Is there a mandatory medical device warehouse standard for europe?

Remus

Involved In Discussions
#1
Hello, Is there a mandatory medical device warehouse standard for europe. There is one for drugs but I couldnt find one for medical devices.
 
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#3
Any QMS for medical devices also applies to the storage of the device in the warehouse. 13485, 9001 or the FDAs QSR are the most common standards used in industry.
 
W

wrodnigg

#4
A specific standard? No
(despite Greece, where they have a specific law for trade and distribution of medical devices).

An explicit (legal) requirement? Yes, from the essential requirements (Annex I of MDD), but they refer to the product:

5. The devices must be designed, manufactured and packed in such a way that their characteristics and performances during their intended use will not be adversely affected during transport and storage taking account of the instructions and information provided by the manufacturer.

7.2 The devices must be designed, manufactured and packed in such a way as to minimize the risk posed by contaminants and residues to the persons involved in the transport, storage and use of the devices and to the patients, taking account of the intended purpose of the product. Particular attention must be paid to the tissues exposed and the duration and frequency of the exposure.

8.3 Devices delivered in a sterile state must be designed, manufactured and packed in a non-reusable pack and/or according to appropriate procedures to ensure they are sterile when placed on the market and remain sterile, under the storage and transport conditions laid down, until the protective packaging is damaged or opened.

And there is the general guideline from the ISO 13485 (preservation of product).
 
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