Important Information About The Responsibilities Of A Medical Device Manufacturer - RK Rose+Krieger RKPowerlift M Notice D'assemblage

2.2 Important information on the responsibilities of a medical device
manufacturer
These installation and operating instructions are only intended for the medical device
manufacturer for creating an operating manual for the respective medical device (specified as end
product in the following). In accordance with the Medical Devices Act (Medizinproduktegesetz,
specified as MPG in the following) Sections 2 and 3, we see our product as an accessory part for
an emerging overall product in compliance with Section 3 MPG.
As the type of end product in which our certified drive system is to be inserted is beyond our
knowledge, we explicitly refer to the following points:
•
the medical device manufacturer of the end product is responsible for the lawful feasibility,
•
a separate risk analysis must be carried out for the respective end product,
•
our product must be tested for its suitability for the application purpose of the medical device
manufacturer (of the end product),
•
we assume no liability for constructive defects or, also risks originating from our drive system
for the special application case (for example, construction-related crushing and shear points).
A medical device manufacturer is any manufacturer that manufactures products that comply with
Section 3 of the MPG!
These installation and assembly instructions are not intended for the operators, patients or users!
We want to particularly emphasize that only the medical device manufacturer is responsible for
the provision of the medical device operating instructions for the operator/user.
Putting into service is forbidden until the machine complies with the provisions of EC Directive 93/
42/EC (Medical Device Directive). Before bringing onto the market, it must comply with the
EC Directives, including the documentation.
You can find more information and notes under www.rk-rose-krieger.com.
2. General notes
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