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 organisation.
You need this course if...
You are jointly or fully responsible for regulatory compliance working in an organisation involved in any aspects of in vitro diagnostic device manufacturing, designing, marketing or the supply chain and you want to be able to apply the requirements of IVDR.
At the end of the course, you will be able to…
- Apply the requirements of EU 2017/746
- Explain the European regulation CE marking approach for medical Devices including its legal and operational basis.
- Describe the structure and scope of the IVDR including classification and conformity routes.
- Review the safety and performance requirements checklist applicable to CE marking under the new regulation.
- Create technical documentation to support the product throughout its life cycle.
- Understand the level of clinical evidence necessary to demonstrate conformity.
- Learn how to develop a robust and proactive post market surveillance system under the new IVDR including vigilance reporting and monitoring.
- Identify the regulatory significance of a robust quality management and risk management system.
- Gather the business impacts of the regulation and start to develop a transition plan.
You will need...
- To possess a basic knowledge of medical device manufacturing, design and marketing with a detailed understanding of quality management systems.
- Ideally to have attended LRQA’s Introduction to the Medical Device Regulation (MDR) training course prior to attending this training course.
Your future development
- MDR Introduction
- MDR Implementation
- ISO 13485:2016 courses
- ISO 14971:2012 courses
Dates and Venues