Mika Reinikainen, LL.M., MBA is the founder and Managing Director of AbNovo Ltd.
In the first 12 years of his career, Mr Reinikainen was in charge of European Corporate Regulatory Affairs for Pfizer Hospital Products dealing with a variety of products of the company’s subsidiaries such as orthopaedic implants (Howmedica), cardiovascular implants and devices (Shiley), sutures (Deknatel), blood pumps (Stöckert), electrosurgical equipment (Valleylab), ostomy products (United), angioplasty catheters (Schneider) and penile implants (AMS). He then joined the law firm Hogan & Hartson (now Hogan Lovells) for two years as Legal Counsel responsible for the European health care practice.
He was invited to join Medical Technology Consultants (MTCE) in 1994 and remained with the company when it was acquired by Quintiles (now IQVIA) rising to the position of Vice-President. He founded AbNovo Ltd in 2007.
Mr Reinikainen has been involved directly in the development of the Medical Devices Directives (as Consultant to the European Commission and through trade associations). He headed the working group that developed the European medical device classification system and subsequently chaired the European Commission’s Working Group on Classification. This classification system has been adopted by the Global Harmonisation Task Force (GHTF) and many countries around the world (Australia, Canada and Japan). He has also directly contributed to the development of Commission’s guidance (MEDDEV documents) on classification, vigilance and the drug/device borderline. He has been involved in the development on the technical standards on labelling of medical devices and the medical device nomenclature as Chairman of CEN TC 257 and risk analysis as a member of that group.
He is a founder and Chairman of the European Association of Authorised Representatives (EAAR). and of the UK Responsible Person Association (UKRPA). He is also past Vice President Europe of the Regulatory Affairs Professionals Society (RAPS).
He received his Master’s Degree in Law from the Institute of the Law of Peace and Development, University of Nice, France. He obtained his Master’s Degree in Business Administration (MBA) from the Wharton School, University of Pennsylvania, Philadelphia, USA.