relabelling

Article 16 – some loose ends in the Regulations…

by

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?

by

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

© 2023 | Boumans Regulatory Consulting BV

2022-Logo-Jannie-de-Groot.jpg

Jannie de Groot Grafische vormgeving

Application form

Company data
PRRC data
PRRC role
PRRC specific topics
Optional mailing list
Do you want your name and email address to be share with the other participants in the training? If you agree you will be added to a group mailing list, if you don’t agree or you don’t indicate anything, you will receive the same messages individually.
Optional coaching
For PRRCs that want additional personal training, there is the option of booking this together with your training. For most PRRCs 2-5 hours will be adequate.
Thank you for your application.

You will soon receive a confirmation in your mail. If not, check your spam or mail me.

Share this!