12 results

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Regulation

Posted on 05.03.2018

Invest! Lead! Engage! Let’s Make Europe’s New Regulatory System Work

We are now over 15% of the transition period of the new European IVD Regulation (IVDR) and over 25% of the Medical Devices Regulation (MDR) transition. That said, transitioning to the new system comes with highly-ambitious timelines, and success will require great effort, by industry and authorities alike. Last week, at the Association of the […]

By Oliver Bisazza Director Regulations & Industrial Policy - MedTech Europe

heikki
Regulation

Posted on 06.09.2017

The challenges of a MedTech startup in the land of scattered Regulatory Information

According to the preliminary results of a study* aimed at the Finnish medical device industry, regulatory compliance pops up as the second biggest challenge burdening the industry. This, according to the study, comes in the wake of challenges for establishing effective international distributor channels. To me, this only verifies what I have experienced working in […]

By Heikki Pitkänen CEO & Founder

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Regulation

Posted on 23.08.2017

Feeling lost? Find your direction with the new IVD/MD regulations training

MedTech Europe and IVDR & MDR training: a contribution There has been a lot of noise in the MedTech community on the recently adopted in vitro diagnostic medical devices regulation (IVDR) and the medical devices regulation (MDR). These new regulations were some 10 years in the making, yet many details still have to be clarified […]