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Medical Device Regulation 2017/745 EU regulatory affairs.

Name: Medical Device Regulation 2017/745 EU regulatory affairs.
Rating: 4.4 (2061 reviews)

Understand regulations for medical devices in simple terms to gain market approval of a medical device in the EU.

Bestseller

Created byMartin Conneely

Last updated 12/2024

English

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.

Course content

10 sections • 53 lectures • 3h 54m total length

Section 1 Introduction0:40
Explain what is covered in section 1.0 Introduction
Introduction8:02
This lecture gives a summary introduction into the medical device regulation 2017 745
Why change?5:32
What are the learning objective in this lesson.
I will discuss an example of a case study from a French Medical device manufacturer called Poly Implant Prosthese (PIP).
I will examine how the consequences of this case study and others had an influence on changing the medical device regulation.
I will discuss other considerations that influenced change.
Why change?
Timelines7:02
Explain the transition timeline for the Medical Device Regulation 2017/745
Timelines for the introduction of the MDR 2017/745

Section 2 Economic Operators1:38
Explain what is covered in section 2 Economic Operators
Economic Operators3:42
We will understand who the economic operators are according to the MDR 2017/745.
We will understand how they correlate to one another.
Economic Operators
Economic Operator: The European Authorised Representative.4:51
Understand the role and responsibilities of the European Authorised Representative
Economic Operator: The European Authorised Representative.
Economic Operator: The Distributor4:22
Understand the definition of the distributor.
Understand the obligations of the distributor.
Economic Operator: The Distributor
Economic Operator: The importer6:02
Understand the role and responsibilities of the Importer.
Understand the definition of the importer.
Understand who audits the importer.
Economic Operator: The importer
Economic Operator: The manufacturer6:24
Explain the roles and responsibility of The manufacturer within the context of the medical device regulation 2017/745.
Economic Operator: The manufacturer
Economic Operator: Procedure pack & Systems Provider4:14
Understand the definition of the Procedure pack & System providers.
Understand the obligations of the Procedure pack & System providers
Procedure pack & systems
Economic Operator: Obligation change1:59
Understand when an economic operator obligation will change to that of a manufacturer
Economic Operator: Obligation change
Person Responsible for Regulatory Compliance6:59
•Understand the obligations of the Person Responsible for Regulation Compliance (PRRC)
•Understand the qualifications required to become a PRRC.
•Understand the responsibilities of the PRRC.
•Understand who is expected to have a PRRC.
•Understand when a PRRC can be hired in a consultant role.
Understand that a PRRC can carry out their work without been disadvantaged.
Person Responsible for Regulatory Compliance

Section 3 EUDAMED0:37
Explain what is covered in section 3 EUDAMED
EUDAMED Introduction3:39
What will we learn?
Understand what EUDAMED is.
Understand the 4 main functions of EUDAMED.
Understand the 6 modules associated with EUDAMED.
EUDAMED Actors registration5:25
Understand who the Actors are in the context of article 33.
Understand the single registration number. Which is also known as the SRN.
An example of a registration.
The validation process of an actor.
EUDAMED Actors registration
EUDAMED Timelines4:36
It will explain the timelines for the introduction of the Eudamed system.
EUDAMED Timelines

Section 4 UDI/Registration0:57
Explain what is covered in section 4 UDI/Registration
UDI Part 1 Introduction4:43
Where the UDI is primarily mentioned within the regulation.
What is the Unique Device Identification Database.
What is the Basic Unique Device Identifier.
UDI Part 1 Introduction
UDI Part 28:36
•Understand what the Unique Device Identification-Carrier is.
•Understand the AIDC “Automatic identification and data capture”
•Understand the HRI “Human Readable Interpretation “.
•How is the Unique Device Identifier created.
•Understand the Unique Device Identifier-Device Identifier.
•Understand the Unique Device Identifier-Production Identifier.
Companies accredited with creating Unique device identification carriers
UDI Part 2
UDI Part 37:12
•Understand who the current accredited organisations are that can create Unique Device identification carrier standards.
•An introduction to their standards.
•Their role and responsibility within the regulation.
UDI Part 3
UDI Timelines1:49
It will explain when the UDI carrier needs to be attached to the packaging and devices. In order to be compliant with the MDR 2017/745.
UDI Timelines

Section 5 Classification of medical devices0:35
Explain what is covered in section 5 Classification of medical devices
Classification of medical devices Introduction3:52
Introduction to the classification of medical devices
Classification of medical devices Introduction
Qualification of a medical device5:55
Medical device qualification.
Determine if we are making a medical device
Qualification of a medical device
Medical device definitions8:07
Understand medical device definitions. This will help the student how to classify a medical device.
Medical device definitions
Medical device classification rules3:59
Rules of medical device classification.
MDR Rules of Medical device classification
Apply Medical Device Rules9:25
We will identify some products and demonstrate how to classify them.
We will see how Guidance documents can help.
Apply Medical Device Rules

Section 6 Conformity assessment0:30
Explain what is covered in section 6 Conformity assessment
MDR Class I Conformity Assessment Route2:50
Conformity assessment path for a class I medical device
MDR Class I Conformity Assessment Route
MDR Class I r, Class I m, Class I r and Class II a conformity Assessment3:24
Explain the conformity assessment path for a class I s, I m & I r medical device.
MDR Class Ir, Class I m, Class r conformity assessment route
MDR Class II a conformity assessment route2:39
MDR Class II a conformity assessment route
MDR Class II a conformity assessment route.
MDR Class II b conformity assessment route3:09
MDR Class II b conformity assessment route
MDR Class II b conformity assessment route
MDR Class III conformity assessment route3:07
The learner will understand the conformity assessment route for a class III medical device.
MDR Class III conformity assessment route

Section 7 Sufficient Clinical Data0:56
Understand sufficient clinical data in the context of pre market approval.
General safety and performance requirement10:57
The learner will understand what the General Safety and Performance Requirements mean regarding compliance to the MDR 2017/745.
General safety and performance requirement
Intended Purpose7:23
What the intended purpose is and how this is broken up into certain sections
Intended Purpose
Sufficient Clinical Data. Clinical Evaluation4:23
Sufficient clinical Data. Clinical Evaluation.
What clinical evaluation is.
When clinical evaluation is undertaken.
Why is clinical evaluation important.
What Equivalence is.
Sufficient Clinical Data. Clinical Evaluation
Sufficient clinical Data. Post market clinical follow up.5:53
Sufficient clinical Data. Post Market Clinical Follow up (PMCF).
Why need post market clinical follow up.
Post Market Clinical Follow up plan.
Method of collecting data.
Sufficient clinical Data. Post market clinical follow up.

Section 8 Post Market Surveillance0:54
Explain what section 8 consists of
Post market surveillance system & plan.8:14
What does the regulation call out for regarding Post Market Surveillance.
What a post market surveillance system should comprise of.
How will the data be utilized that is gathered from the post market surveillance system.
What will a manufacturer do with that data.
What is a PMS plan.
Post market surveillance system & plan.
Post market surveillance report and Periodic safety update report4:38
What will we learn.
We will understand what a post market surveillance report is.
We will understand what a Periodic safety update report is.
Post market surveillance report and Periodic safety update report
Vigilance system7:03
Understand the Post Market Vigilance system for the MDR 2017/745.
Vigilance system
Analysis of vigilance data3:42
What will we learn.
We will understand what is meant by reporting of serious incidents and field safety corrective actions.
We need to understand that we are now in the realm of being reactive. What does this mean. The manufacturer is reaction to signals of the device in the market place.
Analysis of vigilance data
Role of Competent Authority & European Commission within Market Surveillance9:42
What will we learn.
We will understand what is meant by Market Surveillance and go into detail in section 3 of chapter VII. This is the 3rd section of chapter 7 of post market surveillance we need to consider. It focuses on the role and responsibility of the competent authority and the commission regarding post market surveillance
Role of Competent Authority & European Commission within Market Surveillance

Section 9 Miscellaneous0:42
Extra items to be discussed
Medical Device Coordination Group.
Brexit.
Switzerland.
EFTA.
Common Specifications.
The EC Rolling plan.
Medical Device Coordination Group "Guidelines"5:08
Explain the role of the Medical device coordination group.
MDCG
Brexit5:01
Understand how Brexit will affect medical device regulation in the UK and the European Union
Brexit
Switzerland Mutual Recognition Agreement3:49
•Understand the Mutual Recognition Agreement between Switzerland and the EU,
•What is the current status of the MRA.
•How does this affect the MDR 2017/745 in Switzerland.
Switzerland Mutual Recognition Agreement
Turkey EEA EFTA MDR3:55
Understand how Turkey and the EFTA will transition to the MDR 2017 745.
Turkey & EFTA MDR 2017 745
Common Specifications2:27
Understand what is meant by Common Specification in the context of the MDR 2017 745.
Common Specifications
The Rolling Plan1:26
We will understand what the rolling plan is.
The Rolling Plan

Bonus Lecture1:55
Please find a PDF which explains other courses that you can obtain which I have created. The courses are:
"Quality Control 7 Basic Tools. Basic lean improvement tools".
"European Medical Device regulation explained in simple terms".
"Medical Device Process Validation explained in simple terms"
In the resource section one can find:
List of abbreviations.
MDR Actor Module frequently asked questions.
Basic UDI DI guidance.
Competent authority frequently asked questions regarding the MDR 2017 745.
Medical device directive 90-385-EEC.
Medical device directive 93-42-EEC.
Guidance document on creation of UDI for systems pack providers.
Step by step guidance when to report an adverse event.
MDR 2017 745 road map from the competent authorities.
MDCG guidance on registering legacy devices in EUDAMED.
Medical device guidance document list.
Medical device manufacturers fact sheet to prepare for MDR 2017 745.
International Medical Device Regulatory Forum (IMDRF) guidance on UDI.
UDI label samples.
MDCG 2020-06 guidance on sufficient clinical data on legacy devices.
Global Harmonization Taskforce guidance on compliance audits of Quality Management Systems.
MDCG 2020-13 guidance on clinical evaluation reporting template.
Additional guidance on vigilance
MDCG 2019-9 guidance on summary of safety and clinical performance.
Guidance on Post market clinical follow up.
Guidance notes on medical devices class 1.
Q&A on manufacturers incident report forms.
European National Competent authority list.
These can be used as reference material and can help you on your journey to medical device compliance within the European Union.

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

Medical Device Regulation 2017/745 EU regulatory affairs.

What you'll learn

Explore related topics

Course content

Section 1 Introduction4 lectures • 21min

Section 2 Economic Operators9 lectures • 40min

Section 3 EUDAMED4 lectures • 14min

Section 4 UDI/Registration5 lectures • 23min

Section 5 Classification of medical devices6 lectures • 32min

Section 6 Conformity assessment6 lectures • 16min

Section 7 Sufficient Clinical Data5 lectures • 30min

Section 8 Post market Surveillance6 lectures • 34min

Section 9 Miscellaneous7 lectures • 22min

Bonus Section1 lecture • 2min

Requirements

Description

Who this course is for: