ISO 13485 Tops Latest EU Medtech Standards List
This article was originally published in SRA
The publication of EN ISO 13485:2016, the newly revised medical device quality management systems standard, was the most significant among the list of latest EU standards published from CEN and CENELEC, the European standards institutions1.
You may also be interested in...
Medtech companies selling into the Vietnam market need to start preparing for major regulatory changes that will be introduced in 2017 via a new decree. That is the advice of Asia Regulatory Professional Association (ARPA) secretary Jack Wong and ARQon consultant May Ng, who spoke to Medtech Insight on a range of regional Asian regulatory issues for this September update.
Where are the biggest challenges for notified bodies and manufacturers now there is some experience with the MDR, and can the sector manage the new regulatory requirements successfully?
The European Commission has finally published detailed guidance on the EU IVDR’s classification rules. The IVDR’s completely new classification regime means guidance is urgently needed.