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4 min reading time
A group member asks, “Does a device manufacturing site need to be GMP-certified by local authorities or is ISO certification enough for a CE mark application?”
Dr. Peter Drechsler
And Sarah basically nailed it.
The “manufacturing site” can but must not be the same site as the site of the legal manufacturer. A manufacturing site is considered the site(s), where the device is manufactured. That could be more than one site.
Marketing a device only with a EC-certificate and without a EN ISO 13485 certificate might be difficult. When it comes to tender business, they often require a EN ISO 13485 certificate.
Francisco Revuelta Basagoiti
Sarah H. Stec
For the legal manufacturer, usually the party that would apply for CE marking in the first place, the medical devices directives have their own quality management system requirements (EN ISO 13485:2012 is the voluntary harmonized standard that allows a presumption of conformity to the QMS requirements in the directives). A quality management system that complies with the requirements in the medical devices directives (using EN ISO 13485:2012 as a tool to get there) would be needed for a medical device CE marking application. A Notified Body would assess the QMS and the product to ensure their conformity with the appropriate medical devices directives and harmonized standards (if you claim conformity to them) that you would use for CE marking purposes.
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