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Successful Medical Device & IVD Post Market Surveillance and Vigilance Reporting

Includes the NEW Medical Device and IVD Regulations

7 - 8 October 2020

Radisson Blu Edwardian Kenilworth, London

The PMS requirements of the Medical Device Regulation (MDR) apply to all manufacturers of medical devices from May 2020, even those who continue to place legacy devices on the market (devices certified under the AIMDD or MDD). However, because the implementation of Eudamed (the European database) has been postponed, all medical devices will continue to be subject to some of the provisions of the directives, including those that have achieved CE marking under the new Regulation.

Using a combination of theory and practical case studies, this course will clarify the transition of old requirements to new ones and will allow delegates to develop the knowledge needed to build successful PMS strategies and understand the latest requirements and technologies for reporting vigilance.

  • Build successful PMS strategies to protect device sales revenues
  • Gain a clear understanding of your responsibilities as a manufacturer to ensure compliance with the requirements of the new Regulations
  • Cut through the confusion arising from the postponement of Eudamed and the application of the new requirements on legacy devices
  • Ensure you know how to best manage adverse incidents
  • Be prepared to meet the challenges of globalised PMS and emerging technologies

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 is relevant to medical device and IVD regulatory affairs professionals who wish to develop their understanding of PMS and vigilance:

  • Vigilance
  • Regulatory Affairs
  • International Regulatory Affairs
  • Safety specialists
  • Compliance Managers
  • Quality Assurance
  • Quality Compliance

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

Led by Richard Young, trainer for MDTI's 'Managing the Transition to the new IVD Regulation' and 'Practical Guidance for Medical Device Audits and Inspections' courses, this c. 20 minute webinar covers:

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


The interaction with the trainer and other participants with a focus on practical exercises was very useful.

Product Compliance,

 A Menarini Diagnostics

The depth of knowledge of the presenter and breadth covered in the course was excellent.

Regulatory Affairs Manager,

 The Binding Site

I enjoyed all the examples given during the presentation as well as the vigilance content and information/experience shared between attendees.

Regulatory Affairs Communications Co-ordinator,

Cook Medical

Free Webinar : Future European Regulation of In Vitro Classification

Led by Richard Young this high level 30 minute webinar provides you with valuable updates and insights into the new classification system proposed in the new IVD Regulation. You will gain solid grounding in the new risk based approach to classification so you can begin to evaluate your diagnostic products and prepare for the future changes.

Regulatory update and impact on the IVD industry
Outline of changes to classification: A risk based approach
Reviewing Annex VII: Rule 1- 8

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