MDR (EU) 2017/745

The declaration of conformity also serves as a clearance certificate, as the MDR requires proof of biocompatibility for all materials that come into direct or indirect contact with patients or users.

MDR, Appendix I, Paragraph10.2:

Devices shall be designed, manufactured and packaged in such a way as to minimize the risks posed by contaminants and residues to patients - taking into account the intended purpose of the device - and to transport, storage and operating personnel. Special attention is paid to tissues exposed to these contaminants and residues, as well as to the duration and frequency of exposure.

• DIN EN 13485 Medical devices- Quality management systems - requirements for regulatory purposes
  
• DIN EN 9001 Quality management systems - requirements
  
• DIN EN 14001 Environmental management systems - requirements
  
  

ISO 13485 Zertifikat

ISO 9001 Zertifikat

ISO 14001 Zertifikat

KayserBetten beds provided before 26.05.2021 can be used again without restriction after professional "reprocessing" by cleaning, disinfection, as well as testing and restoration of the technical and functional safety.

Background:

The so-called "sell-off provision" (Art. 120(4) MDR) is intended to limit the period during which MDD-compliant products that were already placed on the market (for the first time) before 26.05.2021 may be made available, e.g. by a distributor.

After 27 May 2025, these products may no longer be made available/put into service. Such products that are still in the commercial chain on that day - i.e. have not yet been made available to the end user (e.g. institution, family) as a ready-to-use product - are no longer "tradable".

Trade in used products is not covered by the so-called "sell-off" rule (see MDR recital 3 *). This means that once a product has been made available to the end user (e.g. institution, family) as a ready-to-use product, the further making available of this product on the market does not fall under the scope of the MDR.

* MDR, Legal Notice, Recital 3: "This Regulation is not intended to harmonise rules concerning the continued making available on the market of medical devices that have already been put into service, for example in connection with the sale of used devices."
Source: Federal Ministry of Health NACI - National Working Group for the Implementation of the EU Regulations on Medical Devices (MDR) and In Vitro Diagnostic Medical Devices (IVDR EU Regulation on In Vitro Diagnostic Medical Devices).

Definitions:

Placing on the market
"the making available on the Union market of a product, other than a device for testing, for the first time;".

Making available on the market
"any supply of a product, other than investigational devices, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge".

Source: MDR

The Medical Devices Regulation (MDR) and other regulatory requirements stipulate that the expected service life of medical devices must be specified for safe use and conformity assessment (see Annex I, GSPR 23 MDR).

The specified service life defines the period for which a manufacturer guarantees the safe and effective use of its medical device when used as intended.

For KayserBetten care beds, the expected service life when used as intended is 5 to 10 years, depending on use and maintenance.

The service life is also influenced by two components, the wooden frame and the insert frame. In the event of a partial replacement, the older of these two components is decisive for the service life of the bed.

The service life may also be reduced by the conditions and frequency of use, as children's nursing beds are sometimes subjected to intensive and unpredictable stress – both mechanically and hygienically.

The performance/safety and thus the continuation of the service life of up to 10 years must be ensured by annual maintenance/safety inspection (STK).

Once the service life has expired, KayserBetten can no longer guarantee performance and safety. A bed that is needed beyond its service life must therefore either be replaced in good time or responsibility for its operation, performance and safety is transferred to the operator (usually the health insurance companies).

Furthermore, KayserBetten is not obliged to supply spare parts for such beds.

FAQ

What is the service life of a medical device and what is its purpose?
The specified service life defines the period during which we, as the manufacturer, guarantee the safe and effective use of our medical device when used as intended.

Is it necessary to specify a service life?
The Medical Devices Regulation (MDR) and other regulatory requirements stipulate that the expected service life of medical devices must be specified for safe use and conformity assessment (see Annex I, GSPR 23 MDR).

How many years is the service life of Kayser beds?
For KayserBetten nursing beds, the expected service life when used as intended is 5 to 10 years, depending on usage and maintenance. The service life is also influenced by two components, the wooden frame and the insert frame. If parts have already been replaced, the older of these two components is decisive for the service life of the bed.

What is the specific basis for the 5-10 year time span?
The performance/safety and thus the continuation of the service life up to 10 years must be ensured by annual maintenance/safety inspection (STK).

Can the service life be less than 5 years?
Yes, the service life can be reduced by the conditions and frequency of use, as paediatric beds are sometimes subjected to intensive and unpredictable stress – both mechanically and hygienically.

What happens when the service life expires?
Once the service life has expired, KayserBetten can no longer guarantee performance and safety. A bed that is needed beyond its service life must therefore either be replaced in good time (as a rule) or responsibility for performance and safety is transferred from KayserBetten to the operator (usually the responsible health insurance company). In addition, the entitlement to spare parts deliveries by KayserBetten for such beds no longer applies.

We guarantee the supply of spare parts for the expected service life.

This availability is limited to parts which, according to experience, are subject to wear within the normal service life of KayserBeds. The guarantee of availability does not apply to other parts which exceed the service life of the beds from KayserBetten.

Technical changes also limit the availability period of spare parts, as our products are continuously developed to ensure that they always comply with the current state of the art and legal requirements when they are placed on the market. This results from our quality management and is a common procedure in the manufacture of medical products.

According to the MPBetreibV §7, operators of care beds are obliged to ensure the safe condition of the medical device over the entire period of use.

To ensure safe operation, a visual and functional inspection with electrical testing must be carried out at least once a year in accordance with DIN EN 62353.

The test according to DIN EN 62353 includes the following minimum requirement:

• Visual inspection
• Insulation resistance measurement
• Leakage current measurement
• Functional test
• Overall evaluation

You can download the KayserBetten maintenance protocol below:

Wartungsprotokoll

Meldeformular Art.88 - Rev.1.0 >> For more info, see Monitoring products on the market

In accordance with MDR Article 10 Paragraph 11, all our products are supplied with an up-to-date operating manual.

If you require additional operating instructions (printed or as a PDF file), please call us or send us an e-mail. For a quick processing we need the corresponding serial number. You will find it on the product label.