Implementation of Medical Device Regulation for CE Marking Training Course

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.

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

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

What will I learn?

  • 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

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)

What's included?

  • You will gain 8 CPD points on completing the course
  • Training course notes
  • Lunch
  • Refreshments

 

In-house training

If you have a group of people to train and a single location that is practical, an expert tutor can deliver training at your premises. Want to know more?

 

Request an in-house training quote >

Course Resources

Download course guide (PDF)


COVID-19: Important information on classroom-based training courses

BSI is closely monitoring UK Government Advice regarding the safety of classroom-based training courses. We’ve been working with all our venues to ensure that COVID secure measures are in place and a member of our team has visited each venue to personally check things over. Enhanced cleaning procedures have been implemented, food and beverage offers adapted, and meeting room layouts have been modified to enable socially distanced events – with anti-bacterial gel and wipes readily available.

If you have any questions regarding your booking of a classroom-based training course, please contact training@bsigroup.com or call +44 345 086 9000.