Hi,
MDD Article 12 and MDR Article 22 states about systems and procedure packs which operates with other CE marked devices whether they are packaged together or not.
Does anyone have information of the definitions of "systems" and "procedure packs"? Or has information what level of interoperation/interconnection would fall MDD Article 12 which requires declaration of mutual compatibility is needed?
There are many devices are in the field operated together such as PACS operates with all radiology data from devices manufactured by various firms. Moreover, there are many devices which operated with other devices to enhance its performance such as digital X-ray upgrade retrofit kit operated with conventional X-rays, some devices have wired connection some devices doesn't have any connection with conventional X-rays.
Thanks in advance.
JP
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Jeongpyo Hong
Sr. Professional, Regulatory Affairs
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Jeongpyo Hong
Sr. Professional, Regulatory Affairs
Seongnam
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