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Human enhancement: will the integration of technology and humanity create a regulatory dilemma?

This article was originally published in Clinica

Executive Summary

Imagine a future where the human brain can be enhanced to optimise its control of the body and speed up its computing functions. There are already products on the market that enable the brain to directly control devices, but more far-reaching developments are around the corner. Should medical devices intended for human enhancement fall within the scope of the medical device directives? Abnovo consultant Mika Reinikainen considers the possibilities for regulating the technologies that could change what it means to be human

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Effective representation of non-European manufacturers: revision progress and way to go?

Non-European medtech manufacturers need representation in the EU, a market that may otherwise confound them. But how clear are the rules on representation? Mika Reinikainen applauds developments there have been in this area and pins his hopes on further clarity brought about by the European Commission's medical device and IVD regulation proposals. But some further work is needed to avoid confusion in the area of market surveillance

Effective representation of non-European manufacturers: revision progress and way to go?

Non-European medtech manufacturers need representation in the EU, a market that may otherwise confound them. But how clear are the rules on representation? Mika Reinikainen, chair of the European Association of Authorised Representatives (EAAR), applauds developments, and pins his hopes on further clarity brought about by the EU Commission's medical device and IVD Regulation proposals. But some further work is needed to avoid confusion in the area of market surveillance

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