Implementation MDR for CE Marking Training

This three-day course from your partner in learning is especially useful for regulatory affairs, quality management and quality assurance professionals who need to implement the medical device regulation (MDR). The MDR training is also designed for people working for organizations that partner with Medical Device manufacturers.

You will learn all the requirements needed for conformity assessment, how to fulfil technical documents and how to plan post-market activities required by the MDR. By the end of the course you will be able to put all this knowledge into working practice in your organization.
With the opportunity to gain eight CPD points on completion and comprehensive training notes, this MDR training is everything you need to guide and support others.

How will I benefit?

This course will help you:

Comprehensive understanding of the European medical devices regulation
Support other people and partner organizations affected by MDR
Organize required documentation
Follow the necessary steps for your organization to meet the MDR requirement MDR 4

Who should attend?

The course is especially suitable for:

RA, QM, and QA professionals who need to implement the MDR
Anyone concerned with certification or active in projects for CE-marking
Staff working for organizations that partner with Medical Device manufacturers e.g. as subcontractor, crucial supplier, OEM, Authorized representative, importer, distributor, auditee

What will I learn?

By the end of the course delegates will be able to:

Develop a strategy for regulatory compliance as stipulated by MDR
Implement requirements concerning the following steps for Conformity Assessment:

Scope and applicability of MDR
EU risk classification criteria for medical devices to determine “Risk Class”
General Safety and Performance Requirements (GSPRs) as the basis for CE marking, including the use of standards
Conformity assessment routes and their application based on risk class
Self-certification, CE-certification by Notified bodies, involvement of authorities, scrutiny
‘Declaration of Conformity’ and CE marking

Fulfil Technical Documentation requirements, e.g. in

Putting together ‘Technical Documentation’
Necessary control of outsourced activities and processes and roles of external partners (e.g. supplying and commercial)
Instantiate the importance and role of clinical data
Risk management, process validation and their regulatory significance
Drawing up Instruction For Use, label and other information supplied with the device
Consistency and validity of information and electronic data management

Plan post-market activities required by MDR with respect to:

Risk Management and related planning
Post-Market Surveillance and Post-Market Follow-Up (PMCF)
Periodic reports, Vigilance, ad-hoc reporting
Regulatory responsibilities of all economic operators including communication with competent authorities, notified bodies, economic operators, customers etc.
Recall, Field Safety Corrective Actions (FSCA), Corrective And Preventative Action (CAPA)
Regulatory relevance of change control to QMS, design and manufacturing
Extent of readiness for audits/reviews/assessment

Put into effect gained knowledge concerning implementation of MDR requirements into your organization, e.g. in projects for CE-marking

What is included?

On completion, you will be awarded an internationally recognized BSI Training Academy certificate.

BSI's Medical Devices Regulation (MDR) Qualifications

Medical Devices Regulation (MDR) Qualifications

This course forms part of our MDR Practitioner Qualification. This qualification will give you a BSI Mark of Trust, reassuring your customers and suppliers that your skills have been validated. You can achieve Practitioner status by successfully completing courses and exams.

I'm interested, please send me more information about the course.

Prerequisite

You must have a good understanding of the requirements in the MDR, which is conveyed by our one-day Requirements training course or our MDD to MDR transition course.

You should also have either experience with, or basic knowledge, of quality management systems for the medical device industry, or good understanding of European Medical Device legislation, or some experience in pre-or post-market activities within the EU.

Please note:
This course will not cover implementation for In Vitro Diagnostics or concentrate on devices with specific requirements.