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 bite size 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 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
Please Note:
If you have any specific questions after the fundamentals training, contact us on [email protected] and we will invite you to one of our free one-hour lunchtime consultations with an expert.