Hi Chris,
1. In this scenario where we only ship software and part of the
hardware what are our regulatory responsibilities vs. those of the
distributor?
Answer: Based on the Medical Device Directive, Article 1, paragraph 2.(a),
software is included in the definition of a "medical device". If your name
is on the software and/or hardware you are considered the "manufacture" and
must comply with the MDD.
2. Need we simply ensure the "components" of our system which we
supply to the distributor are CE marked OR should we assemble a complete
representative system as it will be marketed in the EU and perform all
relevant type testing ourselves?
Answer: Most likely you will need to assemble a system. Article 12,
paragraph 2 covers this. See below
2. Any natural or legal person who puts devices bearing the CE marking
together within their intended purpose and within the limits of use
specified by their manufacturers, in order to place them on the market as a
system or procedure pack, shall draw up a declaration by which he states
that:
(a) he has verified the mutual compatibility of the devices in
accordance with the manufacturers' instructions and has carried out his
operations in accordance with these instructions; and
(b) he has packaged the system or procedure pack and supplied relevant
information to users incorporating relevant instructions from the
manufacturers; and
(c) the whole activity is subjected to appropriate methods of internal
control and inspection.
Where the conditions above are not met, as in cases where the system or
procedure pack incorporate devices which do not bear a CE marking or where
the chosen combination of devices is not compatible in view of their
original intended use, the system or procedure pack shall be treated as a
device in its own right and as such be subjected to the relevant procedure
pursuant to Article 11.
3. If we need only CE mark the components we ship -- Is software
typically CE marked? Where does one look for the essential requirements
for software?
Answer: Software is typically CE marked. Even if the software is
distributed over the Internet, it still needs to meet the requirements of
the MDD and be "marked" (e.g. included in the electronic manual). See Annex
I for the ER.
4. If we are only supplying part of the total system (the software
and pager) yet the system design and specifications are ours, are we
still considered the "manufacturer" under the medical device directive?
Answer: Article 1, paragraph 2.(f) defines the "manufacturer" (see below).
Basically, if you name is on the device, you are the "manufacturer".
(f) 'manufacturer' means the natural or legal person with responsibility
for the design, manufacture, packaging and labelling of a device before it
is placed on the market under his own name, regardless of whether these
operations are carried out by that person himself or on his behalf by a
third party.
The obligations of this Directive to be met by manufacturers also
apply to the natural or legal person who assembles, packages, processes,
fully refurbishes and/or labels one or more ready-made products and/or
assigns to them their intended purpose as a device with a view to their
being placed on the market under his own name. This subparagraph does not
apply to the person who, while not a manufacturer within the meaning of the
first subparagraph, assembles or adapts devices already on the market to
their intended purpose for an individual patient;
5. If the distributor places their name on the product, (and
assumes all responsibilities except design) do they become the
"manufacturer"?
Answer: If you name is not on the unit, you are not the "manufacture" and
have no responsibilities under the MDD.
Ned Devine
Entela, Inc.
Program Manager III
Toll Free: 1 800 888 3787 Ext. 671
Direct: 1 616 248 9671
Fax: 1 616 574 9752
e-mail: [email protected]
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