ESSENTIAL EU MDR REQUIREMENTS - MINIMIZE THE RISK OF NON-COMPLIANCE

🎤 Edwin Waldbusser ‎ | 📅 March 28, 2023 | 🕒 11 AM Eastern Time US

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