European Medical Device Regulations MDR & IVDR - A Guide to Market

Business Finland has been seeking ways to make the transition into the new EU Medical Device Regulations MDR & IVDR smoother for the Finnish health tech sector, and especially for the small and medium size enterprises. For that, Business Finland published a 101 guidance booklet with focus on the MDR & IVDR in December 2020.

The work was carried out by Lean Entries together with Tom Ståhlberg, whose narrative in the original booklet published by Tekes regarding the current EU Medical Device Directives has been widely appreciated by the Finnish health tech industry. The new booklet was published in English and it highlights efficient regulatory compliance not only as a business mandatory, but as a business advantage, guiding innovators to systematically develop safe and effective solutions.

THE AUTHORS

Heikki Pitkänen is the CEO & Founder of Lean Entries Ltd, a group of regulatory compliance professionals providing digital regulatory runway services and training to health tech startup incubators and university innovators, as well as traditional regulatory consulting services for start-ups and experienced teams. Heikki has 20 years of experience from the health tech field and worked previously as a site manager at SGS, providing medical device manufacturers with Notified Body, accredited test lab and training services for worldwide market access. Heikki has participated in international standardization, for example, in the CEN-CENELEC Advisory Board for Healthcare Standards.

Leena Raunio is an experienced regulatory and quality professional who has worked at numerous medical device manufacturers ranging from biodegradable orthopaedic implants to health software. She has supported many more medical device manufacturers and other stakeholders as a regulatory consultant throughout her career that spans 20 years.

Ilona Santavaara has worked on compliance for her entire career, starting from consumer electronics and environmental and material compliance. For the past seven years, she has been guiding various health tech companies with medical device regulations. Her experience ranges from the compliance of artificial intelligence software to hands-on clinical evaluation.

Tom Ståhlberg has spent decades in the global in vitro diagnostics market and provides training and consulting services on EU, US FDA and other international MD and IVD regulations through his company RaLex Partners. Tom's experience spans from marketing to regulatory director's position in a multinational IVD company, from which he transferred to Healthtech Finland to guide the Finnish health tech sector and to make an initiative to write the first edition of this book. Throughout his career, Tom has been active in medical device and IVD standardisation on the international scale both within ISO, CEN-CENELEC and CLSI and participated in the regulatory committees of EDMA and COCIR.

BUSINESS FINLAND

Business Finland is the Finnish government organisation for innovation funding and trade, travel and investment promotion. Business Finland's 600 experts work in 40 offices globally and in 16 regional offices around Finland. Business Finland is part of the Team Finland network.

The booklet is available here.