The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
European medical devicemakers will be required to use a new labeling standard that reduces the need for multiple languages on a single label and reduces potential confusion and delays for selecting the appropriate language when using a device. “Countries require their local languages to be used to display information associated with medical devices and this can cause problems relating to translation, design and labeling of products and documentation,” said Andy Vaughan, committee member of the British Standards Institution (BSI), which published the new standard. International Medical Device Regulatory Monitor