EU Authorised Representative Pitfalls

Food for Thought / MDR (EU-2017/745) How To's / QA/RA News

The MDR has implemented quite some surprises for medical device manufacturers who are not established in the EU. They need an authorised (authorized in American English) representative who is established within the EU. That’s clear for most manufacturers as they already have importers and they are somehow authorised. But the …

MDR in sudden force: Brexit decision about to export for British MD companies.

QA/RA News

EU Withdrawal Bill clears House of Commons – and is about to nuke MD companies (Photo by frankieleon https://www.flickr.com/photos/armydre2008. Licensed under Creative Commons License https://creativecommons.org/licenses/by/2.0/legalcode.)   On January, 17th 2018 the British House of Commons agreed to a law that is putting a dramatic threat to the British medical devices …