Medical Devices

New Medical Device Regulation

What does it mean for manufacturers?
On 5th April 2017 the European Parliament voted to adopt the long awaited Medical Device Regulation (MDR) and In vitro Diagnostic Regulation (IVDR)

Unannounced Audits

The European Commission Recommendation 2013/473/EU on audits and assessments performed by notified bodies in the field of medical devices was published on September 24th 2013.The purpose of the Recommendation is to enhance patient safety especially following the Poly Implant Proth

RESPONSE TO NEWS PUBLISHED BY THE DANISH MEDICOINDUSTRIEN

Please be aware that a ”breaking news” has been released from “Medicoindustrien” (a national association within MedTech Europe) informing that Presafe Denmark A/S will close, that all certification activities will be moved to Presafe headquarter in Norway and that this will lead to a change of th

Pages