The European Commission’s Medical Device Coordination Group (MDCG) has updated Medical Device Regulation (MDR) guidance aimed at manufacturers and notified bodies that work with implantable and Class III devices.
The main purpose of this document is to provide guidance on the presentation, content and validation of the SSCP. The link to the article can be found here.
Please contact Michael O’Brien at michael.obrien@aqf.ie to arrange a meeting to discuss your medical foam requirements.
