Medical Device Regulation (MDR)

Medical devices manufactured or traded in the EU must comply with EU legislation in the area of safety and health. This means they have to be conform to the pertaining product directives and must be CE marked. New European legislation, the Medical Device Regulation (MDR), has taken effect per May 2021. The EU adopted the MDR following scandals caused by a number of medical device manufacturers. Kiwa is a Notified Body for MDR certification. Read more in this section about the MDR and how we can help you with MDR certification.

Kiwa Medical Device Certification

Your partner for MDR and ISO 13485 certification

Medical devices placed on the European market must comply with the Medical Device Regulation (EU) 2017/745 (MDR). This regulation ensures that devices meet high standards of safety and performance. As a manufacturer, obtaining CE marking is essential for market access. Kiwa Assurance B.V., operating under the name Kiwa Medical Certification, is a designated Notified Body (NB 1912) under MDR and an accredited certification body for EN-ISO 13485:2016 quality management systems.

Impartiality and independence

We are financially self-sufficient and earn our income exclusively from the services we provide to our clients. Our standard fees are publicly available here. Together, these factors ensure that our certification activities remain free from any commercial, financial or other influences that could affect our impartiality.

MDR and ISO 13485 Certification

Kiwa Assurance B.V. offers MDR conformity assessment, EN-ISO 13485 certification and accredited testing for medical devices. Our designation and accreditations cover a broad scope, with routes for both QMS-based and design- or product-based assessments. With experienced auditors, reviewers and engineers, we support manufacturers throughout their certification and testing processes.

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.

Medical Devices Regulation

The Medical Device Regulation (MDR) has replaced the Medical Devices Directive (MDD). Kiwa Dare has been designated as notified bodies for the MDR.

Medical Devices Directive

The Medical Devices Directive (MDD) has taken effect in 1993, and has been revised in 2010. The MDR (EU 2017/745) has replaced the MDD.

Kiwa Notified Body for medical devices

Kiwa Assurance B.V. is a Notified Body for medical devices. We assess whether medical devices meet the legally established requirements of the Medical Device Regulation (MDR).

Transition period

The MDR became fully applicable on 26 May 2021, replacing the previous Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD). While certain legacy devices certified under the MDD may still be placed on the market during the extended transition period, the MDR is now the primary regulatory framework for all new medical device certifications in the EU.

Under Regulation (EU) 2023/607, the transition period has been extended as follows:

  • Until 31 December 2027 for:
    • Class III and Class IIb implantable devices (except certain well-established technologies)

  • Until 31 December 2028 for:
    • Class IIb (non-implantable), Class IIa, and Class I devices that require Notified Body involvement under MDR
  • These extensions apply only if specific conditions are met, including:
    • The device continues to comply with the MDD or AIMDD
    • No significant changes are made to the design or intended purpose
    • The manufacturer has implemented a compliant Quality Management System (QMS)
    • The manufacturer has submitted a formal application for MDR certification to a Notified Body by 26 May 2024 and signed a written agreement by 26 September 2024.

After these dates, devices not certified under MDR or not meeting the transitional conditions can no longer be placed on the EU market.

Certification information and requests

Upon request, we can provide:

  • Information on issued certificates
  • Certification status of organizations
  • Scope and location of certified clients
  • Geographic areas of certification activity

For inquiries, contact us at  nl.nboffice@kiwa.com.

Useful links

Contact

If you have any questions about the Medical Device Regulation (MDR), please contact for more information Medical Devices, Kiwa Netherlands.

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