Essential EU MDR Requirements - Minimize the Risk of Non-Compliance

The EU MDR replaced the MDD and expands the conformance requirements. Several parts of the MDR have been delayed for several years. New requirements are added and existing requirements are expanded. Emphasis is placed on lifecycle control and post market analysis. Reliance on “Substantial Equivalence” is discouraged. UID requirements are added. The supply chain has increased legal and regulatory responsibility.

Products intended to be imported into the EU must conform to these new regulations. Arrangements must be made with a Notified Body, an Authorized Representative and a Person Responsible for Regulatory Compliance. There is extensive preparation necessary.

Areas Covered in the Session:

• EU MDR objectives
• QMS requirements
• Device classification changes
• Documentation requirements
• Clinical evaluation requirements
• UDI and labelling requirements
• Post market surveillance
• New Notified Body obligations
• Human Factors/ Usability requirements

Who Should Attend:

• Engineering Departments
• Regulatory Affairs Departments
• Quality Assurance Departments
• Marketing Departments
• Management
• Importers of medical devices
• Distributors of medical devices

Course Director: Edwin Waldbusser

Edwin Waldbusser retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems and inhalation devices. His QS experience includes, design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/non-conforming product programs. He now consults in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis. Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.