As a Senior Contributor to InCompliance, many years I am asked to update my articles to be placed in the Annual Guide but rarely do 2 of my articles show up in the Guide in a year. This year 2
InCompliance Annual Guide Articles
MDCG March ’20 Meeting – Industry & Notified Bodies Provide Feedback
The Medical Device Coordination Group (MDCG) is meeting on March 11 & 12th to hold a series of meetings. Part of these meetings includes hearing feedback from industry and Notified Bodies on stakeholder preparedness for the application of the MDR
MDR / IVDR Designation 2019 Stats
EU Commission promised 20 Designations 12 Notified Bodies Designated to MDR (9) & IVDR (3*) *All 3 IVDR Notified Bodies have MDR designation as well, so that can be counted as double counting. It depends on your perspective. 2 NB’s
Standards & Regulatory Update – Medical Electrical Devices – Article
In the June issue of InCompliance Magazine I provide advice in an article on how to remain current on medical electrical device standards (including those in development) and regulatory guidance documents. I start up at the International level (IEC & ISO)
EU MDR & IVDR Have Been Published in OJEU 5 May 2017
Update of May 5 2017 Addition of the Published Documents “EU MDR & IVDR were Published in OJEU TODAY Friday May 5, 2017″ Stop the Presses and add these earth shattering Regulations to your reading list for the next week or