Medical Device Regulation 2017/745 EU regulatory affairs.
What you'll learn
- Understand European Union regulatory affairs for marketing a medical device in the EU.
- Why was there a change from the directive to the MDR 2017 745?
- The timelines for the transition of the MDR 2017 745.
- Economic Operators and their obligations. European Authorised Representative, Distributor, Importer, Manufacturer and procedure pack & systems providers.
- What is the obligation of a person responsible for regulatory compliance (PRRC)
- Understand what EUDAMED is. What the requirements are and transitional timelines. The actors registration.
- Unique Device Identification and registration. How a UDI carrier is created. Authorised UDI providers and the timelines to package device with the UDI carrier.
- The student will learn how to classify a medical device with examples, quizzes and guidance documents.
- The student will learn how to choose a conformity assessment route for each particular classification of a medical device.
- Learn what is sufficient clinical data and how to collect it. What is meant by intended purpose and General Safety and performance requirements. (GSPR)
- Learn the requirements of post market surveillance. What a periodic safety update report (PSUR) is. The student will learn the requirements of vigilance.
- The student will learn the role of the medical device coordination group. MDCG
- Learn what common specification and technical documentation means.
- Understand the implications of Brexit on the MDR 2017/745.
- Understand how Switzerland, Turkey and the EFTA are affected by the MDR 2017/745.
- Understand what the EU commission rolling plan is.
- The MDR 2017/745 will help the student how to be compliant to ISO 13485 and a Quality Management System for a medical device manufacturer.
Requirements
- A desire to understand Medical Device Regulation in simple terms
Description
This Course is broken into nine sections. The objective of the course is to explain the medical device regulation 2017/745 in simple terms:
Section 1 Introduction.
Introduction to the Medical device regulation 2017 745.
Why was there a change from the directive to the MDR 2017 745?
The timelines for the transition of the MDR 2017 745. How the COVID pandemic has impact these timelines
Section 2 Economic Operator.
Economic Operators. Who are they?
Economic Operator. The European Authorised representative. Explain their obligation.
Economic Operator. The Distributor. Explain their obligation.
Economic Operator. The Importer. Explain their obligation.
Economic Operator. The Manufacturer. Explain their obligation.
Economic Operator. The Procedure pack & Systems Provider. Explain their obligation.
When does an Economic operator obligation change?
Explain the obligation of a person responsible for regulatory compliance
Section 3 EUDAMED
Introduction to what EUDAMED is.
Understand what is meant by the actor registration.
The timelines for the transition of EUDAMED system
Section 4 Unique Device Identification and registration
UDI Introduction Part 1. What is it? Why is it needed?
UDI Part 2. Understand the unique device identification carrier.
UDI Part 3. Understand who the current accredited organisations are that can create Unique Device identification carrier standards.
UDI timelines. When the UDI carrier needs to be attached to the packaging and devices.
Section 5 Classification of medical devices
Classification of medical devices Introduction.
Qualification of medical devices. Determine if the manufacturer is making a medical device.
Understand medical device definitions. This will help the student how to classify a medical device.
Rules of medical device classification. Understand the implementation of the rules.
MDR apply medical device rules.
Section 6 Conformity assessment
Explain the Conformity assessment path for a Class I medical device
Explain the conformity assessment path for a class I s, I m & I r medical device.
Explain the conformity assessment path for a Class II a medical device.
Explain the conformity assessment path for a Class II b medical device.
Explain the conformity assessment path for a Class III medical device
Section 7 Sufficient Clinical data
The General Safety and Performance Requirements.
The Intended purpose.
Sufficient clinical Data. Clinical Evaluation.
Post Market Clinical Follow up (PMCF).
Section 8 Post Market Surveillance.
Post Market Surveillance.
Post-market surveillance report & Periodic safety update.
Post-market vigilance.
Analysis of vigilance data.
Role of Competent Authority & European Commission within Market Surveillance
Section 9 Other Items
Medical device coordination group
Brexit
Swizterland Mutual Recognition Agreement
Turkey and EFTA agreement with the EU.
Common Specifications
The Rolling plan.
The benefits of the course will be:
Save you time.
Really understand regulation in simple terms.
Help you prioritizes work to prepare for the MDR 2017 745 timelines.
Understand why regulation was introduced.
Know your obligation to the MDR 2017 745.
Know the obligation to EUDAMED and the timelines.
Examples of how Unique Device Identification carriers are created.
Worked examples how medical devices are classified.
Know the conformity assessment route to take for each medical device.
Know what sufficient clinical data to collect to be compliant.
Understand the market surveillance requirements to allow the medical device to stay in the market place.
Understand the UK and EU manufacturers responsibility post Brexit.
Understand Turkey and the EFTA (Switzerland, Liechtenstein, Norway and Iceland) manufacturers responsibility regarding the MDR 2017 745.
Who this course is for:
- Medical Device Engineers
- Quality control within the medical device industry
- Operation Managers within the medical device industry
- Entrepreneurs or small medium start-up companies that need to develop a new medical device.
- Quality Control Technicians
- Process Engineers
- Regulatory Affairs.
- 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 auditors of the medical device Industry
- Medical device manufacturers inside and outside of Europe.
- Professionals engaged in ISO 13485 and Harmonised Standards within the European Union Market Place.
- Small start companies who want to develop new products in the Medical device industry
- Process and Development Engineers.
- People managers within the Medical device and health care industry.
- Manufacturing Engineers.
- Students who need to really understand the medical device regulation 2017 745 in simple terms.
- Health care providers. (Doctors and Nurses for example)
- Professionals involved in pre clinical medical devices studies
- Professionals involved in clinical trials of medical devices.
- Professionals involved in Post market surveillance of medical devices.
- Economic Operator The manufacturer.
- Economic Operator The distributor.
- Economic Operator The European Authorised Representative.
- Economic Operator The Importer.
- Economic Operator The Procedure Pack and Systems provider
Instructor
- 4.4 Instructor Rating
- 4,666 Reviews
- 12,522 Students
- 7 Courses
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 taught in the academic arena since 2017. 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.