The EU’s MDR means big changes for devices with non-medical purposes. The clock is already ticking, don’t miss out on the opportunity.
EU Regulation 2017/745, created with the key aim of protecting public health, has many important implications for products with non-medical purposes. This list of products includes cosmetic lenses, aesthetic implants, subcutaneous fillers, lifting threads, liposuction and lipolysis equipment, lasers and other electronic devices for aesthetic applications.
By May 2020 every device will need to comply with the MDR including the CE Marking procedure. All must conform to the same strict safety standards applied to similar medical devices. Our free webinar is here to help manufacturers prepare.
Manufacturers must start to consider their obligations under MDR at the earliest opportunity. This will include holding comprehensive technical documentation supported by tests and clinical data for ensuring stringent safety standards. They will also need to establish Quality Management and Risk Management Systems, while being constantly aware of market feedback. Our webinar will tackle these points, focusing on:
- Legal landscape and timelines
- Manufacturers’ responsibilities and to-do’s lists
- General safety and performance requirements (including applicable technical standards)
- Classification and conformity assessment procedures
- Quality Management (ISO 13485) and Risk Management (ISO 14971)
- Post market vigilance and surveillance system