Since the European Commission released a proposal for the new European medical device regulations in September 2012, industry has been attempting to gain a firm idea of what needs to be done to ensure preparation and compliance.
Informa Life Sciences' 9th Annual European Medical Devices Regulation conference provides a comprehensive update on recent and impending changes with the proposed regulation to ensure that you are fully prepared.
2015 conference highlights include:
- Notified Body perspective: Practical experience with carrying out unannounced audits on manufacturers
- Real life industry experience: Changes in Notified Body practices
- Understanding changing responsibilities of economic operators and how to manage unannounced Notified Body audits on critical subcontractors and suppliers
- Pharmaceutical perspective: Understanding the role of the Qualified Person with practical advice on preparing for these changes
- Understanding medical device classification and reclassification changes with the proposed medical devices Regulation
- A regulatory update and practical implementation of the Unique Device Identifier (UDI) system in Europe, the US and globally
- Outlining key changes to the medical device post market surveillance and vigilance system
- Exploring increased technical file and product testing requirements with the proposed medical devices Regulation
- Determining the role and accessibility of the Eudamed database and key changes associated with the proposed medical devices Regulation
- Examining the regulation of software as a medical device and impact of the proposed Medical Devices Regulation
- Outlining how the proposed medical devices Regulation is extended to include products manufactured using non-viable human tissues or cells