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Welcome to our Library of Regulatory, Certification Information and Updates in the Medical Device Area

Recommendation on Unannounced Audits PublishedThis past September, the EU Commission issued a Recommendation (2013/473/EU) on the audits and assessments that notified bodies perform for medical devices.

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ISO 14971A risk management file is an integral part of any medical devices’ technical documentation because it details the hazards and risks linked to the use of a device and how the manufacturer handled them in order to optimize its safety and performances. Manufacturers usually construct the risk management file by continuously analyzing the risks of their devices throughout the devices’ design and development stages.

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Revisions to the Medical Devices DirectivesOn September 26, 2012, the European Commission issued its proposed revisions to the European medical device regulatory scheme to the European Parliament and to the Council. These revisions, if adopted, will have major and long-lasting impact on the medical device economic operators (manufacturer, authorised representative, importer, and distributor) around the world that import their devices into Europe. They will also modify the missions and responsibilities of the European Commission, the Health authorities and the notified bodies.

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Notified Body What Who Where When Why HowThe vast majority of medical device manufacturers who seek to sell their devices in Europe must work with Notified Bodies.

To many manufacturers for whom Europe is a brand-new market, the regulatory scheme and the role of the Notified Body are sometimes difficult to comprehend.

This is because the European CE marking process is different from the medical device approval process in the United States, and a close comparison can be difficult without years of expertise in different regulatory arenas.

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Notified Body Post Market PhaseAs economic belts tighten around the world the medical device industry is one of the hardesthit, as one of the most competitive industries. While competition has increased, medical device recalls around the world have also increased in recent years. European authorities recalled 434 devices in 2008, 611 devices in 2009, and 748 devices in 2010.

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Tech File EvaluationThe technical file is the key to a medical device’s certification for CE marking because it contains the most important information about the device, how it works, how it is manufactured, and how it meets the applicable regulatory requirements.

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Switching your Notified BodyEven though it may seem counterintuitive, it is quite simple to change notified bodies (NB).

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CE Marking of Own Brand Label Devices ManufacturerCompanies often seek to rebrand existing medical devices and sell them under their own name. This process is called Own Brand Labeling and offers faster market entry for companies wishing to build and complete their product portfolio compared to developing a new product.

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