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Certification and Auditing Services for Active Medical Devices


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.

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.

CB Procedure
CB Scheme 

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

cTUVus Certification
cTUVus Certification from an Accredited NRTL 

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

EN ISO 13485 Certification
Certification According to EN ISO 13485 

Validating Your Quality Management System.

Green Product Mark
Green Product Mark 

One, single label indicating the overall environmental preferability of your product - direct, quick and efficient.

ISO 14001 Certification
ISO 14001 Certification for the Environmental Management System 

Have your environmental management system certified by TÜV Rheinland in accordance with ISO 14001.

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

Contact

Get in contact with us!

Get in contact with us!