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Medical Device Certification

Enter global markets by complying with applicable medical device certification standards

The global medical device market is governed by a broad range of national and international regulations and medical equipment certification standards

These regulatory requirements are complex and vary between regions, which can make it challenging to gain medical approval for your products in your target market.

TÜV SÜD has in-depth knowledge and experience of medical device certification standards around the globe and can provide advice and guidance to ensure you receive medical approval for your devices in key global markets.

For more information on medical device certification, read TÜV SÜD’s medical device market access guides via the links below.

 

RESOURCES TO HELP YOU LEARN MORE ABOUT MEDICAL DEVICE CERTIFICATION

UKCA Requirements for Medical Device Manufacturers
Webinar

UKCA Requirements for Medical Device Manufacturers

General guidance on the UKCA conformity assessment process

Learn More

IVDR Overview White Paper
White paper

IVDR Overview

Explore the In Vitro Diagnostic scope and definitions as well as the manufacturer requirements

Learn More

The New Medical Device Regulation (MDR)
Infographics

The New Medical Device Regulation

Extended transition period ends on May 26, 2024 for devices with valid MDD/AIMDD certification

Read More

VIEW ALL RESOURCES

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