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Active Medical Devices


TÜV Rheinland

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.

Unannounced audits

Commission Recommendation of 24th September 2013 on the audits and assessments performed by notified bodies in the field of medical devices (2013/473/EU) was published on 24 September 2014 and entered into legal force on 25 September 2013 by publication in the Official Journal of the European Communities.

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New Regulations for Medical Products

pdf New IVDR 1 MB Download
pdf New MDR 1 MB Download
pdf Information according to the new European Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR) 290 KB Download

Our portfolio

Active und Non-Active Medical Devices
Active and Non-Active Medical Devices 

Active and Non-Active Medical Devices.

Approvals for Greater China
Approvals for Greater China 

Let us help you with product approvals for China, Taiwan, and Hong Kong.

Bluetooth® Testing
Bluetooth® Testing 

Ensure qualification and listing of your Bluetooth® products.

CB Procedure
CB Scheme 

Safety testing and CB certification for electrical and electronic components and products.

EEBus
EEBus 

The new data communication standard connects the smart home and the smart grid.

EN ISO 13485 Certification
Certification According to EN ISO 13485 

Validating Your Quality Management System.

Energy Efficiency and Saving Energy
Energy Efficiency and Saving Energy 

Improved Climate Protection with Energy-Saving Products.

FCC / TCB Approvals
FCC / TCB Approvals 

Secure FCC Approval for Your Products with TÜV Rheinland.

G3-PLC
G3-PLC 

Certification of the correct implementation of G3-PLC specifications.

IP500
IP500 

Certification for interoperable IP500 communication modules and products.

KNX
KNX 

Certification testing services for KNX devices and systems.

LoRa Alliance Certification
LoRa Alliance Certified Program 

We test and certify your LoRaWAN devices according to the requirements and specifications of the LoRa Alliance.

Medical Device (tested)
Tested Medical Device 

Market Your Products More Effectively with Voluntary Certification.

Medical Products (MDD)
Medical Products (MDD)  

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

NFC Certification
NFC Certification 

Testing your NFC-enabled devices to guarantee the best performance.

OpenADR
OpenADR 

Correct functionality and performance of OpenADR products.

RED Directive: Telecommunication Products
Telecommunication Products - Compliance with RED Directive  

Conformity Evaluation for Radio Installations and Telecommunications Products.

Smart Grid Product Testing
Smart Grid Product Testing  

Ensure Your Products Work in the Smart Grid.

Wi-SUN
Wi-SUN 

Certification testing for Wi-SUN applications.

Wireless Testing
Wireless Testing 

Make Wireless Global Testing and Certification Easy with TÜV Rheinland.

ZigBee® Certification
ZigBee® Certification 

Testing and certification services for your product’s future success.

Contact

Get in contact with us!

Get in contact with us!