The new EU Medical Device Regulation (MDR) comes into force on 26 May 2021 - one year later than planned due to the coronavirus pandemic. The Stiegelmeyer-Group has already completed implementation of the MDR. 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.
Further exclusive information on this topic can also be found in FORUM, the Stiegelmeyer-Group’s customer magazine.
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.
No, our models comply with all the statutory requirements right from the start, and these requirements have not been changed by the MDR. The only change is the "MD" label on the type plate - for "Medical Device” (Medizinprodukt). Internally, we have supplemented our documentation for the beds. Internal processes, for example for market observation, traceability and risk assessments, now precisely meet the new, more stringent requirements of the MDR.
You can find an overview of the new requirements of the MDR in our FORUM customer magazine:
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.