How do I get my medical device certified?

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

Once revceived the offical 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 confomity assessment activities can start.

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.

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.

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).

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. 

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

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. 

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.