On October 14, Anna Mirek from Noerr will hold a special online training about EU invitrodiagnostics regulation designed for meddevice companies. The 1-day training will focus on the review of the In-vitro Diagnostic Regulation (IVDR), a practical explanation of new requirements and consequences of non-compliance. Understanding these new regulatory requirements will help you in leveraging a market position.
Anna Mirek will discuss with you following topics:
1. Products and subject scope governed by the Regulation
2. Why did we come from the Directive to the Regulation – the scale of a change
3. Putting a device into service – obligations of market players
4. Key changes – what are the differences vs MDR?
5. What’s new?
6. UDI, Performance evaluation, labelling requirements and a lot more
7. Vigilance and PMS obligations
8. Enforcement of the Regulation under Polish law and penal provisions
9. Timeline and transitional provisions
10. Discussions
Follow link to join the event: https://www.pcbc.gov.pl/pl/uslugi/szkolenia/szkolenia-specjalne/szkolenie-online-o215-przeglad-rozpo...