How does CE marking work for medical products?
There are two types of CE Marking product certification for medical products: the Medical Devices Directive (93/42/EEC) and the In Vitro Diagnostic Medical Devices Directive (98/79/EC).
Compliance with the Medical Devices Directive is required for all medical devices being sold in the European Economic Area (EEA) whereas compliance with the In Vitro Diagnostic Medical Devices Directive is required for all in vitro diagnostic products being sold in the EEA. These directive covers all health and safety risks, thus ensuring that the products are safe for their intended applications before being placed on the market.
For both directives, it is the manufacturer’s legal responsibility to verify that their product complies with the applicable directive(s) before placing the CE mark on it and selling it in the EEA by having a Notified Body certify conformity to the applicable directive(s). This involves having a proper product design and proper documentary evidence (i.e. test reports, etc.) to show that the product complies with all relevant criteria in the given directive(s). INSPECCO assists manufacturers in ensuring that they have all the required documents and technical requirements – upon successful completion of this, a certificate is issued to the manufacturer.
Why choose INSPECCO for these services?
As a global solution partner of the Turkish Standards Institute (TSE), NANDO Notified Body Number 1783, INSPECCO is authorized to perform CE marking services on all types of medical devices and in vitro diagnostic equipment according to the Medical Devices Directive and the In Vitro Diagnostic Medical Devices Directive.
How to apply or learn more?
For more information, a free quotation, or to apply, you can contact us via the contact form below.