Tag Archives: notified bodies

Unannounced Inspections by Notified Bodies a ‘Principal Challenge’ for 2015

By MedTech Intelligence Staff
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With decreasing prices and increasing regulation, many UK medical device businesses are looking to emerging markets for growth. However, compliance issues are also problematic in those territories, according to a recent study from life science consulting firm Maetrics.

With decreasing prices and increasing regulation, many UK medical device businesses are looking to emerging markets for growth. However, compliance issues are also problematic in those territories, according to a recent study from life science consulting firm Maetrics.

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EU Notified Body Unannounced Audits and Your Suppliers

By Richard Vincins
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The most important part to remember about this recommendation document for unannounced audits is that it not only applies to medical device manufacturers, but also significantly includes their suppliers and subcontractors.

The most important part to remember about this recommendation document for unannounced audits is that it not only applies to medical device manufacturers, but also significantly includes their suppliers and subcontractors.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

MDD – Article 16

By Dr. Christopher Joseph Devine
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Dr. Christopher Joseph Devine, President, Devine Guidance International

Article 16, of the Medical Device Directive delineates the requirements for “Notified Bodies.” The notified body is authorized to issue certification, and can take away the certification; the CE Mark of registration belongs to the notified body; if a certificate is withdrawn, manufacturers must remove the CE Mark of conformity; and Competent Authorities can suspend or revoke a certificate if the devices are found to be unsafe or ineffective.

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