Implementation MDR for CE Marking Training

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

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

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.

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This training course is HRD Corp claimable programme.

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

Implementation of the Medical Device Regulation 2017/745 (MDR) for CE Marking

Implementation of the Medical Device Regulation 2017/745 (MDR) for CE Marking

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