L&R standard devices
What changes will this mean for L&R standard devices in the OR?
How will this affect the availability of L&R devices?
Once the technical documentation has been revised, these devices will continue to be available for use in the OR and on wards
- Raucodrape OR Drape Sheets
- Sentinex OR Clothing
- Sentina Examination Gloves
- Setpack OR Dressing Materials
- Sentina Single-use Instruments
- Sentina Hygiene Products
- Kitpack OR Custom Procedure Trays
- Due to the deletion of components by our suppliers, the composition of the sets may change.
What changes will this mean for the L&R OR Custom Procedure Trays?
The L&R OR Custom Procedure Tray is subject to Article 22 MDR (currently, Article 12 MDD)
- Individual CE-certified components are generally used for the OR Custom Procedure Trays. Devices subject to Article 22 MDR will not themselves have an additional CE mark.
Once sterile devices are removed from their packaging, the original conformity of these devices is no longer given. For this reason, sterile devices can no longer be removed from their packaging for use in the OR Custom Procedure Trays.
- These will be supplied in the OR Custom Procedure Tray either in their sterile packaging or, if vailable, as a non-sterile bulk pack.
Technical documentation L&R devices
- The technical documentation for all L&R devices for L&R individual sets needs updating.
Loss of components
- Due to the possible deletion of components, the composition of the sets may change.
- Should there be any changes to the components in your sets, your L&R contact person will contact you immediately.