The European Union is implementing new medical device regulations (MDR) that are more rigorous than what the FDA requires. The design development creates new legal liabilities and will most likely cause delays in product certification for marketing.
Total Product Life Cycle (TPLC), which is FDA urged, is now required by the EU. This means corrective and preventive action programs (CAPA), complaint investigations and an annual publication of the firm’s safety and performance profile of their products becomes highly transparent. Foreign firms that import and distribute your devices have the regulatory liability that makes your recall in the U.S. and in the EU a nightmare. No more sweeping your problems under the rug.
Objectives of the Presentation
- Understand the critical role of the Total Product Life Cycle Expansion;
- Identify new adverse reporting an annual publication of safety and effectiveness problems;
- Identify critical U.S. Export requirements;
- Regulatory liability of initial importers and distributors; and
- Explain new qualification requirements for auditors and their staff.