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Regulations


TÜV Rheinland

Since 1872, we have stood for safety and quality for the people, the environment and technology. Benefit from our wide range of services, expert support and areas of expertise especially designed for your product or company. Our experts offer tailored solutions on the basis of statutory regulations or your own specifications, as well as other relevant performance benchmarks and standards.

Medical Device Safety and Testing at a Glance

Medical Device Regulation (MDR) 2017/745

Start here. - Check the newest regulations, certificate transition dates, and common FAQs for in vitro diagnostic and medical device requirements. Are you prepared for EU, US and key market approval?

New Regulations for Medical Products

pdf New IVDR 1 MB Download
pdf MDR / IVDR declaration of interest 46 KB Download
pdf Regulation (EU) 2017/745 1 MB Download
pdf Regulation (EU) 2020/561 522 KB Download
pdf Medical Device Regulation FAQ 320 KB Download

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