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Introduction To Medical Device Regulation in Europe




Chesham, Buckinghamshire, UK


13 Jun 2018 - 15 Jun 2018

Reference No: T1804296-TOP

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Key points about this Training Event

  • The role of the essential requirements / harmonised standards and how to demonstrate conformity
  • The different conformity assessment routes and how to select the most appropriate route for their product
  • The role of risk management in pre and post market phase and be able to advise on a risk management policy and procedure
  • The need for clinical evidence for CE marking
  • The needs of payers and how to include these as part of the development of the device regulatory package
  • The key elements within a PMS system
  • The criteria for vigilance and the Competent Authority (CA) expectations
  • The minimum requirements and CA expectations for implementing an FSCA
  • The impact of marketing literature on regulatory status
  • The unique requirements of the IVD Directive
Event Description

Course Outline:

This newly researched and updated course is demanded by regulatory affairs managers who wish to get their people up to speed on current European medical device regulatory practices. 

When & Where?

13 June 2018 - 15 June 2018

De Vere Latimer Estate 


Course fee for Members: £1,500 plus 20% VAT
Course fee for Non-member: £1,700 plus 20% VAT 

Applicant Requirements
  • Anyone needing to get up to speed on current European medical device regulatory practices
Reference No: T1804296-TOP
TOPRA is the professional membership organisation for individuals working in healthcare regulatory affairs.
We work with our members internationally to enable and promote excellence across the healthcare regulatory profession.


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