Registrations
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.
Requirements of Technical Documentation EU MDR
The technical documentation shall be presented in a clear, organised, readily searchable and unambiguous manner. It shall include all the elements listed in Annex II of EU MDR.
“Professional use” Test Kit – Procedure for registration in UK
"Professional use" Test Kit - Procedure for registration in UK Novel Corona Virus Disease 2019 (COVID-19) is a different variety of disease that has never been seen in humans before, impacting being a pandemic, and affecting the world since the year 2020. One of...
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...
Labelling Requirements – Swiss Authorized Representative
Label Written, printed, or graphic information appears either on the device itself or on the packaging of each unit or the packaging of multiple devices (Art. 2 point 13 MDR). Timeline for Information on Indication of CH-REP “on the device” or “in the accompanying...
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...