What is the CE Mark and what does it mean?
What is the CE Marking process for medical devices?
Who is responsible for maintaining regulatory compliance?
To sell medical devices in the European Union (EU), you must obtain or apply CE Marking for your product. CE Marking indicates a product’s compliance with the applicable EU regulations and enables the commercialization of your products in 32 European countries. As a legal medical device manufacturer, you are responsible for maintaining regulatory compliance and securing CE marking for your product, regardless of whether you outsource any or all components of your manufacturing operation. IVD? See this page.
How to obtain CE marking for your medical device
CE is not a quality mark, but compliance with EU Directives requires you to meet specific standards of performance, quality, safety, and efficacy for your product type. We have a detailed chart explaining the European CE process here. However, the basic process follows these steps:
We have assisted medical device manufacturers with CE compliance for Europe. Our services include:
ISO 13485:2003 is a quality system standard designed specifically for medical device companies. It is the most commonly chosen path for companies to meet the Quality Management System (QMS) medical device requirements in Europe, Canada, and Australia, and serves as the basis for QMS compliance in other countries such as Japan, Korea, and Brazil.
Advantages of ISO 13485 certification
If you manufacture or market any Class II or higher risk classification device, and you sell it outside the US, most likely you will need to be ISO 13485 certified. ISO certification offers many benefits for medical device companies:
Please contact us for more information on our ISO 13485 consulting services.
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