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Medical
Device & OWN BRAND LABELING or OWN BRANDING or PRIVATE LABELING of Medical Devices including IVD's ...
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The OEM The original body who CE Marked the Products is known as the ORIGINAL EQUIPMENT MANUFACTURER or OEM. The OBL Company The Company who is placing their Company name on an existing CE marked product is referred to as the Own Brand Labeler or OBL Company.
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PRE-REQUISITES: • Full cooperation of the OEM (Original Equipment Manufacturer) is mandatory. • Documentary evidence of EC Certification of the original product is mandatory. •The OEM product which is to be Own Brand Labeled must not be altered in anyway from the original product; (That is apart from Labels and Instructions For Use). •The OBL company must implement basic GMP controls to ensure integrity of product at all times. •The OBL company must implement procedures to ensure that all necessary Post Sales Issues are effectively addressed (eg: Vigilance, Recall, FSN Issue (Field Safety Notice), Post Market Feedback etc etc). • The OBL company must acknowledge that in Own Brand Labeling a product, they are accepting all responsibility for the product, as if they had manufactured the product themselves.
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The following link is to the MHRA's Web Site guidance on this issue;
http://www.mhra.gov.uk/Howweregulate/Devices/Ownbrandlabelling/index.htm Medical Device & QA Consultancy offers a Professional and Least Effort Approach to meeting all the Regulatory Requirements for a Fixed Minimum Cost. Contact us for help in by e-mailing us at:
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