Medical Device Regulation (MDR)
Medical Device Regulation (MDR)

Important information on the new EU Medical Device Regulation

The new EU Medical Device Regulation (MDR) became binding on May 26, 2021. The Stiegelmeyer Group had already completed the implementation of the MDR before this date. This means planning security for our partners who buy or sell our beds in purchasing associations and medical supply stores.

All newly delivered beds from Stiegelmeyer and Burmeier have been MDR-compliant since May 2020. Existing beds purchased before this can continue to be used indefinitely. After all, the MDR does not change the design of the beds. The only difference you will see is the new "MD" label (Medical Device - Medizinprodukt) on the type plate.

If you would like to look at the new EU declaration of conformity and the declaration of compliance with the MDR directive, you can request these documents from our customer centre. Simply write an email to service(at)stiegelmeyer.com.

The MDR requires retailers to document any error messages in connection with medical devices in a register and to pass this information on to manufacturers. We would like to support you with this obligation to submit feedback: Once a year, we will contact you and ask for specific suggestions for improvement. We will then use this market observation to ensure, together with you, that our beds are continually improved.

For all other matters concerning the MDR, your usual contacts in our field service and in-house sales department will be pleased to assist you.

Benefit from the expertise of the Stiegelmeyer Group

Strict implementation of national and international standards has been a core competence of the Stiegelmeyer Group for many decades already. In many cases, our safety officer has advised on the drafting of standards.  You can therefore rely on our PRRC (Person Responsible for Regulatory Compliance) to continue to implement all MDR-related processes circumspectly in future. Please use the contact form if you have any questions about this subject.