Content
If companies produce in-vitro diagnostics in their medical laboratory and use them for human diagnostics, so-called in-house IVDs, then as a healthcare facility they are legally obliged to comply with relevant aspects of the IVDR, which apply uniformly across the EU.
This half-day seminar provides a regulatory overview of the specific requirements. The participants learn about the timeline for implementing the requirements and can derive internal measures from this in order to continue operating the in-house IVDs in accordance with IVDR in the future.
Medical laboratories are also influenced by the IVDR as operators and users of CE-marked IVDs. The participants also understand the meaning and impact of the IVDR on their organization from this perspective.
Topic overview
- Legal framework for in-house products according to IVDR
- Important definitions (e.g. healthcare facility, in-vitro diagnostic device)
- Requirements from Article 5(5).
- Timeline – gradual start of validity
- Market surveillance by responsible authorities
- Regulatory changes from the perspective of operators and users
target group
Specialists and managers from medical laboratories, employees from quality management and regulatory affairs.
Prior knowledge
Not required (basic seminar).
Notice
The seminar “In-house IVD – Implementation of IVDR in medical laboratories” will take place on October 1st, 2024.
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
Online
