MDR and ISO 13485 Certification

The MDR governs the placing on the market and use of medical devices and their accessories within the European Union and European Economic Area (EEA). It introduces more strict requirements for clinical evaluation, post-market surveillance and transparency across the device lifecycle.

Kiwa Assurance B.V. is designated by the Dutch Ministry of Health, Welfare and Sport (Dutch: Ministerie van Volksgezondheid, Welzijn en Sport) to perform conformity assessments under the MDR. Our designation covers a broad range of MDR codes, specifically for active (electronic) non-implantable medical devices. You can find our full scope in the NANDO database under NB 1912. 

We offer certification routes including:

• MDR Annex IX/Annex XI Part A (XIA):
  Conformity assessment based on a Quality Management System (QMS) and assessment of Technical Documentation. This route is typically used when the manufacturer wants to demonstrate compliance through a full system and documentation review.
• MDR Annex X/Annex XI Part B (XIB):
  Conformity assessment based on type examination and product verification. This route is used when the manufacturer opts for a design-based assessment (Annex X) and/or batch-by-batch product verification (Annex XI Part B), often for high-risk or limited-run devices.

Kiwa Assurance B.V. supports structured dialogue, promoting clear and efficient communication with manufacturers during the MDR conformity assessment process. Our experienced team of lead auditors, technical documentation reviewers, clinicians and support staff is ready to guide you through the certification process.

Source of information

• Application for MDR and/or EN-ISO 13485 certification

• Information package

Kiwa Assurance B.V. is accredited by the Dutch Accreditation Council (Dutch: Raad voor Accreditatie, RvA) under ISO/IEC 17021-1, with accreditation number C637. You can find our full scope on the website of the RvA. 

We provide:

• Standalone EN-ISO 13485 certification
• Combined EN-ISO 13485 and MDR certification

The standard ensures your quality management system meets international requirements for medical device manufacturing.

Source of information

• Application for MDR and/or EN-ISO 13485 certification
• Information package

Based on input from our customers, including innovative start-ups and small and medium-sized enterprises (SMEs), we are proudly introducing the MDR Start-up Support Program – designed to help medical innovators navigate the MDR with confidence.

Bringing a medical device to the market is exciting, but navigating the MDR can feel overwhelming. That’s where Kiwa Assurance steps in. We give innovative start-ups and SMEs the confidence and clarity they need to achieve CE marking effectively, so you can focus on what matters most: growing your business and delivering life-changing solutions.

What You’ll Get:

• Kick-off Intake & Pre-Application. We’ll map out your current status, challenges, and goals to set you up for a stress-free application process.
• Ready-to-Use Folder Structure & Checklists. No more guesswork. You’ll receive a practical folder system and clear checklists to organize technical documentation and your Quality Management System.
• Structured Dialogue & Roadmap. Stay ahead of requirements, avoid costly delays, and get answers to your questions early in the process. 

Why choose Kiwa Assurance?

Because every start‑up deserves a trusted guide to cut through regulatory complexity and accelerate market entry. With us, you’ll gain clarity, ensure compliance, and move forward with confidence.

As part of the structured dialogues (MDCG 2019-6) we can discuss the strategy of the clinical evaluation. If you want to know more Kiwa can review your clinical evaluation plan and indicate whether it is acceptable, specifying any unacceptable sections. This paid service is not providing solutions, but is aimed to support your process.

Limitations:

• The review is limited to the specified questions and does not constitute a full assessment of all relevant MDR requirements.
• The outcome of this partial review is non-binding. Since only part of the clinical evaluation is assessed, additional findings may arise during the main evaluation.

During the main evaluation, it may be necessary to consult an external clinical expert. Accelerate your path to MDR compliance and gain a competitive edge – partner with kiwa today and let our expertise help you bring your medical innovation to market with confidence.

Changing your MDR EU Notified Body or ISO 13485 Certification Body  can be complex, time‑critical, and risky if not handled properly. Our Seamless Transfer Program is specifically designed for medical device manufacturers who want to transfer from their current MDR Notified Body or Certification Body while maintaining full control over timelines, certification continuity, and communication.

We combine regulatory expertise with a structured, service driven approach to ensure a seamless and predictable transfer without interrupting your CE /ISO 13485 certification or market access.