Comments on the Confusing Lack of Regulatory Provisions for Own-Brand Labelling of Medical Devices in Europe from QFI

London, United Kingdom, May 03, 2011 --(PR.com)-- No regulations on the own-brand labelling of medical devices exist in the European Union, which is the essence of the problem elucidated in an article published in the May 2011 issue of the Journal of Medical Device Regulation (JMDR). The article is entitled "A Confusing Lack of Regulatory Provisions for Own-Brand Labelling of Medical Devices in Europe" and is written by Haroon Atchia, a member of the JMDR’s Editorial Advisory Board and CEO of Quality First International, London, UK.

The ever-expanding popularity of own-brand labelling as a means of acquiring exclusivity and reducing costs across numerous industries is also evident quite prodigiously in the medical device industry. "For instance, the ease by which manufacturers can affix the CE mark of conformity might appear consonant with the concept of free movement of goods but actually undermines regulation, satisfactory quality, safety and performance," says Haroon Atchia.

In his article, Haroon Atchia highlights many of the common regulatory problems and misconceptions surrounding own-brand labelling, particularly with respect to the person responsible as the manufacturer. He urges the Commission to introduce a legal basis for own-brand labelling, which could include banning the practice for high-risk devices, introducing registration for all own-brand labelled products, and requiring the addition of a symbol to identify an own-brand labelled version of an original device. Direct guidance published by the Commission is also needed, perhaps alongside a harmonised standard.

Mr. Atchia also suggests that Notified Bodies be designated to assess the conformity of own-brand labelled products to ensure their competency.

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