Medical Device Regulation 2017/745 EU regulatory affairs.
- Descrição
- Currículo
- FAQ
- Revisões
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.
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1
Section 1 IntroductionExplain what is covered in section 1.0 Introduction
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2
Introduction
This lecture gives a summary introduction into the medical device regulation 2017 745
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3
Why change?
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.
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4
Why change?Understand lecture 2 "why change" in detail.
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5
Timelines
Explain the transition timeline for the Medical Device Regulation 2017/745
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6
Timelines for the introduction of the MDR 2017/745
Understand when the Medical device regulation 2017/745 becomes mandatory in the European Union.
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7
Section 2 Economic Operators
Explain what is covered in section 2 Economic Operators
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8
Economic Operators
We will understand who the economic operators are according to the MDR 2017/745.
We will understand how they correlate to one another.
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9
Economic Operators
Understand who the Economic Operators are?
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10
Economic Operator: The European Authorised Representative.
Understand the role and responsibilities of the European Authorised Representative
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11
Economic Operator: The European Authorised Representative.
Understand the obligation of the European Authorised Representative and its role
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12
Economic Operator: The Distributor
Understand the definition of the distributor.
Understand the obligations of the distributor.
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13
Economic Operator: The Distributor
Understand the obligation of the Distributor in the context of the economic operator.
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14
Economic Operator: The importer
Understand the role and responsibilities of the Importer.
Understand the definition of the importer.
Understand who audits the importer.
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15
Economic Operator: The importer
Understand the obligation of the Importer in the context of the medical device regulation.
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16
Economic Operator: The manufacturer
Explain the roles and responsibility of The manufacturer within the context of the medical device regulation 2017/745.
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17
Economic Operator: The manufacturer
Understand the obligation of the manufacturer has within the context of the medical device regulation.
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18
Economic Operator: Procedure pack & Systems Provider
Understand the definition of the Procedure pack & System providers.
Understand the obligations of the Procedure pack & System providers
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Procedure pack & systems
Understand the obligations of the procedure pack and systems have within the context of the medical device regulation 2017 745.
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20
Economic Operator: Obligation change
Understand when an economic operator obligation will change to that of a manufacturer
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21
Economic Operator: Obligation change
Understand when an economic obligation will change.
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22
Person Responsible for Regulatory Compliance
•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.
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23
Person Responsible for Regulatory Compliance
Understand what the obligation is of the PRRC. Person responsible for regulatory compliance.
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24
Section 3 EUDAMED
Explain what is covered in section 3 EUDAMED
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25
EUDAMED Introduction
What will we learn?
Understand what EUDAMED is.
Understand the 4 main functions of EUDAMED.
Understand the 6 modules associated with EUDAMED.
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EUDAMED Actors registration
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.
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EUDAMED Actors registration
Understand who the Actors are within EUDAMED.
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EUDAMED Timelines
It will explain the timelines for the introduction of the Eudamed system.
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EUDAMED Timelines
Understand when each Module within the EUDAMED base will come on line.
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30
Section 4 UDI/Registration
Explain what is covered in section 4 UDI/Registration
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31
UDI Part 1 Introduction
Where the UDI is primarily mentioned within the regulation.
What is the Unique Device Identification Database.
What is the Basic Unique Device Identifier.
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32
UDI Part 1 Introduction
Introduction to what the Unique Device Identification is
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33
UDI Part 2
•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
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34
UDI Part 2
Understand how to read the unique device identification carrier in detail.
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35
UDI Part 3
•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.
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36
UDI Part 3
Understand the current four accredited organisations which create Unique Identification carriers in the European Union.
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37
UDI Timelines
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.
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38
UDI Timelines
Understand when the medical device regulation mandates an UDI needs to be applied to the packaging of a device.
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39
Section 5 Classification of medical devices
Explain what is covered in section 5 Classification of medical devices
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40
Classification of medical devices Introduction
Introduction to the classification of medical devices
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41
Classification of medical devices Introduction
An introduction on the classification of a medical device as mandated by the medical device regulation.
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42
Qualification of a medical device
Medical device qualification.
Determine if we are making a medical device
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43
Qualification of a medical device
Understand how the manufacturer determines if they are making a medical device or not. We call this qualification.
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44
Medical device definitions
Understand medical device definitions. This will help the student how to classify a medical device.
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45
Medical device definitions
This will quiz will help the learner to understand the definitions of a medical device. This will help the learner to understand how to classify a medical device.
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46
Medical device classification rules
Rules of medical device classification.
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47
MDR Rules of Medical device classification
Understand how the rule work regarding medical device classification
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Apply Medical Device Rules
We will identify some products and demonstrate how to classify them.
We will see how Guidance documents can help.
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Apply Medical Device Rules
Understand how to apply the medical device classification rules.
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50
Section 6 Conformity assessment
Explain what is covered in section 6 Conformity assessment
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51
MDR Class I Conformity Assessment Route
Conformity assessment path for a class I medical device
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52
MDR Class I Conformity Assessment Route
Understand the conformity assessment route for class I medical devices.
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53
MDR Class I r, Class I m, Class I r and Class II a conformity Assessment
Explain the conformity assessment path for a class I s, I m & I r medical device.
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54
MDR Class Ir, Class I m, Class r conformity assessment route
Understand the assessment route that must be taken for Class I r, Class I m and Class I s medical devices.
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55
MDR Class II a conformity assessment route
MDR Class II a conformity assessment route
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56
MDR Class II a conformity assessment route.
Understand the assessment route a class II a medical device must conform to.
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57
MDR Class II b conformity assessment route
MDR Class II b conformity assessment route
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MDR Class II b conformity assessment route
Understand the conformity assessment route which needs to be take by the MDR class II b.
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59
MDR Class III conformity assessment route
The learner will understand the conformity assessment route for a class III medical device.
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60
MDR Class III conformity assessment route
Understand the conformity assessment route for a class III medical device.
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61
Section 7 Sufficient Clinical Data
Understand sufficient clinical data in the context of pre market approval.
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General safety and performance requirement
The learner will understand what the General Safety and Performance Requirements mean regarding compliance to the MDR 2017/745.
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63
General safety and performance requirement
Understand what the General safety and performance requirements are.
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64
Intended Purpose
What the intended purpose is and how this is broken up into certain sections
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Intended Purpose
Understand what is meant by intended purpose and how it is important to medical device compliance.
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Sufficient Clinical Data. Clinical Evaluation
Sufficient clinical Data. Clinical Evaluation.
What clinical evaluation is.
When clinical evaluation is undertaken.
Why is clinical evaluation important.
What Equivalence is.
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Sufficient Clinical Data. Clinical Evaluation
Will help the learner to understand what clinical evaluation means.
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Sufficient clinical Data. Post market clinical follow up.
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.
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69
Sufficient clinical Data. Post market clinical follow up.
The learner will understand what Post market clinical follow up is.
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70
Section 8 Post Market Surveillance
Explain what section 8 consists of
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Post market surveillance system & plan.
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.
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Post market surveillance system & plan.
The learner will understand what is meant by a Post market surveillance system and plan.
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Post market surveillance report and Periodic safety update report
What will we learn.
We will understand what a post market surveillance report is.
We will understand what a Periodic safety update report is.
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Post market surveillance report and Periodic safety update report
Understand Post market surveillance report and periodic safety update report.
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Vigilance system
Understand the Post Market Vigilance system for the MDR 2017/745.
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Vigilance system
The learner will understand the vigilance system
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Analysis of vigilance data
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.
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Analysis of vigilance data
The learner will understand the analysis of vigilance data.
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Role of Competent Authority & European Commission within Market Surveillance
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
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80
Role of Competent Authority & European Commission within Market Surveillance
Understand the role of the competent Authority & European Commission within Market Surveillance
