Private-label manufacturing.
Private, or own-brand, labelling of products is an attractive proposition for manufacturers who may have unique products but lack access to particular markets, or distributors who may have a strong brand identity but lack a suitable product. However, care must be taken to ensure that private-labelled products comply with the Medical Device Directive and confusion may arise over who takes responsibility for compliance issues. This article looks at the alternative proposals for resolving this confusion and at some of the requirements for compliance.
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Product Certification Division, British Standards Institution (BSI), London, UK.
D004864:Equipment and Supplies; D005060:Europe; D005161:Facility Regulation and Control; D019983:Guideline Adherence; D006801:Humans; D017149:Private Sector; D011356:Product Labeling / Q000592:standards*