European Union regulations for medical devices are under going the biggest revision since the 1990s prompting a need for medical device companies to reassess their quality management system (QMS) practices and product portfolio. Not only must new devices comply with these new regulations, but all existing products must be recertified. Students in this course take a deep dive into the details of these new regulations so they can help their organizations navigate the complex realignment.
You will learn the differences between the current medical device directive (MDD), the active implantable medical devices directive (AIMD), and the new medical devices regulation (MDR), and how you can effectively establish them in your organization. We will discuss how to meet the new requirements for clinical data and evaluation, how to scope a clinical evaluation plan (CEP) and a clinical evaluation report (CER), and strategies to meet the new post-market surveillance (PMS) and post-market clinical follow-up (PMCF) requirements. Learn to identity various economic operators in your supply chain—a new concept—and how to develop an MDR compliance plan and product strategy or portfolio rationalization.
In addition to a brief overview, topics include:
- Assessing notified bodies
- Supply chain & economic operators
- Technical documentation
- Labeling requirements under MDR
- QMS impact due to MDR
- Unique device identification (UDI), the European database on medical devices (EUDAMED), Information Technology (IT) requirements
- Clinical data and evaluation
- PMS and PMCF
- DR Implementation