Newly Proposed EU Medical Device Regs Understanding the 7 Big Changes That Could Impact Your Device
The EU has been in turmoil lately from recent breast implant and metal-on-metal joint replacement scandals and the resulting public outcry. In response, the EU Commission has proposed major changes to the current regulatory framework for medical devices in the EU. These stricter regulations could lead to:
- New rules for some never-before-regulated products
- Significant new measures to improve traceability and transparency — including UDI
- Longer delays in marketing approvals due to high-risk devices having to pass scrutiny of the Medical Devices Coordination Group
- Newly introduced clinical trial requirements that require manufacturers to have a trial “sponsor”
- Strict new rules on the reprocessing of single-use devices — including NO reprocessing of single-use devices for critical use
- Parallel importers required to put in place a Quality Management System for repackaging and relabeling — but do NOT have to re-apply for a CE-mark
- New software (both incorporated and standalone) requirements for IVDs (genetic tests, companion diagnostics and medical software)
How could your company and device be affected? Are you ready?
The new regulations are written to be directly applicable in all EU Member States. These new regs, are NOT directives that must be implemented into each member state’s national laws.
This is good news for firms that have their act together. It means a unified regulatory structure that avoids having to comply with individual member state rules. BUT, for firms that fail to address the new regs it means trouble in ALL EU member states.
What you need is an experienced guide to help you understand what’s required in the 7 major changes and to answer your specific questions.
FDAnews is proud to have Peter Bogaert, an expert on regulatory issues in the EU, on hand to sort out the confusion. In just 90 minutes Mr. Bogaert walks listeners through the complex proposed changes and how they could affect the current regulatory framework for medical devices.
If you seek approval or sell medical devices in any EU member state, you can’t afford to miss this training session CD and transcript. Don’t delay.
Newly Proposed EU Medical Device Regs listeners will learn:
- Why the EU created these regs as directly applicable to all EU Member States and what that means for your EU regulatory policy
- Examples of the new products now under EU device regulation — and some products explicitly excluded
- How to comply with the significant new traceability and transparency requirements including UDI
- A requirement that device manufacturers be able to identify all “actors” within their supply chains
- If the door has been opened for sponsors to submit a single application for a multi-state trial
- What new data must be fed into Eudamed regarding all operators and their products
- Overview of the new requirement that high-risk device manufacturers must publish a summary of key their clinical trial data
- What’s this newly proposed EU portal that will publish all serious adverse events for high-risk devices?
- Notified bodies must now inform the Medical Devices Coordination Group (MDCG) of any new applications for high-risk devices and the MDCG may require additional reviews and data
- Understanding the strict new rules surround reprocessing
- If your parallel importing program is in jeopardy. How to comply with new QSM requirements
- A new IVD classification system, software requirements and coordination with drug authorities or EMA