What is CE Marking

Who is a manufacturer as per CE Marking norms?

  • Any person who is responsible for designing and manufacture and market in EU community in his own name or under his registered trade mark
  •    ie, a natural or legal person,
    • Who assembles the Medical Device
    • Who packs the Medical Device
    • Who changes the intended use the Medical Device
    • Who process the Medical Device
    • Who labels the Medical Device
    • Who signs the Declaration of Conformity (DOC)
    • Who markets readymade products under his own name
    is a manufacturer as per CE Marking norms

  • A legal person wishes to be a manufacturer and subcontract partial or complete design and manufacturing activities, must retain the overall control for the product and ensure that he receives all the information that is necessary to fulfil his responsibilities according to the New Approach directives. The manufacturer who subcontracts some or all of his activities may in no circumstances discharge himself from his responsibilities

As per CE Marking a legal person either places a product on the market under his own name or trademark or modifies a product in such a way that compliance with applicable requirements may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.

CE Marking process
Fee for CE Marking
CE Marking – Role of consultants
Classification of Medical Device as per CE Marking
CE Marking as per Own Brand Labelling (OBL)
Rounded Rectangle: Click HereCE Marking as per Private Label Manufacturing (PLM)
CE Marking of Medical Software
How ISO 13485 is related to CE Marking
Notified bodies for CE Marking
CE Marking as per MDD 93/42/EEC + 2007/47/EC
CE Marking as per AIMDD (90/383/EEC)
CE Marking as per IVDD 98/79/EC
How to affix CE Marking on your product
How to prepare Technical File as per CE Marking requirement.

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