Before placing his products in the EU market, the manufacturer of the medical devices has to get them CE marked. This is to make sure that the medical device complies with all the needful requirements of health, safety and environmental protection benchmarks.
The requirements with which a medical device manufacturer has to conform are given in the Medical Devices Directive of the European Union.
This directive is a collection of 3 directives which are:
- Active Implantable Medical Device Directive (AIMDD 90/385/EE)
- Medical Device Directive (MDD 93/42/EEC)
- In Vitro Diagnostic Medical Device Directive (IVDMDD 98/79/EC)
According to this directive, there are 4 categories in which the medical devices can be classified. The categories are:
- Class Ⅰ (includes Is and Im)
- Class Ⅱa
- Class Ⅱb
- Class Ⅲ
Class Ⅲ is ranked as the highest classification. The assessment of the product depends upon category in which it falls. The higher the class of the product, the greater will be the level of the assessment required by the Notified Body.
Eurotech Assessment and Certification Services Pvt. Ltd. is a Notified Body that provides CE Mark Certification. We assist you in meeting all the legal requirements of the European Directives to open the European Market for your product. We not only provide CE Mark Certification for your medical device but also provide testing services for the same through our sister concern.
Drop your queries at firstname.lastname@example.org to know more about our CE Certification Services.