Day 1:

• Introduction to the new MDR – why was a revision needed? Timelines – transition periods – validity of certificates – Status of Notified Bodies.
• Scope of the MDR (Article 1) – What products are covered and which not.
• New/revised important definitions (Article 2) and Eudamed – what is it, what do you need to do as manufacturer.
• Economic Operators: Manufacturer, Authorized Representative, Importer and Distributor (M.A.I.D.) – their roles, rights and responsibilities and what actions do you need to take as manufacturer towards them.
• Impact for Health Institutes in the EU – challenges regarding “home brew” devices made by hospitals and reprocessing of single use devices.

Day 2:

• Classification and Conformity Assessment routes – what has changed and how will it impact you as manufacturer
• QMS requirements – including comparison to ISO 13485:2016
• Annex I: General Safety and Performance Requirements  many more requirements are written down. But how new are they? Including label and IFU requirements.
• Annex II: Technical Documentation requirements: How to present the technical documentation to the authorities (incl. Notified Bodies), including Clinical evaluation and PMCF requirements – how to keep it practical (is that still possible?).
• Post Market Surveillance: Planning, executing and reporting, including adjusted vigilance and FSCA requirements.

This course will be extremely useful for the persons working in regulatory and quality assurance departments, and equally important for project managers or CTO’s involved in development of new medical devices. Last but not least, as CEO of a medical device company, you will obtain a clear insight in the new EU requirements and the impact it will have on your business case or company.

At the end of the seminar, you will be able to draft your company’s action plan, enabling working towards EU MDR compliance throughout the lifecycle of a medical device.