What is a conformity assessment procedure?
In principle, medical devices are required to carry a CE mark before being initially placed on the European Economic market. The CE-marked medical device has to fulfil the essential requirements of the European medical device legislation on safety, performance and innocuousness to human health and this has to be documented in writing as part of the conformity assessment procedure. The conformity assessment procedure and its implementation are set out in the Medical Devices Regulation (MPV), which refers to the relevant annexes of the European directives. Depending on the risk classification of the product to which conformity is assessed and verified by the manufacturer or by involving a Notified Body.
The type of conformity assessment procedure to be conducted and the extent to which an independent testing and certification body (Notified Body) is required, depends on the potential risk associated with the products. While no distinction is made between active implantable medical devices according to risk levels, Directive 93/42/EEC (MDD) provides for a differentiation of devices into 4 product classes (I, IIa, IIb, III). The classification and the choice of conformity assessment procedure to be applied to a product result from the criteria set out in Annex IX of Directive 93/42/EEC.
Notified bodies carry out the prescribed inspections and issue the required certificates. Manufacturers can approach any notified body of their choice, which is accredited for the relevant procedure and the appropriate product category. DQS MED is a Notified Body (identification number 0297) of the European Union and as such is authorized to perform conformity assessment according to EU directives that are mandatory to all products imported into the EU. We carry out conformity assessment procedures subject to Annexes II, V and VI of the Medical Device Directive and examine the technical documentation towards the requirements of Directive 93/42/EEC
Why CE certification for medical products?
CE certification of medical devices by the DQS MED allows you, together with the necessary examinations proving compliance of your medical devices, to further exploit potentials in existing markets and to enter into new national and international markets. Additionally beyond that, risks and liability obligations in your chosen markets will be weakened.
Who is affected by CE certifications for medical devices?
Before you place a medical device on the European market or operate your medical devices, it must bear the CE marking. Medical device refers to an object or substance which is used for medical, therapeutic or diagnostic purposes in human beings and which, in contrast to drugs, the principal intended action primarily is not achieved by pharmacological, metabolical or immunological, but through physical or physico-chemicall means. The CE marking is not a quality mark nor is it intended for consumers. It is a legally binding statement by the manufacturer that his product meets all requirements of the Medical Device Directive 93/42/EEC.
How does CE certification for medical products take place?
What benefit has a CE certification of medical devices?
CE certification of medical devices by the DQS MED allows you, together with the necessary examinations proving compliance of your medical devices, to further exploit potentials in existing markets and to enter into new national and international markets. Through the approval you will gain a clear competitive advantage. Additionally beyond that, risks and liability obligations in your chosen markets will be weakened.