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IVDR 2017 746 regulatory affairs: Learn EU compliance

Name: IVDR 2017 746 regulatory affairs: Learn EU compliance
Rating: 4.4 (332 reviews)

Understand regulations for Invitro diagnostic medical devices in simple terms to gain EU market approval

Created byMartin Conneely

Last updated 12/2024

English

What you'll learn

Understand European Union regulatory affairs for marketing an in vitro diagnostic medical device in the EU.
Why was there a change from the directive to the IVDR 2017 746?
The timelines for the transition of the IVDR 2017 746.
Economic Operators and their obligations. European Authorised Representative, Distributor, Importer and Manufacturer.
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 an in vitro diagnostic medical device with examples, quizzes and guidance documents.
The student will learn how to choose a conformity assessment route for each particular classification of an in vitro diagnostic 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 IVDR 2017/746.
Understand how Switzerland, Turkey and the EFTA are affected by the IVDR 2017/746.
Understand what the EU commission rolling plan is.
Understand how the European Union Reference laboratories will support the implementation of the IVDR 2017 746

Course content

11 sections • 57 lectures • 6h 33m total length

Section 1.0 Introduction0:47
Understand what the student will learn in section 1.0 Introduction
Introduction to the regulation11:10
What are the learning objective.
You will understand the transition from the medical device directives to the medical device regulation.
What will the changes bring.
What does the medical device regulation contain.
I will give a quick summary of the chapters and the annexes. I want students to understand that this is a brief summary of the Medical device regulation. The module will explain the principles of the regulation in further detail
Introduction to the regulation
Challenges11:26
•Understand the challenges associated with the transition to the In vitro diagnostics regulation 2017/746
Challenges
What is an In Vitro diagnostic Medical device10:17
Understand in simple terms what an In Vitro diagnostic medical device is.
What is a In Vitro diagnostic Medical device
Why change?10:52
Understand a case study to examine why medical device marketing European Legislation changed.
Why change?

Section 2.0 Economic Operators0:40
Understand what the student will learn in section 2.0 Economic Operators.
Economic Operators9:03
•Who are the economic operators?
•Obligation of economic operator.
•Responsibilities within the supply chain.
Economic Operators
Economic Operator: The European Authorised Representative.7:25
•Understand the definition of the authorised representative.
•Understand the obligations of the authorised representative.
Economic Operator: The European Authorised Representative.
Economic Operator: The Distributor5:05
•Understand the definition of the distributor.
•Understand the obligations of the distributor.
Economic Operator: The Distributor
Economic Operator: The importer9:43
•We will understand the role and responsibilities of the Importer.
•We will understand the definition of the importer.
•We will understand who audits the importer.
Economic Operator: The importer
Economic Operator: The manufacturer8:22
We will understand the definition of the manufacturer.
We will Understand the obligations of the manufacturer.
Economic Operator: The manufacturer
Economic Operator: Obligation change2:42
•We will understand when an economic operator obligation will change to that of a manufacturer.
Economic Operator: Obligation change
Person Responsible for Regulatory Compliance9:47
•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 3.0 EUDAMED0:20
Understand what the student will cover in section 3.0 EUDAMED
EUDAMED: Introduction5:10
EUDAMED Actors registration7:56
•Understand who the Actors are.
•Understand the single registration number.
•An example of a registration.
•The validation process of an actor.
EUDAMED Actors registration
EUDAMED Timelines5:05
We will understand the timelines associated with the implementation of EUDAMED.
EUDAMED Timelines

Section 4.0 UDI/Registration0:33
Understand what is covered in this section
UDI: Introduction9:10
What will we learn?
We will understand where the UDI is primarily mentioned within the regulation.
We will understand what is the Unique Device Identification Database.
We will learn what a Basic Unique Device Identifier is.
UDI: Introduction
UDI: The Carrier13:58
What will we learn?
How is the Unique Device Identification created.
Understand the Unique Device Identification-Carrier. What is the system used to create the code.
Understand the AIDC “Automatic identification and data capture”. The machine readable part of the identification code.
Understand the HRI “Human Readable Interpretation “. The readable part of the code.
Understand the Unique Device Identification-Device Identifier. Which is called the UDI-DI.
Understand the Unique Device Identification-Production Identifier. Which is called UDI-PI.
Companies accredited with creating Unique device identification carriers. Which companies have been approved by the EU commission to create the Carrier ID.
UDI: The Carrier
UDI: Accredited Organisation10:25
•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: Accredited Organisation
UDI: Timelines3:55
Understand when the UDI needs to be inputted into the EUDAMED data base.
Understand the timelines for labelling in vitro diagnostic medical devices with the UDI.
UDI: Timelines

Section 5.0 Classification of an in vitro diagnostic medical device0:48
We will understand what is covered in section 5.0
Qualification of an invitro diagnostic medical device12:33
•Understand in simple terms what an In Vitro diagnostic medical device is.
•Look at some examples.
•Understand the principle of qualification, classification and conformity assessment.
Qualification of an invitro diagnostic medical device
Classification of In Vitro diagnostic medical devices5:11
Understand what is meant by classification.
We will understand some examples to illustrate the classification.
Classification of an In Vitro diagnostic medical device
Definitions as per the MDCG 2020-1615:39
We will understand the definitions that will help us to classify an in vitro diagnostic medical devices into their classification's levels.
Definitions as per the MDCG 2020-16
Application of In vitro diagnostic medical device rules part 1.5:19
What will we learn?
We will understand what is meant by the intended purpose of an in vitro diagnostic medical device.
We will understand what is meant by the Implementing rules within the context of the regulation.
We will briefly look at the 7 rules which helps the manufacturer classify their in vitro diagnostic medical device.
Applying Classification Rules Part 1
Application of In vitro diagnostic medical device rules part 2.2:18
What will we learn?
We will take an example of an in vitro diagnostic medical device and go through the rules to classify this device. Our example in this case will be a syphilis test.
Applying classification rules part 2
Application of In vitro diagnostic medical device rules part 331:01
What will we learn?
We will take an example of an in vitro diagnostic medical device and go through the rules to classify this device. Our example in this case will be a Non-typhoidal anti-salmonella antibodies.
We will understand the 7 rules for classification of an invitro diagnostic medical device.
We are going to go through all the rules in this lecture, so the time of the lecturer will be a little longer that usual, but hang in there, it will be beneficial
Applying classification rules part 3
Application of In vitro diagnostic medical device rules part 42:49
What will we learn?
We will understand how to classify a SARs-CoV-2 Rapid antigen test.
Applying Classification Rules Part 4
Application of In vitro diagnostic medical device rules part 59:36
What will we learn?
We learn where software qualification and classification fits into the puzzle.
Applying classification rules Part 5

Conformity Assessment Route0:21
We will discuss what is covered in section 6.0
Conformity Assessment route class A in vitro diagnostic medical device7:12
What will we learn?
What is the conformity assessment route for a class A in vitro diagnostic medical device.
What is the conformity assessment route for a class A sterile in vitro diagnostic medical device.
Conformity Assessment route class A in vitro diagnostic medical device
Conformity Assessment Route class B in vitro diagnostic medical devices7:36
What will we learn?
What is the conformity assessment route for a class B in vitro diagnostic medical device.
What is the conformity assessment route for a class B in vitro diagnostic medical device for near patient testing NPT and self testing.
Conformity Assessment Route class B in vitro diagnostic medical devices
Conformity Assessment Route class C in vitro diagnostic medical devices13:20
What will we learn?
What is the conformity assessment route for a class C in vitro diagnostic medical device. In this context we are excluding devices that are used for near patient testing NPT and self testing.

What is the conformity assessment route for a class C in vitro diagnostic medical device for near patient testing NPT and self testing.

What is the Conformity assessment route for a class C device which is a companion diagnostic (CDx)
Conformity Assessment Route class C in vitro diagnostic medical devices
Conformity Assessment Route class D in vitro diagnostic medical devices11:47
What will we learn?
What is a Common specification.
What is EU Reference Laboratories.
What is the conformity assessment route for a Class D in vitro diagnostic medical device (excluding CDx), with Common Specification.
What is the conformity assessment route for a class D in vitro diagnostic medical device(excluding CDx), with no Common Specification.
What is the conformity assessment route for a class D in vitro diagnostic medical device Companion Diagnostic.
Conformity Assessment Route class D in vitro diagnostic medical devices

Section 7.0 Sufficient Clinical Evidence0:47
Explain what is contained within section 7.0
General Safety and Performance Requirements10:41
What will we learn?
Understand Annex I which is the general safety and performance requirements that the regulation mandates of a medical device.
Understand chapter 1 – General requirements.
Understand Chapter 2 – Performance, Design and manufacturing.
Understand Chapter 3 – Labels and Instruction for Use.
Understand how standards support the GSPR.
General Safety and performance requirements
The Intended Purpose8:03
What will we learn?
What the intended purpose is and how this is broken up into certain sections
The Intended patient population.
The medical indication.
The user.
How to use the device.
How to create the claims.
Risk vs Benefit.
The Intended Purpose
Clinical Evaluation10:07
What will we learn?
What clinical evaluation is.
When clinical evaluation is undertaken.
Why is clinical evaluation important.
What is performance evaluation
What Equivalence is.
Clinical Evaluation
Post Market Performance Follow Up.7:45
What will we learn?
Why the manufacturer needs a post market performance follow up.
Post Market Clinical Follow up plan.
Method of collecting data.
Post Market Performance Follow Up.

Section 8.0 Post Market Surveillance0:59
We will understand what we will learn in Section 8 of Post Market Surveillance
Post Market System & Plan.10:17
What will we learn?
•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 System & Plan
Post Market Surveillance Plan & Periodic Safety Update Report5:35
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.
Vigilance7:25
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.
Vigilance Quiz
Analysis of Vigilance data6:24
What will we learn?
We will understand what is meant by Analysis of serious incidents and field safety corrective actions.
This is covered under article 84 which is contained in Chapter VII under vigilance section 2.
We will also examine article 85 which is the analysis of vigilance data.
Analysis of Vigilance Data
Post Market Surveillance: Role of Competent Authority10:21
What will we learn?
•Market surveillance
•Role and responsibility of the competent authority
•Role and responsibility of the commission.
Post Market Surveillance: Role of Competent Authority

Section 9.0 Miscellaneous1:24
We will explain what is in section 9.0 Miscellaneous
Brexit6:59
What will we learn?
What is the impact of the UK leaving the EU. (Brexit)
Brexit
Medical Device Coordination Group6:30
What will we learn.
We will understand what is meant by the medical device coordination group.
Medical Device Coordination Group
Common specification3:07
What will we learn?
Understand common specification within the context of the IVDR
Common Specification
Switzerland Mutual Recognition Agreement5:10
What will we learn.
Understand the Mutual Recognition Agreement between Switzerland and the EU,
What is the current status of the MRA.
How does this affect the IVDR 2017/746 in Switzerland.
Switzerland Mutual Recognition Agreement
Turkey Association Agreement EEA Mutual Agreement3:33
What will we learn.
Understand the association agreement with Turkey and the EU.
Understand the bilateral agreements with the EFTA.
How does this affect the IVDR 2017/746 Turkey and the EFTA.
Turkey & Association Agreement EEA Mutual Agreement
The Rolling plan1:32
What will we learn?
We will understand what the rolling plan is.
The Rolling Plan. The European commissions road map for the implementation of the IVDR 2017 746.
The Rolling plan
European Union Reference Laboratories4:49
What will we learn.
We will understand what the European Union Reference Laboratories are.
We will understand what the National Reference Laboratories are.
We will understand how the EURL network supports the IVDR.
We will understand the tasks of the EURL.
European Union Reference Laboratories

Requirements

A desire to understand in vitro diagnostic medical device regulation in simple terms. Understand regulatory affairs in the medical device industry.

Description

This Course is broken into nine sections. The objective of the course is to explain the in vitro diagnostic medical device regulation 2017/746 in simple terms:

Section 1 Introduction.

Introduction to the in vitro diagnostic medical device regulation 2017 746.

Why was there a change from the directive to the IVDR 2017 746?

The timelines for the transition of the IVDR 2017 746.

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.

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. What is it? Why is it needed?

UDI The Carrier. Understand the unique device identification carrier.

UDI Accredited Organisation. 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 in vitro diagnostic medical devices

Qualification of in vitro diagnostic medical devices. Determine if the manufacturer is making a medical device.

Classification of in vitro diagnostic medical devices Introduction.

Understand in vitro diagnostic medical device definitions. This will help the student how to classify a medical device.

Rules of in vitro diagnostic medical device classification. Understand the implementation of the rules.

IVDR apply in vitro diagnostic medical device rules.

Section 6 Conformity assessment

Explain the Conformity assessment path for Class A in vitro diagnostic medical devices. Explain the Conformity assessment path for Class B in vitro diagnostic medical devices. Explain the Conformity assessment path for Class C in vitro diagnostic medical devices. Explain the Conformity assessment path for Class D in vitro diagnostic medical devices.

Section 7 Sufficient Clinical data

The General Safety and Performance Requirements.

The Intended purpose.

Sufficient clinical Data. Clinical Evaluation.

Post Market Performance Follow up (PMPF).

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

Switzerland Mutual Recognition Agreement

Turkey and EFTA agreement with the EU.

Common Specifications

The Rolling plan.

European Union Reference Laboratories

The benefits of the course will be:

Save you time.

Really understand regulation in simple terms.

Help you prioritizes work to prepare for the IVDR 2017 746 timelines.

Understand why regulation was introduced.

Know your obligation to the IVDR 2017 746.

Know the obligation to EUDAMED and the timelines.

Examples of how Unique Device Identification carriers are created.

Worked examples how in vitro diagnostic medical devices are classified.

Know the conformity assessment route to take for each in vitro diagnostic medical device.

Know what sufficient clinical data to collect to be compliant.

Understand the market surveillance requirements to allow the in vitro diagnostic medical device to stay in the marketplace.

Understand the UK and EU manufacturers responsibility post Brexit.

Understand Turkey and the EFTA (Switzerland, Liechtenstein, Norway, and Iceland) manufacturers responsibility regarding the IVDR 2017 746.

Understand how the European Union Reference laboratories support the implementation of the IVDR.

Who this course is for:

Medical Device Engineers
In vitro diagnostic medical device engineers
Quality control within the medical device & in vitro diagnostic medical device industry
Operation Managers within the in vitro diagnostic medical device & the medical device industry
Entrepreneurs or small medium start-up companies that need to develop a new in vitro diagnostic medical device.
Quality Control Technicians
Process Engineers
Regulatory Affairs.
Marketing within the in vitro diagnostic medical device industry
Research and Development Engineers within the in vitro diagnostic 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 in vitro diagnostic medical device Industry
In vitro diagnostic 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 in vitro diagnostic medical device industry
Process and Development Engineers.
People managers within the In vitro diagnostic medical device and health care industry.
Manufacturing Engineers.
Students who need to really understand the in vitro diagnostic medical device regulation 2017 746 in simple terms.
Health care providers. (Doctors and Nurses for example)
Professionals involved in pre clinical in vitro diagnostic medical devices studies
Professionals involved in clinical trials of in vitro diagnostic medical devices.
Professionals involved in Post market surveillance of in vitro diagnostic medical devices.
Economic Operator The manufacturer.
Economic Operator The distributor.
Economic Operator The European Authorised Representative.
Economic Operator The Importer.

IVDR 2017 746 regulatory affairs: Learn EU compliance

What you'll learn

Explore related topics

Course content

Section 1.0 Introduction5 lectures • 45min

Section 2 Economic Operators8 lectures • 53min

Section 3.0 EUDAMED4 lectures • 19min

Section 4.0 UDI/Registration5 lectures • 38min

Section 5.0 Classification of an In Vitro diagnostic medical device9 lectures • 1hr 25min

Section 6.0 Conformity Assessment5 lectures • 40min

Section 7.0 Sufficient Clinical Evidence5 lectures • 37min

Section 8.0 Post Market Surveillance6 lectures • 41min

Section 9.0 Miscellaneous8 lectures • 33min

Extra Content1 lecture • 1min

Requirements

Description

Who this course is for: