Transition from directive 98/79/EC to regulation 2017/746/EU

Home > Transition from directive 98/79/EC to regulation 2017/746/EU

Objectives

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  • Understanding the key changes of the transition from the Directive to the New Regulation
  • Communicating the impact of key changes
  • Identifying the key steps for your organisation
  • Explaining the impacts on QMS

Audience concerned

Manufacturers/sub-contractors of DMDIVs:
– Regulatory affairs/quality managers
– Staff with regulatory monitoring tasks
– Heads of Departments such as: Production, R&D, etc.
– Project Managers, engineers

Aim

Further development

Programme summary

  1. Introduction and objectives
  2. Regulations
  3. Regulatory stakeholders
  4. Regulation SOR/98-282
  5. Regulatory counterparty
  6. Quality requirements
  7. Conclusion
  8. Introduction and objectives
  9. Definition and classification of a medical device under the Regulations
  10. New key requirements: the extra evidence to be provided
  11. Recast: implementing technical dossier Annex II and III
  12. Quality Management System: translating requirements into procedures
  13. PMCF, PMS, PSUR, etc. What oversight should be implemented post market launch?
  14. Transition schedule: When must one be ready?
  15. Conclusion

Prerequisites

  • Basic knowledge of the regulation of DMDIVs (In-vitro diagnostic medical devices)
  • Knowledge of Directive 98/79/EC

Duration

1 day
7-hour classroom attendance

Inscription

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