In order to work towards market implementation REACH needed to clarify and sharpen the medical purpose of its solutions, develop a regime for market segmentation, facilitate the preparation of medical certification and IPR protection activities, and define concrete business and marketing procedures.

The REACH consortium linked up with consortium-internal and consortium external experts in the field of medical certification, and is at present pursuing the following steps towards a medical certification plan:

1. Clear definition of the medical purposes and medical claims for each Touchpoint
2. Revision and refinement of a) medical claims plus b) the with these claims associated necessary verification/validation procedures towards medical certification.
3. Risk analysis (key to plan the clinical evaluation and certification roadmap) – Identification and evaluation of risks for end-users and caregivers associated with the REACH solutions in question.
4. Identification and analysis of standards (ISO, IEC, etc.) that need to meet in the context of each claim/sub-system.
5. Final positioning – alignment of medical claim and assignment of the REACH solution to a specific medical device class.