A two-day course providing details of the new MDR which replaces the existing MDD (Medical Device Directive 93/42/EEC) and AIMDD (Active Implantable Medical Device Directive 90/385/EEC).
This course is primarily intended for enterprises who already manufacture products against the existing MDD. It can be delivered as either a public or in-house event, when delivered in-house the content can be tailored to suit the needs of the organisation.
Who should attend?
Individuals responsible for regulatory compliance working in an organisation involved in any aspects of medical device manufacturing, designing, marketing or the supply chain.
What will you learn?
- The requirements of EU 2017/745
- The European regulation CE marking approach for medical devices including its legal and operational basis
- The structure and scope of the MDR including classification and conformity routes
- The safety and performance requirements checklist applicable to CE market
- To create technical documentation to support the product throughout its life cycle
- The level of clinical evidence necessary to demonstrate conformity
- To develop a robust and proactive post market surveillance system under the new MDR including vigilance reporting and monitoring
- The regulatory significance of a robust quality management and risk management system
- To gather the business impacts of the regulation and start to develop a transition plan.
What do you need to prepare?
- Basic knowledge of medical device manufacturing, design and marketing with a detailed understanding of quality management systems
- Ideally to have attended LR’s Introduction to the IVD Device Regulation (IVDR) prior to attending this training course.
- Training course materials
- Lunch and refreshments for public attendees only
- Certificate of attendance.