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.
As you might have heard, the EU Medical Devices Regulation (MDR) has been enforced recently, possibly impacting every medical device that are already selling in Europe or intending to be sold in Europe. Out of the entire list of new implementations within the EU MDR, we have handpicked 6 of them that are likely to affect most of you.
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.
Earlier this month, the Regulatory Compliance Clinic was conducted over the course of two days, allowing us to meet up with 20 teams and to hear all your concerns about the regulation requirements. All thanks for Dr Michael Rinck (MT Promedt Consulting GmbH) and Mr Jason Lim (Stendard), the event was a huge success!
All startups face similar set of challenges in the early days – fund raising, managing project timeline, establishing relationships with suppliers, engaging potential customers and the list goes on. However, for medical device startups, we know there’s another uphill task – complying with the regulation/law.