Labelling Requirements

Labelling Requirements

Economic OperatorSwissEUUK
AR/RPCH REP on the product label.NameAddress of registered place of business.Deadline: MDD: 26/05/2021 MDR: 26/05/2021 (if applicable depending on transition period)      OMC Swiss AR Address: OMCS Medical Gmbh C/O Mr Wilhelm Gudelow Aegeristrasse 5 6300 Zug  EU AR on the product labelNameAddress of registered place of business.Deadline: 26/05/2025           OMC EU AR Address: OMC Medical Spolka, Z Organiczona, Pegaz, 3rd Floor, Building B, Grabarska 1st str. Wroclaw, 50-079  UK Responsible person on product label for UKCA marked devices only.NameAddress of registered place of businessDeadline 30/06/2023   No specific symbol required   OMC UK RP Address: OMC Medical Limited, Planet House, North heath lane, Horsham RH12 5QE.  
ImporterCH Importer on the product, product packaging or a document enclosed with the product. NamePlace of businessContact address Deadlines: MDD: 31/07/2022 MDR: 26/05/2021   Note: Swissmedic requires the CH importer to be stated from 31.07.2022 if: EU interpretation has not been published by then.Swissmedic recommendation implementation from 26.05.2021Importer on device or on its packaging or in a document accompanying the device.NameRegistered trade name or registered trademark.Registered place of business andContact address.Deadline: 26/05/2025No Labelling requirement at this stage.
Compliance symbol OMC Medical - omcmedical.comDual labelling is allowed in UK so you can have both CE and UKCA marking on your products.

CHRP Symbol – Please follow the link to download the CHRP symbol( available formats ai., Jpeg,png,eps)

EURP Symbol – According to ISO 15223.

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