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Advanced Regulatory Affairs for Medical Devices

Gain advanced tools necessary to implement regulatory requirements

Dates TBC

Radisson Blu Royal Hotel, Brussels, Belgium

Designed for professionals with a working knowledge of regulatory affairs, this advanced course will provide a road map to support your transition from the current regulatory system based on Directives to the new requirements established by the Regulation. The course will include comprehensive sessions on: technical documentation, the vigilance system, the regulatory hierarchy in the EU, labelling, clinical evaluations and investigations, EUDAMED, post-market surveillance and post-market clinical follow-up studies.  
On completion of this 2-day course you will have a more strategic grasp of the new Medical Device Regulation (MDR) and best practice to help transition from the Directive. You will explore key regulatory changes to the regulation from conformity assessment and clinical investigations to the new vigilance system and post-market surveillance.  
As a senior Medical Device professional, this course will provide you with a platform to discuss and share your challenges and concerns in a learning environment. Together you will discuss solutions that you can take away and apply in your roles. Dependent on delegate wishes, some time may be designated to discuss the implications of Brexit and future challenges for industry. 

  • Understand the reason behind the new Medical Device Regulation
  • Explore the changes to roles and responsibilities of key stakeholders including competent authorities, notified bodies and economic operators
  • Investigate classification rules and processes, including software products
  • Analyse the General Safety and Performance Requirements and technical documentation requirements
  • Examine the guidance and requirements for clinical evaluations and investigations
  • Understand the different conformity assessment routes
  • Comprehend market surveillance tools such as EUDAMED and UDI
  • Implement effective post-market surveillance and vigilance strategies
  • Understand the different requirements and types of post-market clinical follow-up
  • Critically analyse the impact of Brexit and future trends/challenges in the industry

Mika Reinikainen

Mika has a Master’s degree in Law from the University of Nice and later gained a Master’s in Business Administration from the Wharton School.

He has more than 30 years of experience managing European medical regulatory affairs in industry, as a healthcare legal counsel and as a regulatory consultant. He has also been involved directly in the development of the Medical Devices Directives and of technical standards since the 1990s.

He founded the medical device consulting company Abnovo Ltd in 2007 to provide a wide variety of networked services to the medical device industry worldwide.  

He is currently a member of various medical device expert working groups of the European Commission and is Chairman of the European Association of Authorised Representatives (EAAR).

This course will provide experienced professionals with the regulatory knowledge to practically apply life-cycle management in an MDR environment, particularly to those who play a key role in transitioning their products to the MDR.

ISO 13485:2016 – An Overview of General and Product Realisation Requirements

Led by Richard Young, this 20 minute webinar covers:

- Impacts of the new revision
- New terminology
- General requirements
- Resource management
- Product realisation and design controls
- Q&A session

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