FDA 510k and EU CE Mark Regulatory Consulting
What is 510(k)?
According to section 510(k) of the Food, Drug and Cosmetic Act, device manufacturers who must register are required to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification – also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.
Thus, “new” devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use.
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What Is CE marking?
The CE marking indicates a product’s compliance with EU legislation and so enables the free movement of products within the European market. By affixing the CE marking to a product, a manufacturer declares, on his sole responsibility, that the product meets all the legal requirements for the CE marking, which means that the product can be sold throughout the European Economic Area (EEA, the 28 Member States of the EU and European Free Trade Association (EFTA) countries Iceland, Norway, Liechtenstein). This also applies to products made in other countries which are sold in the EEA.
However, not all products must bear the CE marking, only product categories mentioned in specific EU directives on the CE marking.
CE marking does not indicate that a product was made in the EEA, but merely states that the product has been assessed before being placed on the market and thus satisfies the applicable legislative requirements (e.g. a harmonised level of safety) enabling it to be sold there. It means that the manufacturer has:
- verified that the product complies with all relevant essential requirements (e.g. health and safety or environmental requirements) laid down in the applicable directive(s) and
- if stipulated in the directive(s), had it examined by an independent conformity assessment body.
It is the manufacturer’s responsibility to carry out the conformity assessment, to set up the technical file, to issue the declaration of conformity and to affix the CE marking to a product. Distributors must check that the product bears the CE marking and that the requisite supporting documentation is in order. If the product is being imported from outside the EEA, the importer has to verify that the manufacturer has undertaken the necessary steps and that the documentation is available upon request.
- Read more at http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/about-ce-marking/
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Last Updated: 2016-01-04