IIRF Online > Business > Industry > Medical Device Development > Medical Device Regulation 2017/745 EU regulatory affairs.
Medical Device Regulation 2017/745 EU regulatory affairs. by Udemy
Understand regulations for medical devices in simple terms to gain market approval of a medical device in the EU.
Course Highlights
- 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.
Skills you will learn!
Curriculum
6 Topics
Section 1 Introduction
Introduction
Why change?
Why change?
Timelines
Timelines for the introduction of the MDR 2017/745
17 Topics
Section 2 Economic Operators
Economic Operators
Economic Operators
Economic Operator: The European Authorised Representative.
Economic Operator: The European Authorised Representative.
Economic Operator: The Distributor
Economic Operator: The Distributor
Economic Operator: The importer
Economic Operator: The importer
Economic Operator: The manufacturer
Economic Operator: The manufacturer
Economic Operator: Procedure pack & Systems Provider
Procedure pack & systems
Economic Operator: Obligation change
Economic Operator: Obligation change
Person Responsible for Regulatory Compliance
Person Responsible for Regulatory Compliance
6 Topics
Section 3 EUDAMED
EUDAMED Introduction
EUDAMED Actors registration
EUDAMED Actors registration
EUDAMED Timelines
EUDAMED Timelines
9 Topics
Section 4 UDI/Registration
UDI Part 1 Introduction
UDI Part 1 Introduction
UDI Part 2
UDI Part 2
UDI Part 3
UDI Part 3
UDI Timelines
UDI Timelines
11 Topics
Section 5 Classification of medical devices
Classification of medical devices Introduction
Classification of medical devices Introduction
Qualification of a medical device
Qualification of a medical device
Medical device definitions
Medical device definitions
Medical device classification rules
MDR Rules of Medical device classification
Apply Medical Device Rules
Apply Medical Device Rules
11 Topics
Section 6 Conformity assessment
MDR Class I Conformity Assessment Route
MDR Class I Conformity Assessment Route
MDR Class I r Class I m Class I r and Class II a conformity Assessment
MDR Class Ir Class I m Class r conformity assessment route
MDR Class II a conformity assessment route
MDR Class II a conformity assessment route.
MDR Class II b conformity assessment route
MDR Class II b conformity assessment route
MDR Class III conformity assessment route
MDR Class III conformity assessment route
9 Topics
Section 7 Sufficient Clinical Data
General safety and performance requirement
General safety and performance requirement
Intended Purpose
Intended Purpose
Sufficient Clinical Data. Clinical Evaluation
Sufficient Clinical Data. Clinical Evaluation
Sufficient clinical Data. Post market clinical follow up.
Sufficient clinical Data. Post market clinical follow up.
11 Topics
Section 8 Post Market Surveillance
Post market surveillance system & plan.
Post market surveillance system & plan.
Post market surveillance report and Periodic safety update report
Post market surveillance report and Periodic safety update report
Vigilance system
Vigilance system
Analysis of vigilance data
Analysis of vigilance data
Role of Competent Authority & European Commission within Market Surveillance
Role of Competent Authority & European Commission within Market Surveillance
13 Topics
Section 9 Miscellaneous
Medical Device Coordination Group "Guidelines"
MDCG
Brexit
Brexit
Switzerland Mutual Recognition Agreement
Switzerland Mutual Recognition Agreement
Turkey & EFTA MDR 2017 745
Turkey & EFTA MDR 2017 745
Common Specifications
Common Specifications
The Rolling Plan
The Rolling Plan
1 Topic
Bonus Lecture
Medical Device Regulation 2017/745 EU regulatory affairs.
Related Medical Device Development Courses
Thank You!
Your review has been submitted successfully.