Under the In-Vitro Diagnostics Directitve (IVDD), the majority of IVDs are self-declared devices. However, under the In-Vitro Diagnostics Regulation (IVDR) this majority 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.
With the aid of practical exercises, this course will inform delegates on regulations for IVDs, particularly the fully revised scope of the IVDR, and will highlight the key areas of change from the pre-existing Directive.
What will you learn?
Regulations under the IVDR
Gain a comprehensive insight into the latest developments outlined in the new Regulation
Classification of IVDs
Understand the new classification requirements
Key Roles & Responsibilities
Examine the roles and responsibilities of Competent Authorities, Notified Bodies, Economic Operators and the Person Responsible for Regulatory Compliance (PRRC)
Post Market Surveillance & Vigilance
Learn about the key updates to post-market surveillance and vigilance activities
Conformity Assessment Routes
Examine various conformity assessment routes under the IVDR
Who is this course for?
This course is relevant for 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
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.