Implementation of the legal and ethical requirements

The document has to be read in continuity with D6.1 ‘Legal and ethical requirement’. The document
takes in legal considerations, practical guidelines and recommendations. In particular, it con-
tains: (1) PDP guidelines to the Consortium partners for the execution of project initiatives
and for the development of the Careables.org platform as well as PDP guidelines for designers
and makers of Careables; (2) IPRs guidelines for the management of intellectual property
rights during the development of a Careable; (3) key considerations and recommendations to
explain with simple references the key concepts of tort law and liability for Careables makers
and designers; (4) legal considerations on the application of MDL and the notion of manufac-
turer according to EU law as well as MDL guidelines on how a given item may qualify as a
medical device.
The overarching objective of the document is to explain, in a plain and comprehensive man-
ner, the key ethical and legal elements that might be relevant for the Made4You project and
the Careables by providing at the same time easily understandable ethical and legal guidance.
Ultimately, the document should guide the Consortium partners and open healthcare inter-
ested audiences for the execution of co-design and creation processes for open health care
solutions towards an ethically and legally sound approach.