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FAQ

Frequently Asked Questions

TROGE MEDICAL GMBH is a manufacturer and distributor of pharmaceutical products and medical devices with over 35 years of experience.

TROGE MEDICAL GMBH is a manufacturer and distributor of pharmaceutical products and medical devices with over 35 years of experience.

Our production facilities are located in Europe and Asia.

You can meet us at various trade fairs around the world, including: MEDICA, Düsseldorf – Germany ARAB HEALTH, Dubai – UAE FIME Miami – USA HOSPITALAR – Sao Paolo, Brasil. More information about these trade fairs can be found in the NEWS section of our website. Or come and visit us in the beautiful northern city of Hamburg, Germany, where we are based, with the third largest container port in Europe! We look forward to meeting you!

Products can be ordered through our extensive global network of authorized distributors. Please contact us, we will be happy to assist you in finding your local distributor.

We work with carefully selected authorized distribution partners in over 70 countries covering over 110 countries world-wide.

Your company/institution should be authorized by your local health authority to trade in pharmaceuticals and/or medical devices in your country. Furthermore, we require our distribution partners to have adequate storage facilities as well as documented procedures or a quality assurance system already in place and preferably to be ISO 9001 certified.

We value distribution partners that support us in Post Market Surveillance activities, which is a key issue of the new MDR, and to help us to continually improve our service.

All our production facilities have been approved for GMP or MDD/MDR compliance in line with respective regulations and are inspected regularly by recognized international and/or local inspection authorities according to the relevant regulations.

All our products comply with international standards such as EP, BP, USP monographs (pharmaceutical products) and DIN, EN and ISO norms (medical devices). Furthermore, all our medical devices are CE certified.

While the Medical Device Regulation (MDR) 2017/745 has become valid after the transition period ended on 26 May 2021, the Medical Device Directive 93/42 (MDD) has finally been replaced by the MDR.

What does this mean for TROGE MEDICAL products?

Taking advantage of the final transition deadline for existing MDD certifications, we are working at full speed to implement all the necessary requirements to apply for CE certification according to MDR.

After formal application for MDR certification at our Notified Body, our current CE certification under MDD will be valid even until the end of 2028. On 20 March 2023, the European Union once again extended the EU MDR transition periods for devices transitioning to the EU MDR. The good news for our distribution partners the EU sell-off date has been fully removed. That means that medical devices you buy from us may continue to be made available on the EU market or put into service without any limitation in time without prejudice to the device’s possible shelf-life or expiry date.

Currently, it is not known how long our Notified Body will need after the application for product certification according to MDR. Once submitted the certification process will be completely in our Notified Body’s hand and beyond our control. Please rest assured, that our expert Regulatory Affairs team will do their utmost to complete the process within the given deadlines.

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