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:

The process

Pre-application activities and quotation

Kiwa examines manufacturer’s pre-application information in order to confirm the feasibility of the project and to issue the quotation.

Application review and contract

Once received the official application signed by the manufacturer (signed quotation), Kiwa makes the application review in order to accept or to refuse the project. The outcome of each review will be documented and sent to the manufacturer. 

Only if Kiwa's outcome is positive, the conformity assessment activities can start.

Documental Analysis

Kiwa evaluates of the whole technical documentation, including pre-clinical and clinical data, as well as related QMS procedures of the medical device, according to both the MDR chapters II and III, and the relevant conformity assessment annex chosen.

Specific procedures

For certain types of medical devices, as reported in art. 52 and 54 of the MDR, Kiwa carries out specific procedures referred to relevant sections of conformity assessment annexes chosen.

On-site Audit for initial certification

Kiwa evaluates the application to product lifecycle of the quality management system assessed during the documental analysis to ensure that the devices covered conform to the relevant provisions of the MDR (concept, design, production, final control and post-market surveillance).

Final review, decision and certification

Kiwa issues the EU Certificate following the positive results obtained by the final review and the decision making of all the conformity assessment activities carried out. 

On-site Audit for surveillance and post-certification monitoring

Annual assessment to guarantee continuous fulfillment of the requirements of the Medical Devices Regulation.

Unannounced Audits

Kiwa carries out on-site audits without prior notice, at least once every 5 years, in addition to the surveillance audits; those audits will be conducted at the manufacturer's premises and, where applicable, at critical suppliers ones to verify the day to day compliance with legal obligations.

During the audits also tests on the medical device are conducted. 

Recertification

Re-certification of approved QMS and EU technical documentation assessment certificate shall occur at least every five years. The manufacturer has to send to Kiwa a new pre-application request, including a summary of changes and scientific findings for the device, in order to start the re-certification activities.

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