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A Confusing Lack of Regulatory Provisions for Own-Brand Labelling of Medical Devices in Europe

London, 28 April 2011 – 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.

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.

About the Journal of Medical Device Regulation

The Journal of Medical Device Regulation is intended to educate, provide professional guidance, develop core competence of regulatory professionals, and promote debate on fundamental and topical matters within the medical device industry. In addition to publishing review and discussion articles by opinion leaders from the device community, the Journal summarises the news headlines from around the world and provides useful reference information in the form of charts and briefing documents. The Journal is a quarterly, subscription-only publication which is currently only available in electronic format. Full articles are only accessible to subscribers of the JMDR.

For Further Information

For more information on the Journal of Medical Device Regulation, please contact Marija Capek (tel: +49 (0)176 212 444 26) or visit the Global Regulatory Press website at

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