current language
USA available in the following languages:
or select your TÜV Rheinland country website:

Services for Active Implantable Medical Devices


TÜV Rheinland

Current medical technology is capable of delivering healing solutions via active implantable medical devices (AIMD). These products work inside the patient’s body to calibrate and regulate physical functions, improve quality of life and extend life spans. Because they are designed to essentially become part of an individual’s body, AIMDs are subject to special scrutiny regarding safety, functionality and durability. As a manufacturer of implantable medical devices, it is your priority to stand up to this scrutiny and even exceed expectations when possible. With experts by your side with specialized knowledge of this technologically sophisticated field, your chances for success rise substantially. Our services for AIMDs address your goals and concerns, enabling you to consistently demonstrate compliance and build a strong record for safety and reliability in your sector

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.

Read more

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 Implantable Medical Devices (AIMD)
Active Implantable Medical Devices (AIMD)  

Conformity Assessments for Your Active Implants.

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

Active and Non-Active Medical Devices.

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.

Information Technology Products
Information Techno­logy Products 

A Testing Bay for IT Products.

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.

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!