EU Officially Designates Second Notified Body Under The MDR: TÜV SÜD Enters Center Stage
TÜV SÜD, headquartered in Germany, is the second notified body to be officially designated under the EU MDR. Is this good news going to significantly lessen medtech industry’s concerns over delays in accessing the new, tougher regulatory system for medical technology, with time running seriously short?
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IVDR And Brexit Outlook For IVD Firms: EU Themes To The Fore At Asian Medtech Associations Reg Networking
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).
The impact of high regulatory demands on the innovation potential of medtech companies in Europe was a sub-theme of last week’s MedTech Forum in Paris. But it’s not a theoretical risk, for coinciding with the Forum was a decision by Swiss company Jossi Holding to close its orthopedics subsidiary.
The EU notified body association, TEAM-NB, is working hard to support industry with its MDR and IVDR compliance efforts. Its first technical documentation training session highlighted where help is likely to be most needed.