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Requirement UX: Tables of Contents for the new Medical Device Regulations in EU

15th May 2017

Dear Reader,

If you need Tables of Contents for the new European Medical Device Regulations, like we do, please download them from here: 

Table of Contents – Medical Device Regulation (MDR) 2017/745
Table of Contents – In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746

The Tables include links to the regulations, as published in their final format on 5 May 2017, in the Official Journal of the European Union. If you need translations or other information related to these regulations, follow these links to the EUR-Lex site of the MDR and the IVDR. If you need to make translations of the Tables, please contact us and we’ll provide you with the originals in Word format, so you can modify them and perhaps kindly share to others. If the Tables contain any errors, please let us know and we’ll update them.

This seems like a minor issue in the world of Regulatory Affairs. However, any lengthy document should contain a Table of Contents, especially such commonly used tools as regulations. That’s very basic User Experience (UX) design. I know many of you are crafting your own Tables of Contents for your organization’s purposes on various regulations. Just imagine the amount of working hours that would be saved in organizations globally, if the regulator took the initiative to write the Tables for us. In comparison, the US Food and Drug Administration (FDA) has a more user-friendly and electronic approach on regulations. Yet, their vision is something much more holistic than that: Envision the obvious effects the FDA’s Case for Quality and Voluntary Compliance Improvement Program will have on innovation. By tearing down regulatory barriers and applying the UX design thinking across the board, we will end up with many great improvements in health!


Posted by Heikki Pitkänen

Heikki Pitkänen
Heikki is backed up with 20 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.

Phone: +358 20 773 9510

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