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THE CALL FOR COOPERATION: How to Resolve Global Regulatory Challenges

Dear Reader,

The new European medical device regulations bring with them many awaited improvements. However, the amount of information and the number of cross-references they contain are not easily unlocked. The previous MEDDEVs and other Commission guidelines are now partly integrated with the regulations, but a great deal of updating is still required in order to elucidate the new requirements. Likewise, the effort for updating the harmonized standards, for creating any common technical specifications, or for designating Notified Bodies for conformity assessment activities according to the new regulations is only commencing. There is quite a large workload ahead. It’s easy to predict that the transition times of three years for the MDR and five years for the IVDR will be eventually extended. Many existing medical device manufacturers will manage the transition, but most startups are overwhelmed with the meaning of each requirement, the price tag for reaching conformity and the new lengthy timelines for EC certification.

The amount of knowledgeable people available for the aforementioned tasks doesn’t seem to match the magnitude of the challenges ahead. Therefore, efficient cooperation between the working groups becomes key, and curating their work the utmost challenge. We intend to participate by turning the basic requirements of any regulation into digital paths, and streamlining the ever growing global regulatory realm for all stakeholders, layer by layer, from the bottom up. Years ago, we only had the burning need to make compliance simpler for everyone; now we have a Minimum Viable Product that we can offer and develop further, thanks to the intense cooperation between a variety of knowledgeable people and service providers. We estimate that only these first services regarding qualification and classification of medical devices by the European legislation can save months of effort on a yearly scale in the global medtech industry. But for really making an impact, the cooperation must extend deeper. That is why we are not creating the platform for ourselves, but for all those with related knowledge, with whom we intend to save decades of effort for the medtech industry with compliance-related activities.

We take this opportunity to warmly thank each one of the many people who have contributed to setting up and testing Entries so far! Also, we want to express a warm welcome for every expert with whom we will cooperate in the years to come!

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Posted by Heikki Pitkänen

Heikki Pitkänen

Heikki is backed up with 16 years of experience from the Medical Device industry, most recently from certification bodies, and is active in international standardization. He is passionate with the modern startup, business model and service design concepts and believes in co-operation between knowledgeable parties for reaching great achievements.


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