This month’s Asian Medtech Associations Regulatory Networking discussions is split into two parts, the first being a guest presentation on EU themes, specifically a UK Brexit outlook and an update on the progress of the EU IVDR, which comes into full effect on 26 May 2022. Both have potentially far-reaching effects for Asian and other global medtech markets. Part two will feature AHWP and Asean updates, as usual. This editorial feature is hosted by Medtech Insight, along with the Asia Regulatory and Quality Consultancy (ARQon) and the Asia Regulatory Professionals Association (ARPA).
As far as EU medtech regulations are concerned, most of the talk and almost all of the fears surrounding the lack of readiness of both the new system and of its users are coming from medical devices stakeholders. On the surface, the IVD industry seems relatively unflustered; and some of the smaller IVD firms are not even aware of how they will be impacted by it.
The worry for people like Simon Richards, who is the former chair of the British In Vitro Diagnostics Association (BIVDA) and now sits on its board,is that IVDs will be...
