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MDR Fundamentals e-learning 

This is a self directed, self paced E-learning course.  You can pause the training and repeat sections it as many times as you wish.  Option A: €599 bought as a stand alone course.  Option B: €299 when you also book Any other IQC course.  Need a quote for In-house Training? email us today info@iqc.ie  NOTE: there are 16 modules in this training course. You can complete the modules in any order you like. 

 

Introduction 
 
The legislation outlining the requirements for the medical device market in the European Union is changing. 
 
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC 
 
The new Medical Device regulations place greater emphasis on accountability for all players and with greater scrutiny of both clinical evaluation and post- market clinical evaluations and improved traceability of devices for the full life cycle. 
 
It is essential that personnel involved in the Medical Device Industry understand the core fundamentals behind the MDR Regulation. 
 
This online training is designed to allow you break down the MDR regulation into 16 bitesize chunks and (at your own pace), build and enhance your existing knowledge. 
 
We recommend delegates undertaking the E-Learning then attend the more advanced MDR workshop where specifics can be further discussed and explained by a tutor. 
 
Who should do this course? 
This training is useful for all staff in Medical Device and from all levels within the organization, to help them understand how compliance with the new MDR can be achieved. 
 
Operational Staff 
Quality personnel 
Authorised Rep 
Management and Supervisors 
Economic Operators 
 
Any personnel involved in the design, development, implementation and auditing of quality management systems 
 
This course is only suitable to those working in the Medical Device industry who are currently or have future plans to work in the industry. 
 
 
 
Course Objectives: 
This 16 Modules course on MDR is learner/self paced 
By the end of the course participants will have gained better knowledge on the following: 
MDR - History and purpose of the regulation. 
Structure of the EU-MDR. 
Terminology used throughout the regulation. 
Key changes introduced by the EU-MDR and the timelines for transition. 
Types of device that are covered by the regulation. 
Devices that do not have an intended medical purpose but are covered by the EU-MDR. 
Classes of medical device according to the EU-MDR 
Rules that are used to classify a device based on intended use 
Conformity routes 
Obligations of the economic operators and the Person Responsible for 
Regulatory Compliance (PRRC). 
Claims about the device, the use of harmonised standards and common specifications. 
Responsibilities: Manufacturers, Authorised Representatives, Importers and distributors. 
Requirements set out for the implant card, single use devices, Declaration of 
Conformity and the CE marking of conformity. 
Requirements for devices with special purposes, systems & procedure packs, parts & components and free movement. 
General Safety and Performance Requirements. 
Establishing the Technical documentation. 
Requirements for post-market surveillance and vigilance. 
Difference between proactive and reactive post-market surveillance. 
Clinical evaluation and clinical investigation requirements. 
Clinical evaluation process and the equivalence criteria. 
Post-Market Clinical Follow- Up plan and report, and the purpose and contents of the 
Summary of Safety and Clinical Performance. 
UDI barcode. 
Timelines for applying a UDI number to each class of device. 
EUDAMED and the application of its seven sub-databases. 
You can complete the 16 modules in any order and as many times as you like. 
Module Title 
Introduction 
QMS and PPRC 
Economic Operators and MAID 
General Safety and Performance 
Material Compliance 
Labelling 
UDI 
IFU 
EUDAMED 
Device Classification 
Non Medical Device Products in Scope of MDR 
Validity of Conformity Assessment & Certification 
Content Requirements for Technical Documents 
Clinical Evidence and Evaluation 
Submissions 
Post Market Surveillance and Vigilance 
ISO MDR Fundamentals e-learning
€599.00

This online training is designed specifically for those who are new to ISO 9001, or are scheduled to attend our IRCA Approved Internal / Lead Auditor training courses.

If you are purchasing the course on behalf of a colleague please fill in the details below so we can email important course material. If there are additional attendees please add their details in the Additional Attendee section at checkout.

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ISO 9001 Fundamental E-Learning:
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This option is only available if you also book in for the Internal Auditors course. 
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