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Medical Devices Regulatory Affairs Introductory Course

Medical Devices Regulatory Affairs Introductory Course
Introduction to Medical Devices Regulation in Europe: Providing those new to Medical Device Regulatory Affairs with an understanding of the regulatory requirements for medical devices in the EU.


With a growing trend in the crossover between pharmaceutical and medical device regulatory affairs, it is becoming increasingly important for pharmaceutical regulatory professionals to be aware of the issues surrounding medical device regulatory affairs.

Put together by practising medical device regulatory affairs professionals, 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. 

After three days you will return to your office a more confident and proactive medical device regulatory affairs professional who will be able to determine which directives apply to which products, classify medical devices, assess borderlines issues and establish and maintain an internal audit programme and a supplier audit programme. 

The course will also enable you to prepare and manage a third party audit, recognise diverse country requirements, advise on how to conduct a clinical investigation and implement a copy approval process.


What else will I learn?

  • 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

There will be an international speaker panel with representatives from industry, contract houses, notified bodies and regulatory agencies and the course will be a mixture of lectures and interactive case studies that will help you to put theory into practice. There is also the unique opportunity for you to meet and interact with peers and network with a large variety of leading industry and regulatory agency specialists.

What previous delegates said:

"I got a very good overview of medical devices, which I will use in my job."
    "I got a very good overview of medical devices, which I will use in my job." 
"I was just delighted to see that this course was just what I have signed up for."    
    "I do feel much more confident in my role as a Regulatory Affairs Analyst and 
now have access to resources, references and guidances to help me find answers directly."
 "I was impressed by the high level of presentations and presenters."  

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Registration fees

Member: £1,500 + VAT
Non Member: £1,700 + VAT

- All fees are shown in Pounds Sterling and include VAT (where applicable) Terms and conditions
- Please note the registration fee excludes accommodation.  Further details on how to book accommodation will be sent with the detailed confirmation letter.
- Refreshment breaks, lunch for three days and two evening meals are included in the registration fee.
- Personnel in full-time education, working in academia (full-time) or working for a statutory regulatory body may be entitled to a discount on the above fees. Please contact the TOPRA office for details.

07/06/2017 - 09/06/2017
The Medical Devices Introductory Course Novotel Greenwich Hotel 173-185 Greenwich High Road London SE10 8JA UNITED KINGDOM
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