Managing Director, Abnovo, UK
Mika Reinikainen is a founder and Chairman of the European Association of Authorised Representatives (EAAR).
He is the founder of Abnovo Ltd, a medical device consulting company. Previously, he served in the position of Vice President at Quintiles. His company 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.
Mr. Reinikainen has more than 30 years of experience in the European medical device field: as regulatory affairs manager in industry (Pfizer Hospital Product Group of companies), as healthcare legal counsel (Hogan & Hartson) and as as a regulatory consultant (Medical Technology Consultants Europe, BRI and Quintiles).
He was directly involved in the development of the Medical Devices Directives (chairing the working group that developed the European medical device classification system and later as a consultant to the European Commission on classification) as well as through various roles in trade associations. He also served as the former Chairman of CEN TC 257 (technical standards).
Mr. Reinikainen is currently a member of the European Commission’s Medical Device Expert Group and of the Commission’s Working Groups on Borderlines and Classification, Software and New & Emerging Technologies. He is a former Vice President, Europe, of the Regulatory Affairs Professionals Society (RAPS).
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).