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Placing medical devices in the EU, Switzerland, and the UK involves navigating distinct regulatory landscapes, with added considerations for RoHS compliance. The EU mandates MDR compliance and CE marking, alongside RoHS directives restricting hazardous substances in electrical and electronic equipment. Switzerland necessitates Swissmedic registration and a Swiss Authorized Representative, while also adhering to its own RoHS-like regulations, despite recognizing CE marks. The UK demands UKCA marking and MHRA registration, with its own RoHS requirements, and transitional periods for CE marked devices. Manufacturers must meticulously adhere to each region's specific medical device and RoHS requirements, including conformity assessments, registration processes, the appointment of authorized representatives, and the restriction of hazardous materials, while staying updated on evolving regulations.

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Placing medical devices in the EU, Switzerland, and the UK requires navigating distinct regulatory landscapes. The EU mandates MDR compliance and CE marking, Switzerland necessitates Swissmedic registration and a Swiss Authorized Representative despite recognizing CE marks, and the UK demands UKCA marking and MHRA registration, with transitional periods for CE marked devices. Manufacturers must meticulously adhere to each region's specific requirements, including conformity assessments, registration processes, and the appointment of authorized representatives, while staying updated on evolving regulations.

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