EU Medical Devices Regulation
日期：2026-07-10 点击：30
Medical Devices Regulation (MDR) is a set of regulations for medical devices in the European Union (EU) to ensure safety, efficacy, and quality. Environmentally related requirements can also apply. Indeed, some strict obligations for device design and manufacturing mandate restricting, labeling, and tracking substances. The EU Database on Medical Devices (EUDAMED) and the Global Unique Device Identification Database (GUDID) are useful for this purpose.
MDR was initially adopted by the EU in 2017 to improve the safety and efficacy of medical devices distributed within the EU. This replaced the 1993 Medical Devices Directive and its amendments. MDR has since been amended by Regulation 2020/561. Moreover, this medical device regulation is a component of the European CE marking requirements, along with other environmental requirements like the EU eco-design and RoHS directives.
MDR sets out new rules for the design, manufacture, and marketing of medical devices, as well as requirements for clinical investigations and post-market surveillance. For example, the MDR requires manufacturers to perform clinical evaluations to demonstrate the safety and performance of their devices before they can be placed on the market. The MDR aims to ensure that medical devices placed on the market are safe, effective, and of high quality while promoting innovation in the medical device industry.
MDR places strict requirements on the design and manufacture of medical devices. Specifically, devices must be designed and manufactured to minimize risks from substances or particles that may be released from the device.
MDR was initially adopted by the EU in 2017 to improve the safety and efficacy of medical devices distributed within the EU. This replaced the 1993 Medical Devices Directive and its amendments. MDR has since been amended by Regulation 2020/561. Moreover, this medical device regulation is a component of the European CE marking requirements, along with other environmental requirements like the EU eco-design and RoHS directives.
MDR sets out new rules for the design, manufacture, and marketing of medical devices, as well as requirements for clinical investigations and post-market surveillance. For example, the MDR requires manufacturers to perform clinical evaluations to demonstrate the safety and performance of their devices before they can be placed on the market. The MDR aims to ensure that medical devices placed on the market are safe, effective, and of high quality while promoting innovation in the medical device industry.
MDR places strict requirements on the design and manufacture of medical devices. Specifically, devices must be designed and manufactured to minimize risks from substances or particles that may be released from the device.
Restrictions of Substances in EU Medical Devices Regulation
MDR restricts the use of certain substances in medical devices under certain conditions. Specifically, devices may only contain certain substances in concentrations above 0.1% w/w if justified. These substances include:
Carcinogenic compoundsMutagenic or toxic substances
Endocrine-disrupting chemicals
Medical device that contains a restricted substance above the specified concentration without justification will not be allowed to be marketed in the EU.NEED A Medical Devices RoHS TEST REPORT?
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