The In-Vitro Diagnostic Regulation (EU) 2017/746, which came into force in May 2017 with a transition period of five years, is intended to strengthen the current approval system for in-vitro diagnostics and makes substantial changes to the existing IVD Directive (98/79/EC) legislation.
The Regulation introduces a new risk-rule classification system based on the Global Harmonization Task Force (GHTF) rules which, for the first time, takes patient impact into consideration. This will have a significant impact on all manufacturers of IVDs as about 80 per cent of all devices will now require some form of conformity assessment by a Notified Body.
This seminar will clarify the requirements applicable to in-vitro diagnostic devices under the new Regulation, highlight the major changes to responsibility and product data expectations and provide a thorough understanding of the impact on the industry.
Practical workshops over the two days will help consolidate the information provided.
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Course Content
Day 1
Introduction to IVDs
- Definition of an IVD
- Why are IVDs regulated separately?
- Investigating standards and their use
- Exploring CE marking
Historical overview of the current IVD Directive (98/79/EC)
- Examining the structure and content of the IVD Directive
Introduction to IVD Regulation (EU) 2017/746
- How did we come from the Directive to the Regulation?
- Main drivers for change
- Scale of change
- Structure and Annex
Notified Bodies
- How has the role of the Notified Bodies changed under the IVD Regulation?
- Conformity assessment
IVD Regulation - key changes
- Persons responsible for regulatory compliance
- Economic operators, importers, distributors
- UDI
- Software
- Intended use/intended purpose
- (including an interactive workshop)
- Performance evaluation
- Clinical evidence
Compiling the technical documentation for an IVD
- Structure and content of STED
- Technical file vs design dossier
Labelling requirements and strategies
- Understanding electronic instructions for use (e-IFUs)
- Use of language and symbols
- Translation requirements
- Traceability and EUDAMED
- UDIs
Day 2
ISO 13485:2016
- Introduction to ISO 13485
- Key changes from 2012 to 2016
- Where does it fit with IVDD & IVDR?
Risk-based classification
- How are IVDs classified?
Workshop: Product classification
- Discussion on the classification of example IVDs
Risk management
- Regulatory requirements
- ISO14971
- Usability
Workshop: Risk management
Clinical evidence and common specifications
- Scientific validity vs performance evaluation
Vigilance and PMS
- Regulatory requirements
- Incident reporting/FSCA management
Case studies: Reporting/recalls
- PMS
Key timelines and practical considerations
Discussion: Preparing a roadmap for transition
