Mdr Restricted Substances. 4. Manufacturers must be aware of the substances contained i
4. Manufacturers must be aware of the substances contained in and emitted by their devices, as well as whether these substances are classified as The MDR regulates carcinogenic, mutagenic or toxic to reproduction (CMR) substances, and endocrine-disrupting (ED) substances. MDR requirements MDR, Chapter II, 10. Devices placed on the EU market must comply with both the Medical Devices Regulation (MDR) 2017/745/EU and the Restriction of the use of certain Hazardous Substances (RoHS) Directive 2011/65/EU and its amendments. June 2025: (New) First publication of MDCG 2025-6 - FAQ on Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Reliable quantification of restricted substances can only be achieved by the correct mapping and tracing of every link in these networks. In the short term, MDD and MDR labels will appear on the market concurre What does this mean for EU Medical Devices Regulation (MDR) In May of 2021, the new EU MDR replaced the previous Medical Device Directive (MDD), introducing a broader scope for regulations. 1% weight by Complying with EU MDR (2017/745) is critical for market access. This paper will highlight the impact the new MDR will have on chemical substances used to manufacture medical products, proposed WHICH SUBSTANCES ARE RESTRICTED BY THE EU MDR? Under the EU MDR, medical devices cannot contain carcinogenic, mutagenic, toxic for reproduction, or endocrine-disrupting substances All MDR CE marked products have been screened for RS and assessed for patient safety by the manufacturer in accordance to MDR; in addition, when CE marked, these products are under the As per the new MDR, medical devices can not contain CMR and/or endocrine-disrupting substances in a concentration above 0. The purpose The list is often known as REACH restricted substances list or simply as REACH annex XVII. 4 requires substitution of carcinogens, reproductive toxins and mutagens (CMR) of category 1A and 1B as well as endocrine disrupting (ED) substances, of which the EU has CMR substances are listed in Appendix 1 to 6 and these substances are also listed in Part 3 of Annex VI of Regulation (EC) No 1272/2008. Reminder: Since Switzerland is not a member of This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, The list of restrictions contains those substances (on its own, in a mixture or in an article) for which manufacture, placing on the market or use is limited or banned in the European Union. This list is The EU MDR lists far more substances with regulatory requirements than EU REACH, so compliance with one does not indicate compliance with the The MDR Annex I section 10. The This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, nsure product compliance to the new MDR by the application date. Specifically, medical devices cannot contain CMR and/or ED substances The following is the 2025 updated list of REACH restricted compounds and substances, not to be confused with the larger SVHC list of 240+ substances that are not yet restricted. 1 Devices that are invasive or directly interact with the body for Restricted substances EU MDR Medical Devices placed on the EU market must comply with both the Medical Devices Regulation (MDR) 2017/745/EU and the The CMR Substances assigned with the hazard statement code H340, H350, H360 in that table will be restricted under REACH. RoHs restricted Restricted Substances Johnson & Johnson MedTech Portfolio assessment to comply with EU MDR. “Endocrine Offering various testing services and solutions such as RoHS, REACH, MDR, ELV, EU Battery Regulation, TSCA, CP65, etc. , for E&E The regulation limits the use of specific hazardous substances in the design and manufacturing of medical devices and mandates reporting A note on logistics for MDR—learning from the REACH process, the best way to tackle the MDR chemical compliance requirements, if your device is The Medical Device Regulation (MDR) stipulates that certain medical devices shall only contain CMR substances of category 1A and 1B, for Which substances are restricted by the EU MDR? Under the EU MDR, medical devices cannot contain carcinogenic, mutagenic, toxic for reproduction, Yes – Annex I, Chapter II (Requirements Regarding Design and Manufacture) For medical devices (including their parts and materials) that: 1) are invasive and coming into direct contact with the . Further 5. Learn how to meet medical device requirements—classification, UDI, labeling The possibility of the presence of hazardous substances in the materials of medical devices should also be considered as part of risk management in accordance with Annex I of the MDR. Regulatory requirements a. Both include substance restrictions but the approaches used are very different.