relabelling – Boumans Regulatory Consulting

Article 16 – some loose ends in the Regulations…

2022, August 152022, August 14 by Ronald Boumans

Article 16 inconsistencies As you can read in another tip of the week, MDR Article 16 allows for a third party to repackage or relabel a device or to translate the instructions for use and add them to a device already placed on the market. Packaging, labelling and providing user information are typical manufacturer’s responsibilities … Read more

Article 16, where ends the responsibility of the manufacturer?

2022, August 82022, August 6 by Ronald Boumans

Manufacturer versus importer/distributor The MDR relates specific roles and responsibilities to manufacturers, importers and distributors. Only the manufacturer should therefore make changes to the information provided with the device and the packaging. However, sometimes the importer and/or the distributor make such changes. Article 16 of the MDR/IVDR sets out when such change puts a manufacturer … Read more