Medical devices and procurement
Frequently asked questions
Regulatory background and the questions most often asked in procurement.
Medical device regulation
A medical device is an article or substance that the manufacturer has assigned a medical purpose, for example diagnosis, monitoring, treatment or alleviation. The definition is set out in Article 2 (1) of Regulation (EU) 2017/745 (MDR). Unlike a medicinal product, a medical device achieves its principal action by physical means, not pharmacological, metabolic or immunological ones.
The intended purpose is the use for which a manufacturer has designated a device, as stated in the labeling, the instructions for use and the sales material (MDR, Article 2 (12)). It determines whether a product is a medical device at all, and it then governs classification, risk management and clinical evaluation. For the Rescue Trade™ product lines it is: use on patients in healthcare facilities, for short-term single use.
The MDR classifies medical devices by risk into classes I, Is, Im, Ir, IIa, IIb and III (Article 51 and Annex VIII). The class determines which conformity assessment procedure applies. The Rescue Bedding™, Rescue Transfer™ and Rescue Carry™ product lines are assigned to class I.
Without CE marking, a medical device may not be placed on the market in the EU. It may only be affixed once the device meets the general safety and performance requirements of Annex I of the MDR and has completed the prescribed conformity assessment procedure (Article 20 and Annex V). For class I devices without a special case, no notified body is involved; the manufacturer declares conformity under its own responsibility.
In the EU declaration of conformity, the manufacturer declares that a device meets the requirements of the MDR and assumes responsibility for doing so (Article 19 and Annex IV). It states, among other things, the Basic UDI-DI, the risk class and the conformity assessment procedure applied. The declarations for all three product lines are available for download on the respective product pages.
Because Rescue Trade™ has designated them for use on patients in healthcare facilities, which means they meet the definition in Article 2 of the MDR. What a product does is stated in the intended purpose of its declaration of conformity: the disposable bedding set provides a physical barrier against the direct transmission of potentially infectious germs to the patient. The disposable transfer sheet minimizes friction and shear when transferring a patient. The disposable transport sheet assists emergency and healthcare personnel in transporting immobilized patients from areas that are difficult to access with conventional stretchers.
Procurement and delivery
Rescue Trade™ operates under a quality management system certified to DIN EN ISO 13485 by DQS Med. The Rescue Bedding™, Rescue Transfer™ and Rescue Carry™ product lines are Class I medical devices in accordance with MDR (EU) 2017/745.
We deliver by the carton from stock. Talk to us about volume pricing and framework agreements, and we will prepare a quote at short notice.
Depending on the product line, soft, tear-resistant nonwovens are used. All units are sealed individually in a poly bag and intended for single use.
Orders are processed immediately and are available from stock at our Ortenberg warehouse. More than 3 million units of our own products are held in stock; we operate warehouses in Europe and the United States.
Yes. For hospitals, emergency medical services, care facilities, public authorities and civil protection we set up emergency call-off quantities with reserved stock.
Bedding sets are available in various thermal ratings and configurations. Talk to us about requirements specific to your organization.