Common market but divergent regulatory practices: exploring European regulation and the effect on regulatory uncertainty in the marketing authorization of medical products

Abstract:

The medical product sector is characterised by a regulatory patchwork of European and national laws and guidelines operating concurrently with each other. Each of these sectors are characterised by different levels of regulatory uncertainty that may undermine the effectiveness of the regulatory framework. How have European regulation shaped individual product sectors? How has that impacted regulatory uncertainty in that sector? What has been the impact of regulatory compliance? Drawing on documentary research and fieldwork interviews this pilot study conducted in Netherlands, finds that ATMPs and medical device sectors exhibit high level of regulatory uncertainty. Although the sources of uncertainty are varied across each of the sectors. In some instances when regulatory uncertainty have reached unmanageable levels, measures have been taken by regulators to address it. Regulatees themselves have developed a complex compliance strategy that allows them to tolerate and in certain circumstances even circumvent regulatory uncertainty.

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