Understanding the European Directive 93/42/EEC concerning Medical Devices
DURATION
1 dayCPD
Equivalent to 8 hoursCERTIFICATES
All delegates will receive a certificate on completion.DELIVERY OPTIONS
This workshop will develop knowledge of the Articles and Annexes of the Directive and points the way to other sources of documentation. It provides a detailed overview of the Directive and the relevance of the Directive to Medical Device manufacturers in manufacturing CE marked medical devices. Regulatory Bodies and their roles are defined in the directive, together with classification criteria and the routes to EC Declaration of Conformity and the use of the CE Mark
- Expectations of the EU in applying risk analysis to medical devices
- Scope of the European Directive 93/42/EEC, its 22 articles and 12 annexes
- The roles of the bodies defined in the Directive, particularly the MHRA
- The allowed paths to be able to use a Declaration of conformity and the CE mark
- The Essential Requirements and the role of risk assessment
- Incident reporting requirements and the role of post production surveillance
- Classification criteria and clinical evaluation requirements
- Sources of information and further guidance
- General Managers / Business Unit Managers
- Quality and Regulatory Professionals
- Management representatives / Internal and External Auditors
- Those seeking an understanding of the Directive
- Apply the articles of the European Directive 93/42/EEC and follow the acceptable paths to enable the use of a Declaration of Conformity and the CE Mark.
- Apply risk evaluation and risk control principles to their devices which affect decision making on the acceptability of risks in bringing a device to market.
Course Delivery
This course is available on a dedicated basis. Please contact our team on 0333 123 9001 to discuss scheduling training on your preferred date at your premises, a venue of your choice or within our virtual classroom.
Customer reviews
P3 Medical Ltd|16th Aug, 2022
DAM Health|29th Jul, 2022
Yourgene Health|15th Jul, 2022
Vision Rt Ltd.|13th Jun, 2022
Cheshire Constabulary Headquarters|13th Jun, 2022
Goodyear S.A Innovation Center|30th May, 2022
Vision Rt Ltd.|27th May, 2022
DSTL|25th May, 2022
Endomagnetics Ltd|23rd May, 2022
Deca - Defence Electronics And Components Agency|16th May, 2022
Accora Ltd|16th May, 2022
Accora Ltd|16th May, 2022