EU Medical Device Regulatory Affairs explained Simply
What you'll learn
- Understand how Medical Device Regulation works in the European Union.
- Differentiate between a regulation and a directive.
- Steps required to gain permission to manufacture and sell a medical device in the European Union.
- Explain the roles and responsibilities of a Competent Authority & a Notified Body with regard to European Union regulation.
- Understand in simple terms the Active Implantable Medical Device Directive 90/385/EEC.
- Understand in simple terms the Medical Device Directive 93/42/EEC.
- Understand in simple terms the In Vitro Diagnostic Medical Device directive 98/79/EEC
- Understand the difference between the directives and the new Medical Device Regulation, MDR EU 2017/745(MDR) & EU 2017/746 (IVDR).
- How to obtain CE Marking.
- Classification of medical devices in the European Union.
- What part does ISO 13485 2016 play in the European Union regulation system.
- Understand the part that Manufacturer, the Authorized representative and the EFTA play in the European Union regulation system.
- Brexit understand the impact to the European Union regulation.
- Understand the transitional time lines from the directives to the medical device regulation.
- Understand regulatory affairs
Each lecture is explained in simple format. If the student takes each lecture step by step, they will understand how a company gains permission to manufacture a medical device which will be allowed to be sold in Europe. This module is ideal for a person who wants to work in medical device regulation, who wants to be involved in a medical device start up or who wants to be involved in the medical device industry either in operations, quality, engineering, marketing and research/development. If you are a student who wants to understand the rules that govern the sale of medical devices in the European Union Market place this course is perfect for you. If you are a medical device manufacturer outside the European Union and would like to sell your product in Europe this course is ideal for you. You will understand how important the ISO 13485 2016 standard is to gain market approval.
The following topics will be covered:
´Difference between Regulation and a Directive.
´Steps required to get permission to manufacture and sell a medical device in Europe.
´MDD 90/385/EEC Active Implantable Medical Device Directive.
´MDD 93/42/EEC Medical Device Directive.
´MDD 98/79/EEC The directive of In Vitro Diagnostic Medical Devices .
´MDR EU 2017/745(MDR) & EU 2017/746 (IVDR).
´CE Marking approval process.
´Classification of medical device. Including the MDR 2017 745 classification.
´ISO 13485 2016
´Other players the Manufacturer, the Authorized representative and the EFTA.
Each lecture has a quiz that will enable students to understand the learner outcomes
Brexit understand the impact to the European Union regulation.
Understand the transitional time lines from the directives to the medical device regulation.
Who this course is for:
- Medical Device Engineers
- Quality control within the medical device industry
- Operation Managers within the medical device industry
- Entrepreneurs in setting up medical device technologies.
- Quality Control Technicians
- Process Engineers
- Quality Control Engineers
- Marketing within the medical device industry.
- Research and Development Engineers within the Medical device industry
- Students in Biomechanical Engineering.
- Students in Pharmaceutical science.
- Students in Regulation affairs.
- Students in Quality Assurance and quality control.
- Internal and external audits of the medical device Industry
- Medical device manufacturers inside and outside of Europe.
I have over 20 years experience working in high volume manufacturing. I have worked in the semiconductor business for 10 years. I worked in the life science industry in particular the medical device industry. I have worked for European and America companies in these sectors. I have worked in research and development in the medical device industry and thought in the academic arena in the last 5 years. I have thought operations management, quality, lean and regulation. I have extensive on experience carrying out industry projects on lean, six sigma, quality control and validation. I have extensive operational management experience.