Registrations

MDCG Guidance for Manufacturers of Class I Medical Devices

MDCG Guidance for Manufacturers of Class I Medical Devices

This document is intended to serve as guidance for Class I medical device manufacturers (excluding custom-made devices) that sell products bearing their name or trademark on the Union market in order to comply with MDR requirements. This guidance should also apply when an importer, distributor, or any other legal entity takes on the obligations owed by manufacturers.

Labelling Requirements

Labelling Requirements

Economic OperatorSwissEUUKAR/RPCH REP on the product label. Name Address of the 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...

MEDICAL DEVICE REGISTRATION IN ROMANIA

MEDICAL DEVICE REGISTRATION IN ROMANIA

How OMC Medical can assist you with the process Act as your Romanian AR Help you with the Romanian registration by filling in the form and registering the medical device with the NAMMD authorities. Translate your documents to Romanian for...