Why is the new EU IVD Regulation creating a storm?

Why is the new EU IVD Regulation creating a storm?

Just last week, we have discussed on the publication of the new European Medical Device Regulations (MDR), 2017/745. The Regulations has come into force on 25th May 2017, marking the start of the transition period for companies selling medical devices into Europe.  Similarly, the in-vitro diagnostic devices (IVD) has gone from a Directive to an enforced Regulation – 2017/746.

The new EU Medical Device & in-vitro Diagnostic Regulations - How does it impact your organisation?

The new EU Medical Device & in-vitro Diagnostic Regulations - How does it impact your organisation?

Stendard, together with TÜV Rheinland andMT Promedt Consulting GmbH, is organising the first-ever tripartite workshop! Come and get first-hand updates on the new Medical Device Regulation (MDR) and in-vitro Diagnostic Regulation (IVDR), what are Notified Bodies look out for during the audits and how you can utilise eQMS software to better manage your QMS during this transition period.