CE Marking – An Introduction to the Medical Devices Directive

Who should attend

This introductory course is of value to employees at all levels within the organisation of Medical Device manufacturers, and suppliers to the Medical Devices industry including:

• Members of the senior management team
• Regulatory Affairs managers
• Regulatory Affairs officers
• Quality Assurance professionals
• Quality Assurance officers
• Development engineers
• Operations Managers
• Technical Sales & Marketing professionals

Book onto this course

To find out more information about this Course, please call us on +7 (495) 981 44 84.

Course Outline

CE marking is a mandatory legal requirement for all medical devices placed on the market anywhere within the EU. This course provides those new to CE marking medical devices with an introduction to the requirements of the Medical Devices Directive, including the latest update 2007/47/EC, which was mandatory from 21st March 2010.

Directives often do not make for easy reading and this course will enable you to understand the legalese and jargon to give a working understanding of the regulatory requirements.

The course will include all the major features of the Directive including, amongst others, product classification, conformity assessment routes and Technical Files including the Essential Requirements. The prime focus of this course will be on the Medical Device Directive, but will of course include reference to the IVD and AIMD directives.

Topics covered include

• Brief history of the directives
• Notified Bodies & Competent Authorities
• Harmonised standards
• Medical Device Directive 93/42/EC including 2007/47/EC amendments
• Active Implantable Medical Devices 90/385/EEC including 2007/47/EC amendments
• In-vitro Diagnostic Devices 98/79/EC (not affected by 2007/47/EC)
• Product Classification
• Conformity Assessment Routes
• Technical File (STED Format)
• Labelling
• Vigilance
• Risk Management
• Post Market Surveillance
• An appreciation, knowledge and understanding of the main requirements of the directives
• An understanding of the additional requirements for your quality management system
• Understand the role of regulatory bodies
• Mechanisms for determining device classification
• Awareness of compliance routes, based on device classification
• Outline of Technical File requirements
• Integration of Risk Management throughout
• Post production obligations

Outcomes

• An appreciation, knowledge and understanding of the main requirements of the directives
• An understanding of the additional requirements for your quality management system
• Understand the role of regulatory bodies
• Mechanisms for determining device classification
• Awareness of compliance routes, based on device classification
• Outline of Technical File requirements
• Integration of Risk Management throughout
• Post production obligations