This webinar will discuss main differences between current EU Medical Device Directive (MDD) 93/42/EEC and new EU Medical Device Regulation (MDR) 2017-745 and how to ensure compliance with the new MDR requirements that will be mandatory starting May-2020.
The webinar will discuss in detail how to address the gaps between MDR and MDD in the areas of:
Why Should You Attend:
Only medical device companies that are in compliance with the new Medical Device Regulation (MDR) 2017-745 will stay in the European market after 26-May-2020. It's key to understand the gaps with the previous Medical Device Directive (MDD) 93/42/EEC and how to remediate them to continue business in the 2nd (about 30 % worldwide volume) worldwide medical device market.The webinar will discuss in detail how to address the gaps between MDR and MDD in the areas of:
- Device classification
- Conformity routes
- General Safety and Performance Requirements (GSPRs)
- Technical documentation
- Post market surveillance (PMS)
- Clinical evaluation
- UDI
- EUDAMED
- Economic operators
Areas Covered in the Webinar:
- Device classification
- Conformity routes
- General Safety and Performance Requirements (GSPRs)
- Technical documentation
- Post market surveillance (PMS)
- Clinical evaluation
- UDI
- EUDAMED
- Economic operators
Who Will Benefit:
- Quality Assurance Managers/Directors/VPs
- Regulatory Compliance Managers/Directors/VPs
- Regulatory Affairs Managers/Directors/VPs
- Clinical Managers/Directors/VPs
- Medical Device industries conducting or planning to conduct business in the European Union
- Free Materials:
- Reference documents
Course Provider
Juan M Campos,
