The definition I used to work with was "anything
that augments or replaces a human function" is a medical device and hence falls
under MDD. Therefore I would imagine wheelchairs and seating systems would be
included.
It is about 7 years since I've had to deal with any
of this stuff, so please regard this as an informed opinion, and not
authoritative!
I've passed the email onto PMG and it came from
BHTA, so I'm assuming there will be representations from these
groups.
Subject: Re: Revision of the Medical
Devices Directive
Hello Aidan , does this include manual and powered wheelchairs and
seating systems ? can you please advise , regards Tony Lewis SRE
.
-----Original Message----- From: A discussion list for
Assistive Technology professionals. [mailto:[log in to unmask]]On
Behalf Of Aidan Parr Sent: 11 January 2006 15:32 To:[log in to unmask] Subject:
Fw: Revision of the Medical Devices Directive
Could you please pass this round to manufacturers, suppliers and
importers of AT equipment as they will be affected by any revisions to the
Medical Device Directive.
Thanks,
Aidan.
Aidan Parr Researcher FAST - Foundation
for Assistive Technology 12 City Forum 250 City Road London EC1V
8AF
Why not
go to the FAST website at http://www.fastuk.org to find out more
about FAST and how you can be involved.
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the latest news on assistive technology why not subscribe to the AT Forum's
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Subject: Revision of the Medical Devices Directive
For the
attention of all manufacturers and importers of Medical
Devices
Dear
Member
The EU is obliged to review the
Medical Devices Directive periodically and you may recall that they
consulted about possible amendments last year. They have now published
the amendments they are proposing to the EU Council for
adoption.
We urgently need you to let us
know your opinion on the amendments and I attach a document herewith which
attempts to summarise the most obvious changes which may cause
problems. The MHRA need as much information as possible, so they can
go to the first meeting at which the proposals will be considered, armed
with evidence regarding the effects of the amendments if they were to be
accepted – that meeting will take place on 23/24
January.
PLEASE THEREFORE LET ME HAVE ANY
COMMENTS, EXAMPLES, ETC BY 18 JANUARY 2006.
I look forward to hearing from
you.
Yours
sincerely
Sarah
(Apologies to those of you who
are not manufacturers or importers – it is difficult to separate you out
from the mailing)