EU Medical Device Regulation Testing

Navigate complexities of the European Union’s Medical Device Regulation (MDR) compliance requirements with confidence. Element provides comprehensive testing and certification services to medical device manufacturers looking to sell their products within the EU. Our expertise ensures full compliance and our global network of local specialists support manufacturers navigating the changes from the Medical Device Directive (MDD) to MDR – while accelerating your path to market through streamlined testing and documentation.

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What is EU Medical Device Regulation Testing at Element?

The EU Medical Device Regulation is a mandatory step in the CE Marking process for medical products ranging from wheelchairs to bandages to diagnostic equipment. The MDR exists to ensure that all devices in the European Union are safe and operate without defect.

Our Medical device testing services provide you with the test data you need to demonstrate conformity with the Medical Device Regulation. We can support all your testing needs, including safety, EMC and wireless from one trusted provider.

Element testing technician holding SAR head phantom for mobile phone radiation testing and certification

What Can Element Offer You For EU Medical Device Regulatory Testing?

Key Tests Offered

At Element, we provide comprehensive electrical safety testing solutions including

IEC 60601 electrical safety testing and certification

IEC 60601 EMC testing and certification

Wireless medical device testing

Risk management, useability and software documentation review

Cyber security testing and documentation review

Technical file compilation support

Test plan generation and support

CE marking support.

ASCA and NRTL for North America

Training and support

Products We Test

Element tests a wide range of medical devices with specialized expertise in electrical medical equipment.

We offer a full suite of testing for a wide range of medical devices, including Electrical Safety, EMC, Radio, Cyber Security, Software, Risk Management & Useability. Medical devices we test include (but not limited to):

Home Healthcare

Alarms

Diagnostic Equipment

Nerve Stimulation

Implantable Devices

Endoscopes

Sterilisation

Which Labs Offer This Service

Our global network of medical testing laboratories across the world, providing global access to our end-to-end capabilities. Explore all our labs on our Locations Page.

Market Entry and Acceleration

Significantly reduce test costs and time to market with our support as a Certification Body Test Laboratory (CBTL), a Nationally Recognized Test Laboratory (NRTL) and National Certification Body (NCB) under the IECEE scheme. Our Global Market Access team provides expert guidance on electrical safety requirements across different regions, helping you navigate varying regulatory landscapes while maintaining consistent compliance standards.

Certification Advisory Services

We provide specialized electrical safety, EMC and radio certification advisory services to guide you through testing and approval requirements for your medical devices. We support through test plans, regulatory guidance across multiple directives (EMC, RED, LVD, NRTL, ASCA, FDA), training and ongoing documentation review. We issue documentation in formats specifically recognized by enforcement authorities to ensure successful product launches.

Standards we test to and products we test

These are our most prevalent requests. Don't see what you're looking for? Contact us!

We test to a wide range of standards that support compliance of medical devices around the world, including many of the IEC 60601series. This includes electrical safety, EMC, radio, cyber security, software, useability, risk management, RoHS, REACH and more.

Your Challenges, Our Solutions

Compliance Complexity

We provide complete end-to-end support for electrical safety testing and CE and UKCA Marking, with expert guidance on IEC 60601-1 compliance and mandatory ISO 14971 risk management documentation.

Speed to Market Pressure

Our streamlined testing process and single-supplier approach accelerates your path to market while maintaining compliance and quality standards.

Documentation Burden

Our experts handle all technical documentation needs, ensuring presumption of conformity through comprehensive Technical Files and Declaration of Conformity. We produce documentation in formats specifically recognized by enforcement authorities throughout the EU.

Global Market Access

As both a CBTL and NCB under the IECEE scheme, we simplify worldwide certification challenges with our dedicated Global Market Access team. We are also a recognized NRTL test laboratory and certification body under IEC 60601 for the USA and Canada.

Why Choose Element

Element test engineer setting up equipment in RF testing chamber

Global Market Access

Our global network of medical device specialists support manufacturers across all major markets, providing a simple one-stop-shop solution for North America, Europe and Asia.

Comprehensive Testing

Single-source supplier for impartial third-party support in all aspects of the MDR, CE and UKCA Marking, from compliance planning through to final certification.

Expert Support

Access to connected medical device experts across multiple continents for specialized guidance on regulatory requirements for a particular product.

Guidance For Changing Standards

Our experts help determine how any new legislation will affect your products and what you must do to remain compliant.

Frequently asked questions

What aspects of the MDR are mandatory before CE Marking can take place?

Key mandatory aspects include:

Product Safety Testing to show presumption of conformity to the essential requirements of the LVD
Compilation of a Technical File
Completion of a Declaration of Conformity (DoC)

How does the 2020 MDR change affect medical device certification?

The 2020 MDR (Medical Device Regulation) significantly alters medical device certification in the EU, introducing stricter requirements and a phased transition period. While existing certificates under previous directives (MDD and AIMDD) are valid until May 2024, all new devices placed on the market after May 26, 2021, must comply with the MDR. This includes recertification of legacy devices.

What are the consequences of incorrect CE marking?

Incorrect CE marking carries severe penalties for both companies and individuals responsible for signing the Declaration of Conformity.

Why is ISO 14971 important for electrical safety testing?

ISO 14971 provides a structured process for identifying, assessing and controlling risks, including those related to electricity. It is the international standard for Application of Risk Management to Medical Devices is a mandatory requirement for demonstrating compliance with EN/IEC 60601-1.

What risk management support do you provide for ISO 14971?

We offer comprehensive support including bespoke one-to-one training, documentation and procedure review, support with production of essential documentation, plus mentoring and retainer contracts to ensure ongoing compliance.

Explore our global network of labs and find your nearest location

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