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Testing and Assessment 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

Application for designation under the Medical Device Regulation (MDR) 2017/745

Medical Device Regulation (MDR) 2017/745

Notified Bodies are allowed to apply first-time since November 26, 2017 for designation under the Medical Device Regulation (MDR) 2017/745. We are glad to inform you, that our application is already filed and covers a comparable scope as currently maintained by us.

Unannounced audits

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.

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.

EN ISO 13485 Certification
Certification According to EN ISO 13485 

Validating Your Quality Management System.

Over the Air (OTA) Testing
Over the Air (OTA) Testing  

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

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

Conformity Evaluation for Radio Installations and Telecommunications Products.

RoHS Compliance Testing
RoHS Compliance Testing 

The Electrical and Electronic Equipment Act.

Sigfox Testing and Certification Services
Sigfox Testing and Certification Services 

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

Specific Absorption Rate (SAR) Testing
Specific Absorption Rate (SAR) Testing 

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

Contact

Get in contact with us!

Get in contact with us!