How do I get my medical device certified?
The procedure to obtain the CE Mark can be different depending on the risk class of the medical devices according to art. 52 of the (EU) 2017/745 Regulation.
For the Class I medical devices, other than custom-made or investigational devices, manufacturers can declare their conformity to MDR requirements issuing the EU declaration of conformity (art. 19, MDR) and independently proceed with CE Mark.
For Class I sterile devices (Is) or with measurement function (Im) or reusable surgical instruments (Ir), IIa, IIb and III (including custom-made implantable devices), the intervention of the Notified Body is always required. The activities that Kiwa can carry out for the conformity assessment are defined and described in Kiwa specific regulations.
Prior to place a device on the market, the manufacturer must choose the conformity assessment procedure to be followed and submit a pre-application to Kiwa using the specific form. Kiwa will evaluate the feasibility of the request in order to issue an offer that, once accepted, will represent the official application for the conformity assessment.
The process is usually composed of the following steps: