Implementation of MDR for CE Marking - International

Level Implementation Duration 3 day

Available to book: On-demand elearning View dates and book now

Additional information

See other types of training

On-demand eLearning courses International training

This course will help you to implement the requirements of European Medical Device Regulation (MDR) to obtain and maintain CE marks for your product, giving you access to a market with 500+ million people. Find out best practice for assembling Technical Documentation and QMS when placing Medical Devices (MD) on the European Union market.

The course will also review the requirements of, and relationship between, the legal manufacturer, subcontractors/suppliers, notified bodies (e.g. auditing), and economic operators (importers, distributors, EU Representatives) according to their obligations by MDR.

How will I benefit?

This course will help you:

Implement the requirements of the European Medical Devices Regulation
Guide and support other people and partner organizations affected by MDR
Set up and update required documentation
Take the necessary steps for your organization to meet the MDR requirement
Maintain compliance to MDR and other/future documents related to Medical Device legislation
Systematically explore and implement more detailed and updated provisions (e.g. common specifications (CS), acts, standards)

- 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
Please note: This course will not cover implementation for the In Vitro Diagnostics or concentrate on devices with specific requirements.
- You will gain 8 CPD points on completing the course
- Training course notes
- Lunch
- Refreshments
Download course guide (PDF)

Let's shape your organization's future together

Reach out and see how we can help guide you on your path to sustainable operational success.

Get in touch