Medical Device Regulation

IMPORTANT INFORMATION ON THE NEW EU MEDICAL DEVICE REGULATION

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@stiegelmeyer.com.

further Information in Stiegelmeyer Group Blog

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.

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Questions and answers about the Medical Device Regulation

You can order beds before 26 May 2021 without concern. Our beds are already MDR-compliant.

No, since these beds are previously classified as a class 1 medical product, they can continue to be used indefinitely, as they do not require new approval of MDR-compliance by an external body. This also applies even if beds are stored between use.

No, since Burmeier as the manufacturer officially placed these beds on the market before the MDR came into force, you can use the beds indefinitely without any restriction.

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.

For Burmeier, we already made these documents available in May 2020 in the retailer section of our website: www.partner.burmeier.com. For beds from Stiegelmeyer, you can request the documents from our customer centre: by e-mail to service@stiegelmeyer.com or by phone to +49 (0) 5221 185 – 777.

You can find an overview of the new requirements of the MDR in our FORUM customer magazine:
https://www.stiegelmeyer-group.com/en/blog/article/despite-postponement-stiegelmeyer-and-burmeier-are-ready-for-the-mdr/

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