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 mark 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 CE marking process or guidance for certain components, AXSource Consulting can help you in various ways:
1. Attaining compliance, recommending practical suggestions, as well as advice and guidance
2. Determining the relevant EU directives and standards applicable to each product
3. Outlining your role & responsibilities under EU product safety directives
4. Determining the need of a notified body required to enable you to achieve compliance
As a result of our deep domain knowledge and functional expertise, we can offer you the following CE-marking services:
1. Advice on the CE-marking process
2. Conformity assessment
3. Verification of design
4. Type approval
5. Design Dossier / Technical File
6. File and document assessment
7. Workshops and Training
8. Risk analysis and assessment