Medical Device Regulation
Explore the most important information on the Medical Devices Regulation - (EU) 2017/745
MEDICAL DEVICE REGULATION (EU) 2017/745
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As of 26.05.2021, the Medical Device Directive 93/42/EEC has been replaced by the new, Europe-wide Medical Device Regulation (EU) 2017/745 (MDR). This means considerable changes for us as a manufacturer and for you as a specialist dealer in the area of production and trade of medical devices. In cooperation with this Notified Body, our medical devices are being converted to meet the requirements of the new Medical Devices Ordinance. SÖHNGEN has been certified for the production of sterile medical devices since 1996 and is regularly audited by an independent conformity assessment body. In cooperation with this notified body, our medical devices have been converted to the requirements of the new Medical Devices Ordinance.
FAQ on the topic of MDR
Can products manufactured according to the provisions of the old MDD 93/42/EEC continue to be used?
Yes, if stored properly, undamaged packaging and within the expiry date.
Can products manufactured according to the provisions of the old MDD 93/42/EEC continue to be sold?
The phase-out provision under Article 120 MDR is as follows: products lawfully placed on the market under the old law (MDD) before 26.05.2021, as well as products placed on the market after 26.05.2021 with an MDD certificate that remains valid, may continue to be made available on the market or put into service until 27.05.2025.
What are the storage and transport conditions specified by SÖHNGEN® as the manufacturer?
Storage and transport conditions: dust-free, dry (protect from moisture), protect from sunlight, protect from damage, protect from pest infestation (use suitable secondary and tertiary packaging for transport).
How are medical devices packaged for transport?
SÖHNGEN® uses suitable primary, secondary and tertiary packaging for the medical products.
How do we obtain a declaration of conformity?
On request from the manufacturer, if it is a medical device.
Will SÖHNGEN® sterile dressing materials continue to carry a 20-year shelf life?
Does the retail dealer have to actively inform its customers about changes in the course of the new MDR?
No, because the MDR does not state that the retail dealer has to inform his customers.