Mika Reinikainen , LL.M., MBA, is a consultant with more than 30 years of experience in the European medical device field: as regulatory affairs manager in industry (Pfizer Hospital Product Group of companies), healthcare legal counsel (Hogan & Hartson) and regulatory consultant (Medical Technology Consultants Europe, BRI and Quintiles).
Mika Reinikainen set up his own medical device consulting company Abnovo Ltd after leaving Quintiles from the position of Vice President in 2007. His practice focuses on regulatory strategy and compliance as well as resolving manufacturers' conflicts with Notifies Bodies and Competent Authorities.
He also provides regulatory interpretation and advocacy, in particular on borderline determination between legal regimes. He teaches a regular course on post-market surveillance.
He was directly involved in the development of the Medical Devices Directives (as Consultant to the European Commission and through various roles in trade associations) and of technical standards (former Chairman of CEN TC 257). He chaired the working group that developed the European medical device classification system.
He is currently a member of the European Commission’s Medical Device Expert Group and of the Commission’s Working Groups on Borderlines and Classification as well as New & Emerging Technologies. He is a founder and Chairman of the European Association of Authorised Representatives (EAAR).
He holds a Master's degree in law from the University of Nice (France) and a Master's degree in Business Administration from Wharton (University of Pennsylvania, USA).