Notification
With the start of the MDR (EU) 745/2017 on 26 May 2021, new regulatory requirements come into force in the EU.
Currently the new documents are uploaded and will be available for download soon.
All LEVO models are compliant with MDR and remain available within the usual delivery times even after the start of the MDR!
Updates for LEVO partners regarding the MDR:
- EU declaration of conformity and UDI
- EU Authorised Representative
EU Declaration of Conformity and UDI
The EU Declaration of Conformity according MDR (EU) 745/2017 are shown in the user instructions.
Our wheelchair products are class I medical devices.
Basic UDI-DI (GMN)
07613045 31 => LAE
07613045 41 => LCEV Kid
07613045 51 => LCEV Junior
07613045 71 => LCEV
07613045 73 => Summit EL
07613045 91 => C3
07613045 92 => Combi
07613045 95 => Combi Junior
The UDIs will be registered in the EUDAMED as from 26 May 2021.
The transition period for placing UDI-carriers on the label of Class I products is May 26, 2025.
European Authorised Representative
Until the mutual recognition agreement (MRA) between Switzerland and the EU comes into effect, we as a Swiss manufacturer of medical devices are dependent on an European authorised representative (EAR).
The authorised representative takes over the legal representation of the manufacturer in the EU. Reports about serious incidents are sent to us (manufacturer) as well as to our EAR.
European Authorised Representative:
be-on-market GmbH
Lilienstrasse 33
91244 Reichenschwand
GERMANY
Important: The handling of all technical and commercial issues remains as before through LEVO AG, Switzerland and its distributors.
SRN: follows after release in the EUDAMED
