complies with PPW heavy metal limits.

  4. Document preparation : Provide CMR/EDCs test reports, substance lists and risk analysis documents.

Summary : The MDR enhances device biosafety by strictly restricting CMR/EDC substances. Companies must conduct targeted testing based on material risk classification and simultaneously comply with cross-cutting regulations such as RoHS and REACH, with particular attention to special labeling requirements for products intended for sensitive populations. The transition period has been extended to 2027-2028, but chemical compliance must be implemented as soon as possible.

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