PT219: MD-QMS Comprehensive EU Medical Device Regulation 2017/745 (EU-MDR) Practitioner 2.5 Days Course ID: 2426 Virtual Training 8 Delegates Maximum per training
(Mar 6 and 7 full days and Mar 8 half day) ATP Number:11800057 IRCA and Exemplar Global Certified Course
€995 Price includes* training, all training materials, certification and refreshments during the training where applicable. (*there are no hidden fees at IQC) Need a quote for In-house Training email us today email@example.com Please note that participants attending the MDR course are expected to have prior knowledge of quality management principles and concepts, and the basic requirements of the existing Medical Device Directives. IQC will provide a “Pre-course” pack to all delegates approximately 7 days before the training commences to help you refresh.
The legislation outlining the requirements for medical device manufacturers prior to placing them on the market in the European Union is changing.
The old Medical Devices Regulation (EU 2017/745) is to be replace the Medical Devices Directive (93/42/EEC). The new 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.
Who should attend this workshop?
This training is aimed at those with a working knowledge of a Medical Device QMS from all levels within the organisation including (but not limited to):
• Authorised Representatives
• Manufacturing personnel
• Regulatory Affairs
• Design and Development
• Economic Operators for example importers and distributors
Places cancelled within 10 working days of commencement must be paid in full. Substitutions may be made at any time at no additional charge.
The 2.5 day course on MDR is highly interactive with many team exercises and discussion to give learners a good foundation in the complex and detailed new regulation. Learners will build and enhance their existing knowledge in relation to the new MDR, its implementation and the complexities surrounding the Newly structured Notificed Bodies.
Please Note: that participants attending the MDR course are expected to have prior knowledge of quality management principles and concepts, and the basic requirements of the existing Medical Device Directives.
By the end of the course participants will be able to:
1) Explain the history and purpose of the regulation.
2) Outline the structure of the EU-MDR.
3) Define the key terminology used throughout the regulation.
4) Explain the key changes introduced by the EU-MDR and the timelines for transition.
5) Explain what a medical device is and describe the types of device that are covered by the regulation.
6) Identify the devices that do not have an intended medical purpose but are covered by the EU-MDR.
7) Explain the four classes of medical device according to the EU-MDR and demonstrate describe the different rules that are used to classify a device.
8) Determine the classification of a device based on the intended use.
9) Describe and demonstrate understanding of the conformity routes that can be used for the different device classes and explain the extra scrutiny that is applied for higher risk devices.
10) Describe the obligations of the economic operators and the Person Responsible for Regulatory Compliance (PRRC).
11) Outline the requirements for distance sales, claims about the device, the use of
harmonised standards and common specifications.
12) Recognise the different roles associated with placing a device on the market and explain each of their responsibilities: including those of manufacturers, Authorised
Representatives, importers and distributors.
13) Describe the requirements set out for the implant card, single use devices, Declaration of Conformity and the CE marking of conformity.
14) Describe the requirements for devices with special purposes, systems & procedure packs, parts & components and free movement.
15) Explain the General Safety and Performance Requirements.
16) Explain the requirements for establishing the Technical documentation.
17) Identify and explain the requirements for post-market surveillance and vigilance.
18) Explain the difference between proactive and reactive post-market surveillance.
19) Explain the clinical evaluation and clinical investigation requirements.
20) Describe the clinical evaluation process and the equivalence criteria.
21) Outline and demonstrate understanding of the contents of the Post-Market Clinical Follow- Up plan and report, and the purpose and contents of the Summary of Safety and Clinical Performance.
22) Explain the different sections of the UDI barcode.
23) Outline the timelines for applying a UDI number to each class of device.
24) Describe the purpose of EUDAMED and the application of its seven sub-databases.
During the two and a half days participants will acquire and develop specific knowledge in the Medical Device Regulation (EU-MDR 2017/745). This course will help such learners apply their prior quality management knowledge in medical device to understand the requirements of the EU-MDR 2017/745.