Services for Active Medical Devices

So much of today’s medical landscape, including diagnostics and all levels of treatment, rely on active medical devices. Active MDD cover all devices requiring a power source other than the body itself or gravity. Lives and health depend on the safe and accurate functioning of such instruments, and your company is dedicated to providing doctors, hospitals and paramedics with life-saving tools of the highest standard. In addition to maintaining a high level of performance internally, this means complying with external directives and regulations set forth by national and international authorities. Well-versed in the intricacies of medical device compliance worldwide, our experts offer services designed to meet your needs. Our laboratories, located across the globe, are among the most sophisticated in the world, and we provide the expertise to match.

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

Acoustics Testing and Measurement

Audiological Testing and Vibration Measurement.

Chemical testing of medical devices

Conformity along the entire supply chain, ensuring the success of your medical devices in all markets.

Approvals for Greater China

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

CB Certificate

CB certification as a globally recognized method for testing the safety of electrical devices.

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

Certify your Quality Management System (QMS) for medical devices

WEEE/RoHS Services

Get Your Electronics Products Compliant with Waste Directives.

Artificial Intelligence for Products

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

Smart Grid Product Testing

Ensure Your Products Work in the Smart Grid.

Environmental Label Green Product Mark

Clearly label sustainable products with TÜV Rheinland’s Green Product Mark.

Specific Absorption Rate (SAR) Testing

Specific Absorption Rate (SAR) testing ensures the safety of wireless devices for human use.

ISO 14001

Get your environmental management system certified according to ISO 14001.

IEC 60601-1 Medical Electrical Equipment

IEC 60601 Series – Medical Electrical Equipment

Test medical electrical equipment for compliance with IEC 60601-1 standard and beyond.

In Vitro Diagnostic Medical Device Regulation (IVDR)

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

RoHS

We test electrical and electronic devices according to the international standards applicable to your products.

Electromagnetic Compatibility (EMC) Testing

From medical products to wireless devices and beyond, our EMC testing services keep you compliant.

Wi-Fi Testing and Certification

We provide Wi-Fi testing and certification for wireless products sold around the world.

Zigbee Testing and Certification

We test and certify products for automated smart systems supported by Zigbee technology.

RED Directive: Telecommunication Products

Telecommunication Products - Compliance with RED Directive

Conformity Evaluation for Radio Installations and Telecommunications Products.

REACH

Registration, evaluation, authorization and restriction of chemicals.

Medical Products (MDD)

TÜV Rheinland offers a wide range of testing and certification services for Medical Devices

Bluetooth® Qualification Services

We provide qualification services for Bluetooth® compatible devices to ensure quality products operate safely and reliably.

Sigfox Testing and Certification Services

We conduct testing and Sigfox Ready™ certification of devices for use on the Sigfox network.

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.

Non-Active Medical Device Testing

Increase your competitive edge and certify your non-active medical device products.

cTUVus Certification from an Accredited NRTL

A step ahead of the rest – with cTUVus certification for the North American market.

Usability and Ergonomics

A Real Plus for Your Customers: Functionality and Ergonomics.

Medical Device Single Audit Program (MDSAP)

A reduction in audits means less business disruption.

NRTL – Certification for North America and more

With us as an experienced testing service provider and NRTL, you can bring your product to the North American market.

International Approval for Medical Devices

Your Gateway to New Markets.

Active and Non-Active Medical Devices

Active and Non-Active Medical Devices.

Energy Efficiency and Saving Energy

Improved Climate Protection with Energy-Saving Products.

Over the Air (OTA) Testing

OTA (Over the Air) testing ensures wireless device performance and overall device system performance.

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