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Regulations


TÜV Rheinland

Whatever your position in the company or in the supply chain is, you strive to ensure constant safety, quality as well as compliance for your people, products, services or management systems. Whether from our headquarters in Cologne, Germany, or anywhere in the world through our extensive network of offices and laboratories, we are active in all major industrial sectors and areas of life. As an independent service provider, our experts test, monitor, inspect, develop, assess and certify products, equipment, processes and management systems. We also train people in a wide range of professions and fields.

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.

TÜV Rheinland LGA Products GmbH is a Notified Body for the EU Medical Devices Regulation (MDR) 2017/745

Medical Device Regulation (MDR) 2017/745

The European Medical Devices Regulation 2017/745 (MDR) came into force on May 25, 2017 and will replace the two Directives 93/42/EEC (MDD) and 90/385 EEC (AIMDD) by May 26, 2020.
Starting immediately, you may submit your application for MDR certification.

New Regulations for Medical Products

pdf New IVDR 1 MB Download
pdf New MDR 1 MB Download
pdf FAQ on the new European Medical Device Regulation (MDR) 362 KB Download
pdf MDR / IVDR declaration of interest 46 KB Download

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