With the cut-off date of 26.05.2021, the Medical Device Directive 93/42/EEC will be replaced by the new, Europe-wide Medical Device Regulation (EU) 2017/745 ( MDR - Medical Device Regulation ). This means significant changes for us as a manufacturer and for you as a specialist dealer in the area of production and trade of medical devices.
W.Söhngen GmbH has been certified for the production of sterile medical devices since 1996 and is audited in regular audits by an independent conformity assessment body. In cooperation with this Notified Body, our medical devices are converted to the requirements of the new Medical Device Regulation.
In our brochure (Download) we inform you - as our sales partner - about the facts and news relevant for you, which result from the new Medical Device Regulation.
The information refers exclusively to medical devices of the company W.Söhngen GmbH of the classes I and Is.
1.) Can products produced according to provisions of the old MDD 93/42/EEC still be used?
Yes, if stored properly, if the packaging is undmaged and within the expiration date.
2.) Can products that were produced according to the provisions of the old MDD 93/42/EEC continue to be sold?
The sales regulation according to Article 120 MDR is: products lawfully placed on the market before 26.05.2021 according to the old law (MDD), as well as products placed on the market after 26.05.2021 with a still valid MDD certificate, can continue to be provided on the market or put into service until 27.05.2025.
3.) What are the storage and transport conditions specified by SÖHNGEN® as 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).
4.) How are medical devices packed for transport?
SÖHNGEN® uses suitable primary, secondary and tertiary packaging for the medical devices.
5.) How do we obtain a Declaration of Conformity?
Upon request from the manufacturer, if it is a medical device.
6.) Will SÖHNGEN® sterile dressing materials continue to carry a 20-year shelf life?
7.) Does the specialized trade have to actively inform its customers about changes in the course of the new MDR?
No, because the MDR does not specify that distributors must inform their customers.
We will be happy to answer any further questions you may have.
First Aid • Emergency Medicine
Platter Straße 84
Tel.: 06128 873-0