Since the inception of the EU Medical Device Regulations, selling Medical devices in Europe has become a topical discussion with much debate and discretion, manufacturers selling Medical Devices in Europe have been encouraged by the EU Parliament to continue implementing the EU MDR and transitioning from the Medical Device Directive. In this course, you shall learn what is required to implement the EU MDR using the appropriate articles and annexes from the regulation.
In this course, you will learn:
Course Duration: 0.5 to 2 days
Module 1: Introduction to EU Medical Device Regulations & Implementing a QMS according to EU MDR Regulations & What you need to change in your QMS to Article 120
The differences between Medical Device Directives and the Medical Device Regulations. What you need to do in your Regulatory Strategy. What Articles and Annexes to quote and in which procedures within your ISO 13485 QMS?
Module 2: What you need to do according to Article 10a Obligations of Manufacturers
In this part, we discuss as a legal manufacturer what obligations you must fulfil according to the EU MDR.
Module 3: According to Articles 61- 66 Clinical Evaluation and Annex XIV
Clinical Evaluations are known to be a big area of contention, so making equivalence is not so easy. What do you need to do to ensure your device conforms to the EU MDR requirements for equivalency and what you can do to avoid performing Clinical Investigations and remaining compliant? We will also discuss Clinical Investigations should you not be able to claim equivalence according to ISO 14155.
Module 4: Your Test strategy to validate your device
We will discuss the intended Use Statement, User Requirements, Design Inputs, Outputs and Testing Verification and Validation to demonstrate a trace of the design. This includes the Design Development Plan, Design Review meetings and Design Freeze.
Module 5: Creation of a Technical File to Annex II
We will talk you through the creation of a CE Technical File according to the requirements of Annex II of the EU MDR 2017/745. This part includes what to write in your Declaration of Conformity and also how to write your GSPRs to Annex I.
Module 6: What you need to do as a Class I, IIa, IIb and Class III Medical Device.
Writing a Technical File is challenging but even more so if the Classification of your device is a Class IIb or Class III, in this lesson we shall discuss what you need before submitting a Technical File to a Notified Body and then what to expect from your audit.
Module 7: EUDAMED and Authorised Representative and Economic Operators & Post Market Surveillance, and Periodic Safety Update Report.
We shall discuss your responsibility as an actor according to EU law and the EUDAMED database as well as appointing an Authorised Representative. We shall also look at PMS activities. We will also look at the role of Economic Operators, that is the Manufacturer, Importer and Distributor in addition to the Authorised Representative.
The benefit of this course is that you will be more confident about the entire process of CE marking a Medical Device to commercialise your device in the EU market. Having a CE marked device opens up doors in other territories in addition to EU.
In this course, you will learn:
ISO 13485 – EU MDR – EU IVDR – CLINICAL EVALUATION – PROCESS VALIDATION – DIGITAL HEALTH – RISK MANAGMENT
