The regulations focus on stricter requirements for notified bodies, stronger pre-market scrutiny and post-marketing surveillance, more stringent rules for high-risk devices and certain other categories of devices, and greater transparency and traceability.
The underlying premise for the new regulations is that all medical devices and IVDs must be safe and effective, and provide a high level of health protection for patients and users. High standards must be achieved for quality and safety of these devices. Risk management and quality management systems will be required. For implantable devices and those that are highest risk, or Class III, clinical trials must be performed unless it is an already approved device that is being modified by the original manufacturer.
The following links provide additional information on the new regulations:
Objectives of the Presentation
- REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009
- REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices
The key learning objectives include:
Why Should you Attend
- To learn about the background and rationale for the new medical device and IVD regulations
- To understand what is in scope and out of scope for both regulations
- To learn about the timing of the regulations to enable planning the steps necessary to comply
- To understand the specific elements and requirements of the regulations and how they need to be applied
- To learn the specific changes required for clinical trials to provide evidence of safety and performance in proportion to the risk associated with a given device
- To gain insight as to how to build a risk assessment and quality management system to help understand how to ensure medical devices and IVDs meet compliance requirements
- To understand the requirement of assigning a "Qualified Person" on staff who is responsible for compliance with the new regulations
- To learn about additional post-marketing surveillance requirements
- To understand how Common Specifications will be published by the EU Commission or expert panels
The agreement lays out what will be required by manufacturers, distributors, reprocessors and any other entity involved in the production, testing, distribution and sale of medical devices and IVDs. The training will enable the attendee to understand the rationale behind these regulatory changes, the scope, the timing, and the specific changes required to comply with them. In particular, companies will need to implement risk-based and quality management systems to ensure product quality and patient safety.
The attendee will learn about how they can bring their company into compliance with the new regulations to reduce risk and improve patient safety. Anyone responsible for functional areas such as manufacturing, testing and supply chain will benefit from this webinar.
Who will Benefit
- Scope of the new regulations
- Timeline for transition to the new regulations
- Emphasis on high-risk devices with greater transparency and traceability
- New requirements for manufacturers, distributors, reprocessors and independent bodies
- Additional clinical trial requirements
Employees of device manufacturers, distributors, testers responsible for:
- Quality Testing
- Quality Assurance
- Packaging and Labeling
- Clinical Testing
- Product Recall and Withdrawal
- Post-Marketing Surveillance
- Consumer/Patient Complaints and Adverse Event Reporting
- Regulatory Staff
- Audit Staff
The new regulations address the design and manufacture of devices, as well as clinical testing, authorization and post-marketing surveillance. They will have an impact on manufacturers who sell devices in the European Union (EU), and are in response to scandals over the last decade involving tens of thousands of problems from metal-on-metal hip replacements and faulty breast implants. All particularly high-risk devices, such as implants, joint replacements or insulin pumps, will require further assessments by subject matter experts before they can be authorized for sale and use.