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
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.
