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
Delivered in-house, this 1-day practical workshop provides an awareness of the European Directive 93/42/EEC concerning Medical Devices. Knowledge of its contents is vital to seeing the relevance of the requirements placed on manufacturers, particularly the relevance of ISO 13485:2012, the quality standard for the medical device industry.
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
By the end of this training course, delegates will be able to:
- 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.
Dedicated training can occur at your premises or a venue of your choice on a date which is convenient for your team. The one-day Understanding the European Directive 93/42/ECC concerning Medical Devices course includes interactive workshops to encourage team discussions on how ideas learnt can be successfully implemented within your organisation.
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
Was very beneficial to put what I was learning into practiceI didn't expect an online course would be so interactive and it was very beneficial to put what I was learning into practice and helped a lot to have a better and clearer understanding.
P3 Medical Ltd|16th Aug, 2022
Personalised guidance/advice for delegates added a lot of value to the courseThe tutor was able to engage the group well, draw from his own experiences, and give personalised guidance/advice to delegates in a way that added a lot of value to the course.
DAM Health|29th Jul, 2022
Course provided confidence that I have been auditing in a satisfactory wayI am self taught. The course provided confidence that I have been auditing in a satisfactory way. The Tutor was very good and provided a broad range of examples.
Yourgene Health|15th Jul, 2022
Having done the course I feel confidentI was concerned about being a lead auditor so soon, but having done the course I feel confident in planning it.
Vision Rt Ltd.|13th Jun, 2022
I feel well equipped to complete audits nowI feel well equipped to complete audits now.
Cheshire Constabulary Headquarters|13th Jun, 2022
Easy to follow and clear with plenty of examplesTutor was able to make the lessons easy to follow and clear with plenty of examples.
Goodyear S.A Innovation Center|30th May, 2022
Clear and understandable contentThe content was a lot more clear than I expected it to be, more understandable.
Vision Rt Ltd.|27th May, 2022
Tutor tailored information specifically to our situationsTutor was very knowledgeable, engaging and tailored information specifically to our situations.
DSTL|25th May, 2022
Impressed by the contentThe practical workshops really helped to apply what we had learned during the course. I was impressed by how the content enabled and empowered us to apply the knowledge to real-world auditing scenarios.
Endomagnetics Ltd|23rd May, 2022
The tutor kept the mood light and engagingThe tutor was knowledgeable, friendly and had a wide range of 'real-life' stories on which to draw in order to flesh out certain aspects of the course. Above all, the tutor kept the mood light and engaging.
Deca - Defence Electronics And Components Agency|16th May, 2022
Extremely knowledgeable and patient TutorThe instructor was extremely knowledgeable, patient and found ways outside of the medical environment to explain theories; so no matter what peoples areas of expertise were, everyone would be able to understand.
Accora Ltd|16th May, 2022
This was my first Virtual training course and I was really impressedThis was my first Virtual training course and I was really impressed with the resources and the ability to still separate people into groups. The instructor can pop in to the groups to get a feel for what people are...
Accora Ltd|16th May, 2022
