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
Follow link to join the event: https://www.pcbc.gov.pl/pl/uslugi/szkolenia/szkolenia-specjalne/szkolenie-online-o215-przeglad-rozpo...