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Certification and Auditing Services for Non-Active Medical Devices


TÜV Rheinland

In a medical setting, it is not only the high-tech equipment that makes a difference to positive outcomes. Non-active medical devices also have a crucial role to play and are held to equally high standards when it comes to safety and compliance. As a manufacturer of non-active medical equipment, you strive to fulfill the expectations of health care professionals as well as the authorities in charge of regulating your products. Our services can help you meet these expectations. With experts in the field active around the globe, we enable you to demonstrate the safety and reliability of the devices you manufacture, and at the same time to inspire confidence in your customers.

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 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 

We provide comprehensive approval and certification services for fast entry to Greater China market.

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.

EU Medical Device Regulation MDR 2017/745
EU Medical Device Regulation MDR 2017/745 

Supporting access to European markets for medical devices under MDR 2017/745.

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 

We certify your environmental management systems according to ISO 14001.

ISO 15378 Certification
Certification According to ISO 15378 

Marketing Well-Packaged Pharmaceuticals.

Medical Device (tested)
Tested Medical Device 

Market Your Products More Effectively with Voluntary Certification.

Medical Device Processing
Medical Device Processing 

Medical Device Processing (including "C Critical" Devices).

Medical Device Single Audit Program (MDSAP)
Medical Device Single Audit Program (MDSAP) 

We conduct MDSAP audit and certification services to enable market access.

Medical Products (MDD)
Medical Products (MDD)  

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

PN-EN 14065 – Certification in the Laundry Service Industry
PN-EN 14065 – Certification in the Laundry Service Industry 

Certification in the laundry service industry according to PN-EN 14065 standard.

Contact

Get in contact with us!

Get in contact with us!