Fundamentals of the EU IVD Regulation
The in-vitro diagnostic sector has undergone a regulatory transformation, similar to that seen in medical devices. Under the existing Directive, the majority of IVDs are self-declared devices. However, under the In-Vitro Diagnostics Regulation (IVDR) they will require some form of conformity assessment by a Notified Body. The soon-to-be implemented Regulation is drastically different to the current Directive as it imposes new requirements on manufacturers and other economic operators on areas such as conformity, device classification and documentation which impact the entire device lifecycle.
This 5-week course will inform you of the full revised scope of the IVDR and will highlight the key areas of change from the pre-existing Directive. Once completed you will be better placed to carve out a strategy to manage transition, ensuring your organisation and its product(s) remain compliant. To support you in the learning process you will have access to case studies to illustrate this theory in practice.
Suitability - Who should attend?
This course is relevant to those moving into, or new to IVD regulatory affairs within an IVD company, such as:
- Regulatory Affairs
- Clinical Affairs
- Quality Management
- Project Management
- Quality Assurance
- Professionals looking for a complete update on the IVD requirements
- Anyone looking to obtain or enhance their understanding of the IVD requirements
Outcome / Qualification etc.
- Gain a comprehensive insight into the latest developments outlined in the new Regulation
- Understand how to classify your device and distinguish it from others
- Examine the roles and responsibilities of Competent Authorities, Notified Bodies and Economic Operators
- Critically analyse the various conformity assessment routes
- Learn about the key updates to post-market surveillance and vigilance activities
- Recognise the differences between a technical file and a design dossier and how to compile them
- Study the updated labelling and CE marking requirements for your device
Training Course Content
- Module 1: Introduction to IVDR
- Module 2: General Safety and Performance Requirements
- Module 3: Documentations, Clinical Evidence and Clinical Performance of Devices in the EU
- Module 4: Post-Market Surveillance (PMS) and Vigilance Responsibilities
- Module 5: Compiling your Technical Documentation
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PTI - Pharmaceutical Training International - Training for the Pharma Industry
PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...
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