In the European Union (EU), CE-marking is a compulsory conformity mark required for a wide variety of products such as medical devices for trade and commercial purposes.
More specifically, medical devices, that fall under the European New Approach Directives (EU Directive 93/42/EEC and 98/79/EC) and regulations, must be CE certified.
CE-marking specifies that the product complies with stringent EU product safety directives. However, achieving CE marking compliance can be a complex and challenging process.
A detailed assessment needs to be carried out to ascertain which directive applies to a medical product. The EU regulations include 3 product groups for medical devices:
1. Medical Device (MD)
2. In Vitro Diagnostic (IVD)
3. Active Implantable Medical Device (AIMD)
Diverse categories and associated certification processes are applicable for each product. The very first step in the overall CE marking/certification process for a particular product is to determine which the applicable category of regulations.
At AXSource Consulting, our team of internal experts and technical consultants will determine the appropriate classification of your medical device based on the information available such as:
– Information about intended use (IU)
– Product images
– Characteristics of the product in question
Whether you need support and consulting services for the entire process or guidance for certain components, AXSource Consulting can help you in various ways:
As a result of our deep domain knowledge and functional expertise, we can offer you the following CE-marking services: