Medical device certification

Testing and certification to international safety standards

Electrical medical devices must be safe for both the user and the patient. With medical device certification you give patients and medical professionals assurance of the safety and effectiveness of your products. Have your products tested at DEKRA's accredited laboratories to demonstrate that your products comply with strict standards and regulations that apply to medical devices.

IEC 60601 is one of the most important standards for the certification of medical devices. This international standard contains a set of technical requirements for the safety and essential performance of electrical medical devices. In most markets it is mandatory to comply with this widely accepted standard.

Medical device certification by DEKRA allows you to demonstrate that your medical device meets all safety requirements. Curious about our accredited scope for medical device testing?

View scope (PDF, 90 KB)

Why certify through an accredited lab?

Medical device certification in 7 steps

The medical equipment certification process

DEKRA is your partner for medical device certification. As a manufacturer or designer, you know your product best. We know the medical device standards in detail. For almost 100 years, DEKRA has been one of the largest players worldwide in the field of testing and inspection. In addition, our experts have years of experience in medical equipment certification. At DEKRA, you are assured of a reliable and fast process.

Optional next steps

Getting your medical electrical equipment certified for access to global markets is no easy task. We guide you through the certification process from start to finish in each of the seven steps. After your device or product has been certified by DEKRA, the following steps may also be necessary:

Notified Body

Obtain regulatory approval through DEKRA's Notified Body. Please note that regulatory approval may run in parallel with our compliance testing procedure for safety and EMC & Wireless testing.

International medical device certifications

Our experts help you reach new and emerging markets worldwide. For example, if you want to sell your medical electrical devices in the US or Canada, our NRTL accredited laboratory is ready to help you with your CB certification for the North American market, cDEKRAus product certification mark, INMETRO certification requirements and more..

View product testing certificates

DEKRA Mark

DEKRA Mark is a quality mark that shows that your product has been thoroughly tested and meets all required safety standards. Since DEKRA's quality mark is based on internationally recognized standards, a medical device security certification is your passport to worldwide access for your product.

More about DEKRA Mark

Benefits of medical equipment certification through DEKRA

Accredited Test Laboratorium (CBTL)

Our testing laboratory in Arnhem is accredited by the Dutch Accreditation Council (RvA). You can be sure that we have extremely high standards for the work of our technicians, our reports and project management. Besides our laboratory in Arnhem, we have several laboratories worldwide that you can visit when needed. Medical device certification at DEKRA is possible all over the world.

Centralized approach

DEKRA's extensive portfolio allows you to entrust all your testing procedures to one partner. With this centralized approach you benefit from:

a central point of contact;
fast communications lines;
minimal transportation of samples;
openness about non-conformity;
an extremely short time-to-market.

Extensive scope

We provide support for ISO 17025 safety standards and CB certification. If required, we can expand the scope on the basis of long-term cooperation. Take advantage of a free session with one of our experts to discuss your specific medical equipment certification needs. Request a session

Certification programs for various markets

Are you planning to introduce your product to the US or Canadian market? We are accredited as a Nationally Recognized Testing Laboratory (NRTL) based on our cDEKRAus quality mark. In other words: we take care of you from A to Z. View an overview of all product certificates

Focus on partnership

We assist our customers throughout the entire medical device certification process. This results in a relationship characterized by mutual trust, openness and reliability.

EMC and cybersecurity

Our state-of-the-art laboratory in Arnhem offers extensive testing options in the field of electromagnetic compatibility (EMC) and cybersecurity.

Take the first step towards certification

Get in touch with an expert

Medical device certification FAQs

What technical documentation is prepared for my certification?

When preparing technical documentation for compliance with the essential performance requirements of Directive 93/42/EEC (MDR), we check whether medical devices meet the criteria of:

IEC/EN 60601 (standards for electrical medical equipment)
IEC 62304 (Lifecycle of medical device software)
IEC 62366 (usability of medical devices)
ISO 14971 (risk management for medical devices)

How can I prevent non-conformity?

How much does medical device certification cost?