Transition from directive 93/42/EEC to regulation 2017/745/EU

Home > Transition from directive 93/42/EEC to regulation 2017/745/EU

Objectives

  • 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/distributors of MDs:
– Regulatory affairs/quality managers
– Staff with regulatory monitoring tasks
– Heads of Departments such as: Production, R&D, etc.
– Project managers, engineers

Aim

Futher development

Programme summary

  1. Introduction and objectives
  2. Definition and classification of a medical device under the Regulations
  3. New key requirements: the extra evidence to be provided
  4. Recast: implementing technical dossier Annex II and III
  5. Quality Management System: translating requirements into procedures
  6. PMCF, PMS, PSUR, etc. What oversight should be implemented post market launch?
  7. Transition schedule: When must one be ready?
  8. Conclusion

Prerequisites

  • Basic knowledge of medical device regulations
  • Knowledge of Directive 93/42/EEC

Duration

1 day
7-hour classroom attendance

Inscription

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