Quy định về Thiết bị Y tế 2017/745 và các vấn đề quản lý tuân thủ tại EU.

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.