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ANNEXII
TECHNICAL
DOCUMENTATION
MEDICAL DEVICES REGULATION 2017/745
ANNEX II
ANNEX IX
PAGE 1
ANNEX II
TECHNICAL DOCUMENTATION
PAGE 2
• Applies to devices Class I and IIa
• Device description and specification
• Labe...
PAGE 3
Annex I
General safety and
performance
requirements
Annex II
Technical
Documentation
Annex III
Technical
Documentat...
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