Note: The EU intends to replace the current directives on medical devices with a set of regulations. The negotiations are ongoing and behind schedule. This seminar covers the directives, but provides also provides information on the proposed regulations.
Medical devices marketed in the European Union must follow the Medical Device Directive (MDD); IVD device and active implantable devices have other directives. The MDD can be complicated, especially for US companies, because the MDD’s approach is different from the regulatory approach in the US. For example, under the MDD your company makes “submissions” to a private company that you hire, not to a government agency.
In addition, requirements are constantly changing in the European Union. For example, the harmonized standards for quality systems and risk management (EN ISO 13485:2012 & EN ISO 14971:2012) are confusing for device manufacturers to implement. The need to keep product documentation current with updates to the harmonized standards provides an additional resource need on device manufacturers.
Understand the role of product directives in the EU
Learn the MDD medical device classification system and how to apply it
Comprehend the conformity assessment paths and how they apply to particular devices
Understand the MDD Essential Requirements and how to document compliance
Learn the role of EN ISO 13485:2012 as the fundamental Quality Management System
Understand the requirements for Risk Management and the use of EN ISO 14971: 2012
Who will Benefit:
This course benefits anyone involved in quality or regulatory compliance for medical devices marketed in the European Union and is ideal for quality, regulatory, and clinical professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors.
Quality Managers and Directors
Export Compliance Managers
Use coupon code NB5SQH8N and get 10% off on registration.