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Services for Non-Active Medical Devices


TÜV Rheinland

In a medical setting, it is not only the high-tech equipment that makes a difference to positive outcomes. Non-active medical devices also have a crucial role to play and are held to equally high standards when it comes to safety and compliance. As a manufacturer of non-active medical equipment, you strive to fulfill the expectations of health care professionals as well as the authorities in charge of regulating your products. Our services can help you meet these expectations. With experts in the field active around the globe, we enable you to demonstrate the safety and reliability of the devices you manufacture, and at the same time to inspire confidence in your customers.

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 92 KB Download
pdf Regulation (EU) 2017/745 1 MB Download
pdf Regulation (EU) 2020/561 522 KB Download

Our portfolio

EU Medical Devices Directive MDR 2017/745
EU Medical Device Regulation MDR 2017/745 

Supporting access to European markets for medical devices under MDR 2017/745.

Artificial Intelligence for Products
Artificial Intelligence for Products 

A guide for understanding the impacts of the EU AI ACT on Products

EN ISO 13485 Certification
EN ISO 13485 certification of QMS for medical devices | TÜV Rheinland  

Certify your Quality Management System (QMS) for medical devices

In Vitro Diagnostic Medical Device Regulation (IVDR)
In Vitro Diagnostic Medical Device Regulation (IVDR) 

Comprehensive services to ensure IVDR compliance for your in vitro medical devices.

Approvals for Greater China
Approvals for Greater China 

We provide comprehensive approval and certification services for fast entry to Greater China market.

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