[Open Design + Hardware] Liability in hacking medical equipment

Sat Nov 9 17:49:14 UTC 2013

Hi guys,
I am writing you with a question that I got from Jesper a friend that is
involved in a maker-space in Roskilde, Denmark. It a nutshell is about how
to deal with liability when organizing workshops where people is invited to
hack their own assistive technology (please scroll down for a more detailed
description of the issue).

Do you have any tips, contacts, experiences that could help with this?

ciao!
anNa

2013/11/8 Jesper Holck <jesper.holck at roskilde-festival.dk>

>  Hi Anna,
>
> As promised, I send a few words describing our concerns about liability.
>
> As part of our makerspace in Roskilde, we're planning to also work with
> assistive technology devices (hjælpemidler, hjälpmedel). In Denmark, and I
> guess in Sweden also, these are under heavy regulation, and manufacturers
> must get their products certified. In Denmark, they are classified as
> medical equipment.
>
> You are of course allowed to make small repairs, decorations, and
> maintenance of assistive devices. But you are not allowed to make
> constructive changes. Or rather, if you make constructive changes, you
> should get a new certification of the device.
>
> I talked to the Danish "lægemiddelstyrelse" (the Danish governmental
> office for medicine and medical equipment) and they said, that we as a
> makerspace may be liable for the changes our users make to their assistive
> devices.
>
>
> Warm regards,
> Jesper
>
>
> --
> Jesper Holck
> Project Manager
>  <http://orangeinnovation.dk>
> www.orangeinnovation.dk
> www.twitter.com/orange_inno
> www.orangeinovation.dk/blog
>
> Skype: jesper.holck
> Mobile: +45 29467652
>
> Roskilde Office:
>
> Havsteensvej 11
> DK-4000 Roskilde
> Tel.: +45 4636 6613
> Fax: +45 4632 1499
>
>
> Cph Office:
>
> The Hub, Nørrebrogade 52 B
> DK-2200 København N
>
>
>
>
>

-- 
>>>>>>>>>>>>>>>>>>>>>>>>
Anna Seravalli
PhD Candidate Research Fellow
MEDEA Collaborative Media Initiative
Malmö University

+46 72 744 55 24

medea.mah.se
prototypingalternativefutures.wordpress.com
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