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
Course Provider
Stuart Angell,
Director ,
IVDeology LtdStuart Angell, This MDTI expert is a joint director in his own consultancy specialising in global regulatory affairs strategy and compliance for in vitro diagnostics and medical devices focusing on the transition to the new IVD/Medical Device Regulations, MDSAP and ISO13485:2016.
He has over 15 years in the IVD industry and in previous roles has been responsible for designing, reviewing and maintaining regulatory frameworks for self-declared and annex list II products including technical documentation for EU and global submissions (FDA, Health Canada, TGA, Russia, Latin America). He has an excellent understanding of risk management, Post Market Surveillance (PMS) and vigilance.
Who Should Attend
- Regulatory affairs personnel
- Persons responsible for regulatory compliance
- Quality assurance professionals
- Those responsible for OEM/subcontractor control of IVDs
- Economic operators, importers, distributors
