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Testing and Assessment Services for 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.

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

Acoustics Testing and Measurement
Acoustics Testing and Measurement 

Audiological Testing and Vibration Measurement.

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.

REACH
REACH 

Registration, evaluation, authorization and restriction of chemicals.

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!