Thanks to Kiwa expertise, Medical Companies can demonstrate effective compliance with requirements related to the products and can access to the European market, as well as obtaining prerequisites to access to other global markets. Moreover, thanks to Kiwa technical expertise, medical devices manufacturers can rely on a trusted partner, able to guarantee the execution of an effective conformity assessment process, which can combine the guarantee of market safeguard with the business tool.
Notified Body role
Through the notification of Kiwa Italy (N.B.0476) and Kiwa Turkey (N.B.1984), Kiwa is able to provide globally conformity assessment services for CE marking in compliance with 93/42/EEC directive and subsequent amendments.
Kiwa operates by statute in an independent, objective and impartial way during conformity assessment activities, ensuring high levels of competence, professionalism and absolute integrity of its professionals, in order not to influence in any way the evaluation or results of the CE marking process. Furthermore, Kiwa created internal procedures useful to guarantee the absolute confidentiality of the information received during the evaluation activities.
Through the association with the NB team (European association of Notified Bodies in the medical devices field) Kiwa has quick access to all the updated information and to the new approaches applicable to medical devices. Kiwa actively participates in technical working tables for the development of the main documents and the main guidelines for the medical sector.
Conformity assessment procedure for Medical Devices
The procedure to follow to obtain the CE Mark can be different depending on the risk of the medical device and it needs to meet the essential requirements defined by 93/42/EEC and subsequent amendments.
Regarding the Class I medical devices, manufacturers can independently proceed with product certification, measurement devices and devices placed on the market as sterile excluded. Those cases require the intervention of the Notified Body, limited to the metrological aspects and the maintenance of sterility.
For Class IIa, Class IIb and Class III devices, Notified Body’s conformity assessment is always required. The NB needs to effectuate the conformity assessment and evaluate the technical documentation related to the product and to the quality system applied by the manufacturer.
After defining the certification process, the manufacturer has to submit the request to Kiwa using the specific form.
Kiwa will evaluate the feasibility of the request and will confirm the certification process to be followed, normally composed of the following steps:
- Initial Study - evaluation of manufacturer’s application requests and identification of all the necessary actions and conformity evaluation route to start with CE certification.
- Documental Analysis – evaluation of the whole technical documentation of the medical device, related quality management system procedures included and, if applicable, the design dossier.
- On-site Audit for initial certification - evaluation of quality system assessed during the documental analysis applied to product lifecycle: concept, design, production, final control and post-market surveillance.
- Issue of CE Certificate - issuance of the CE Certificate following the positive results obtained by documental analysis and onsite audit.
- On-site Audit for the maintenance of the certification - annual assessment to guarantee continuous fulfillment of the requirements of the Medical Devices Directive.
- Unannounced Audits - on-site audits that, following the European Commission Recommendation 2013/473/EU, of 24 September 2013, shall be carried out at any time, in addition to the periodical ones, both at the manufacturer's site and at critical suppliers production sites, to verify the day to day compliance with legal obligations.
Kiwa provides also the following related services:
- Quality Management System Certification according to the main referenced international standards (ISO 13485, ISO 9001,... ) as accredited Certification Body.
- Electrical safety, electromagnetic compatibility and any functional test with respect to the harmonized Standards.