Complete CE certification of medical devices
CE Certification Medical Devices
CE certification of medical devices is mandatory. Medical devices that fall under the European New Approach Directives (EU Directive 93/42/EEC) and the regulations must be CE certified.
An assessment needs to be carried out to determine which directive applies to a medical product. The EU regulations include 3 product groups for medical devices:
- Medical Device (MD)
- In Vitro Diagnostic (IVD)
- Active Implantable Medical Device (AIMD)
Different categories and associated certification processes apply for each product. The first step in the product certification process is to determine which category applies.
Our experts will classify your medical device based on the information provided by you, for example, photos, information about intended use, the manual, and the characteristics of the product in question.
CE-marking on Medical Devices Mandatory
By affixing a CE-marking, the manufacturer, European authorized representative, or importer confirms that the product complies with European safety requirements.
Medical devices that bear the CE-marking have unrestricted access to the whole market within the European Economic Area (EEA). Products that do not comply with legislation and thus bear no CE-marking may not be traded or used within the EEC.
Request a no-obligation consultation with one of our experts at our office. We will explain exactly which guidelines your product needs to comply with and what steps you need to take.
You can find more information about CE certification of medical devices in the library.