Customer specific information

Welcome to the Kiwa Assurance B.V. customer information section, your central hub for accessing essential certification resources and maintaining clear communication throughout your certification journey. As part of our commitment to transparency and regulatory compliance under EU MDR (2017/745) and EN-ISO 13485:2016, we provide our clients with secure and structured access to key documentation and support tools.

Customer information section

This is your central hub for accessing essential certification resources and maintaining clear communication throughout your certification journey.

Information package

A comprehensive overview of our certification services, including process steps, timelines and documentation requirements.

Open the Information Package

Notification of Change form

Use this form to inform us of any substantial and/or notifiable changes to your organization, products or quality management system, as required under MDR and/or EN ISO 13485 (for certified clients only).

Download the form

Logos and use of certification marks

See here for our logos and the information package regarding the use of certification marks

Standard fees

We apply transparent pricing for all our certification and conformity assessment services. This includes MDR conformity assessments and EN ISO 13485 audits.

For details, please refer to our official Standard Price List.

Open the Standard Price List

Certification cycle information

For MDR CE marking, the standard certification cycle is up to 5 years (or shorter where appropriate, e.g. 3 years). This cycle includes ongoing surveillance audits and at least one unannounced audit during the period. For EN ISO 13485 certification, the standard certification cycle is 3 years, with annual surveillance audits and a recertification audit before certificate expiry.

Contact information

Direct access to our support team for answers with quotation requests, our MDR Start-up Support Program, process questions, documentation submissions or scheduling audits.

Certificate access and status

Upon request, clients can obtain:

• Copies of valid certificates issued

• Certification status of their organization

• Scope and location of certified activities

Validity of MDR certificates of Kiwa Assurance can also be checked on Eudamed.

Go to Eudamed

Geographical Areas of Operation

Kiwa Assurance B.V. provides certification and conformity assessment services for medical devices and quality management systems in accordance with the Medical Device Regulation (EU) 2017/745 and EN-ISO 13485:2016. Information about the geographical areas in which we operate is available upon request. Please contact us at nl.nboffice@kiwa.com for details.

Terms & Conditions and Kiwa regulations for Certification

For detailed information on our terms and conditions, as well as the Kiwa regulations for Certification, please visit:

Kiwa Terms & Conditions and Regulations

Appeal Process

If you disagree with a certification decision or the handling of a complaint, you can submit an appeal. Kiwa reviews all appeals carefully and independently to ensure fairness and transparency. Instructions for submitting an appeal are provided on the page linked above.

Please contact us immediately using one of the following methods:

Telephone: (+31) 348 200900
Email: Send the completed MIR form to vigilance@kiwa.com with “Vigilance” in the subject line.

When submitting your report, please include all relevant documentation, such as:

FSCA/FSN notices
Investigation details

For comprehensive guidance, refer to the accompanying information package.

All documentation and records are managed in accordance with ISO/IEC 17021-1, ensuring integrity, traceability and controlled access. We maintain strict confidentiality and data protection standards in line with regulatory and accreditation requirements.