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Paragraph 1 General requirements

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

(1)

The device shall be designed and manufactured in such a way that, when implanted under the conditions and for the purposes laid down by the manufacturer, its use does not compromise the clinical condition or the safety of the patient.

(2)

The device shall not present any foreseeable risk to the person implanting it or to other persons.