MDR Fundamentals e-learning
This is a self-directed, self-paced E-learning course. You can pause the training and repeat sections as many times as you wish. Cost €399. Access is available for 30 days. Need a quote for In-house Training? email us today info@iqc.ie NOTE: there are 15 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 within the Medical Device 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 devices 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