In-Vitro Diagnostic Device Regulation (IVDR) Implementation
A two-day course providing details of the new IVDR which replaces the existing IVDD (In Vitro Device Directive 98/79/EEC). This course is intended for enterprises who already manufacture products against the existing IVDD or whose products are now affected by the introduction of the new IVDR. It can be delivered as either a public or in-company event but is seen as particularly attractive as in-company where the content can be tailored to suit the needs of the organization.
You need this course if...
- You have a regulatory / quality role, or research / design / development role, or an internal / external auditor role, or another role having a remit concerning the IVDR, and you want to be able to apply the requirements of the IVDR.
You will be able to…
- Explain the European CE marking approach for IVDRs including its legal and operational basis.
- Describe the structure and scope of the IVDR including classification and conformity routes.
- Apply the essential requirements including labelling and develop suitable technical documentation.
- Identify the regulatory significance of risk management and process validation.
- Combine knowledge gained from the course with audit qualifications to conduct compliance audits of your own organization and suppliers.
- Create technical documentation to support the product throughout its life cycle.
- Explain the role and importance of performance evaluation including application of the Common Technical Specification (CTS).
- Interpret the criteria for reporting adverse incidents under the vigilance system.
- Define the manufacturers regulatory responsibilities, including reporting of changes to products and QMS system to the Notified Body.
You will need…
- To possess a basic knowledge of quality management systems for the IVDR industry and / or experience of the manufacture, design, marketing or use of in-vitro diagnostic devices (IVDs).
- Ideally to have attended LRQA’s Introduction to the In-Vitro Diagnostic Device Regulation (IVDR) training course prior to attending this training course.
Your future development
- Introduction to the MDR
- MDR Implementation
- Auditor training
Dates and Locations