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Medical Device Manufacturers

Independent expertise for safe medical devices and reliable market access

Medical device manufacturers operate in a highly regulated and rapidly evolving technological environment. New technologies, software, connectivity and digitalization are creating new opportunities for diagnosis, treatment and patient care. At the same time, requirements relating to safety, performance, quality management, cybersecurity and technical documentation are becoming increasingly complex.

In the Netherlands, DEKRA supports medical device manufacturers with independent conformity assessment, certification and product testing. Our expertise includes the Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), ISO 13485 and the testing of medical electrical equipment against relevant international standards.
DEKRA is designated in the Netherlands as Notified Body under both the MDR and IVDR. Manufacturers can also benefit from DEKRA's expertise in product safety, EMC, software, usability, cybersecurity and international market access.
By considering certification and product testing early in the development and market access process, manufacturers can identify relevant requirements in time, reduce technical risks and work more efficiently towards successful conformity assessment.
How DEKRA supports medical device manufacturers
Regulatory expertise

Medical devices must comply with extensive legal and technical requirements before they can be placed on the market. DEKRA independently assesses medical devices and quality management systems against applicable European regulations and international standards.

Product safety and performance

Safety and essential performance must be demonstrably controlled throughout the development of a medical device. DEKRA tests medical equipment in areas including electrical and mechanical safety, electromagnetic compatibility and other relevant product requirements.

Quality management

An effective quality management system is an important part of controlling the entire lifecycle of a medical device. DEKRA certifies organizations according to ISO 13485 and assesses whether relevant processes for areas such as design, manufacturing and quality assurance are systematically established and controlled.

One organization for testing and certification

Manufacturers often have to deal with multiple standards, testing programs and certification activities. Within DEKRA, conformity assessment, management system certification and various technical testing activities can be combined. This provides manufacturers with a coordinated route towards compliance and market access.

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Our approach

The requirements applicable to a medical device depend on factors including its classification, intended use, technology and the market in which the product will be introduced.

From product development to market access

It is therefore important to determine at an early stage which regulations, standards and testing activities apply. DEKRA supports manufacturers during different stages of the development and certification process with independent assessments and testing. Identifying the relevant requirements and testing activities at an early stage can help manufacturers reduce the risk of non-conformities, additional testing and delays later in the process.
Depending on the product and required scope, our services may include:
EMC testing

Electromagnetic Compatibility Testing (EMC)

Laboratory and on-site compatibility testing to determine the compliance of electronic components and products with regulatory electromagnetic standards.
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Global market access service logistic options

Global Market Access service

Meet technical regulations with certifications and approvals so your organization can easily enter global markets.
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Medical equipment according to IEC 60601

IEC 60601 standard

The international IEC 60601 standard for the safety and performance requirements for electrical medical devices. Does your medical equipment comply with the latest IEC 60601 laws and regulations?
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ISO 13485 certification

ISO 13485 certification

ISO 13485 is an internationally recognized and harmonized Quality Management System (QMS) standard. It is developed for medical device manufacturers and describes a process approach in terms of the design, safety and quality.
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IVDR

IVDR

Notified-body medical device certification for in-vitro diagnostic products according to regulatory requirements mandated by European and international norms.
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MDR regulation

Medical Device Regulation (MDR)

Regulatory certification for medical devices subject to the strictest quality, reliability and safety compliance standards to protect public and private health.
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lock on a motherboard

Penetration Testing

Penetration testing is a simulation of cyberattacks on your systems to evaluate the effectiveness of your security measures and identify any vulnerabilities.
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Certification and marks

Product certification and marks for products

Recognized distinctions with industry certifications and regulatory marks demonstrating product safety, performance and quality standards in global markets.
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RED directive eu

RED Directive testing

You must comply with the Delegated Act of the Radio Equipment Directive (RED) from August 2025. Read more about future legislation and how DEKRA can help you here.
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Electrical safety

Safety Testing for Electrical Products

Assurance testing to substantiate the safety and regulatory compliance of electrical products for increased confidence and higher profits in global markets.
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Product optimization and performance tests

Usability and performance testing

Functionality, flexibility and accessibility testing to ensure the optimal usability and high performance of products developed for specific consumer needs.
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Wireless testing

Wireless testing

Capability testing to prove wireless components and devices using radio frequency interfaces meet functional requirements and comply with regulatory standards.
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Relevant services for medical device manufacturers

  • MDR conformity assessment
    The Medical Device Regulation (EU) 2017/745 establishes requirements for medical devices placed on the European market. For various risk classes, the involvement of a Notified Body is required.
    DEKRA is designated in the Netherlands as a Notified Body under the MDR. Depending on the device classification and selected conformity assessment route, DEKRA assesses areas including the manufacturer's quality management system and technical documentation to determine whether the applicable regulatory requirements are met.
    For devices requiring the involvement of a Notified Body, successful conformity assessment is an important step towards CE marking and access to the European market.
  • IVDR conformity assessment
    In vitro diagnostic medical devices are subject to the In Vitro Diagnostic Regulation (EU) 2017/746. The IVDR establishes requirements relating to areas including classification, performance, technical documentation, post-market surveillance and traceability.
    DEKRA is also designated as a Notified Body under the IVDR and can assess manufacturers within the scope of this designation.
  • ISO 13485
    ISO 13485 is the international standard for quality management systems within the medical device industry. The standard is relevant to organizations involved in different stages of the medical device lifecycle, including design, development, manufacturing and distribution.
    DEKRA is accredited by the Dutch Accreditation Council (RvA) for ISO 13485 certification. Certification provides independent evidence that an organization has systematically established and controls relevant quality processes.
    ISO 13485 certification can also be combined with other regulatory activities within DEKRA.
  • Electrical safety and IEC 60601
    For medical electrical equipment, the IEC 60601 series provides an important international framework for basic safety and essential performance.
    DEKRA tests and certifies medical electrical equipment against relevant parts of this series of standards. Depending on the product, different technical aspects can be assessed, including electrical safety, EMC and requirements related to the specific application of the equipment.
International market access
Many manufacturers develop medical devices for multiple international markets. However, certification and market access requirements vary between regions.
Through DEKRA's international network, manufacturers can access additional certification programs and expertise for different markets. Within its international organization, DEKRA offers services including MDR and IVDR certification, ISO 13485, MDSAP and UKCA services.
This enables manufacturers to better coordinate different market access activities and, where possible, benefit from an integrated approach to testing, auditing and certification.

Frequently Asked Questions

This depends on factors including the type of medical device, its risk classification and the selected conformity assessment route. For many medical devices in higher risk classes, the involvement of a Notified Body is required before CE marking can be applied. DEKRA Certification B.V. is Notified Body 0344 under the MDR and IVDR.
The exact assessment depends on the conformity assessment route and classification of the device. Depending on the situation, the assessment may include the quality management system, technical documentation and evidence demonstrating that the product meets the applicable safety and performance requirements.
The MDR is European legislation governing medical devices. ISO 13485 is an international standard for the quality management systems of organizations within the medical device industry.
ISO 13485 certification can support manufacturers in demonstrating effective control of their quality processes, but it does not replace a required MDR conformity assessment.
Yes. DEKRA provides product testing, ISO 13485 certification and regulatory conformity assessment. Which activities can be combined depends on the device, the required certification and the applicable requirements relating to independence and accreditation.
IEC 60601 is an internationally recognized series of standards addressing the basic safety and essential performance of medical electrical equipment. Test results against applicable parts of the series can provide important evidence for technical documentation and market access processes.
Medical equipment must operate safely and reliably in environments containing various electronic and wireless systems. EMC testing assesses, among other things, whether a device is sufficiently resistant to electromagnetic disturbances and whether it causes unacceptable interference itself.
A technically well-functioning medical device can still create risks if it is used incorrectly or is difficult to operate. Usability engineering helps manufacturers identify use-related risks and design products so they can be used safely and effectively by their intended users.
Not every medical device presents the same cybersecurity risks. For devices incorporating software, digital interfaces or network connectivity, however, cybersecurity can be an important part of the risk analysis and product assessment. As medical technology becomes increasingly connected, the importance of digital security continues to grow.
Yes. DEKRA has an international network and provides various services within the group to support global market access, including ISO 13485, MDSAP and UKCA certification. The appropriate route depends on the product and intended market.