Certification of active medical equipment and software
Medical Device Regulation
Medical Device Regulation (MDR) & ISO 13485 Certification
Please Note: Our website has moved! All up-to-date information regarding our medical device testing, certification, and application procedures can now be found on our central Kiwa website.
👉 Visit our updated Medical Device Regulation (MDR) page here
About Our Medical Certification Services
Kiwa Assurance B.V. remains your dedicated, designated Notified Body for the Medical Device Regulation (MDR). We specialize in performing conformity assessments for active non-implantable medical devices.Â
Whether you are looking to certify a single batch or a large portfolio of products, our team of lead-auditors, technical documentation reviewers, and internal clinicians are ready to support your route to CE marking.
Our core services include:
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MDR Conformity Assessments: We support manufacturers in obtaining CE-marking through product verification (MDR Annex X and XIB) or combined assessments of your quality management system and technical documentation (MDR Annex IX or XIA).
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EN-ISO 13485:2016 Certification: As an accredited body (RvA system certification - C637), we offer Quality Management System assessments. These can be performed as a standalone service or seamlessly combined with your MDR Annex IX / XIA audits.
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Medical Device Testing: Our experienced engineers conduct EMC and safety testing in accordance with the EN-IEC 60601 standard.
Ready to take the next step?
For current brochures, detailed application procedures, impartial information, and to get in touch with our medical devices team, please navigate to our new home:
