^{Published on 13.1.2026}

^‍Bringing a medical device to international markets is a strategic process that combines regulatory expertise, risk management, and market insight. The two most critical regulatory frameworks are the EU’s MDR legislation and the U.S. FDA approval process. Alongside these, various national and voluntary certification requirements may influence medical solutions’ approval and commercialization.   

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Overview of IEC 60601-1 as the central medical device standard

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EU: MDR and Notified Body collaboration   

In the EU, medical devices fall under the Medical Device Regulation (MDR). The approval process depends on the device’s risk class:   

• Class I (low-risk devices): Manufacturer’s self-declaration of conformity is often sufficient with a few exceptions.
  

• Device is placed on the market in sterile condition.

• Device has a measuring function.

• The device is a reusable surgical instrument.
  

• Class IIa, IIb, and III: Require assessment by a Notified Body (NB), including review of the quality management system of the company and technical file of the product.

It’s easy to mix up the roles of a Notified Body (NB) and an accredited test laboratory. Here are the differences.

• A Notified Body checks compliance with EU laws, such as the Medical Device Regulation (MDR). They do this by auditing the manufacturer and reviewing the product’s technical documentation.

• An accredited test laboratory verifies that production-equivalent prototypes meet the relevant standards.

You can request a test laboratory to perform testing against:

• EN standards (for EU markets), or

• IEC international standards (for broader global markets), following IEC Test Report Forms (TRF), or

• product-specific requirements.

To begin, you can visit the official EU webpage for regulations and harmonized standards.

Beyond compliance testing against EU regulations, there are additional voluntary certifications.

For example, SGS and Eurofins offer IECEE CB Scheme certification, which addresses national differences in IEC standards across 50+ countries. This is an efficient way to build a global approval strategy.

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Blog: What happens when a medical device has no particular standard?

USA: FDA, FCC, and NRTL requirements   

In the U.S., medical device approval is overseen by the FDA (Food and Drug Administration). The pathway depends on the device class:   

• Class I: Low risk devices are often exempt from premarket notification [510(k)] requirements, but the device and, e.g., manufacturing practices and followed quality standards shall comply with fundamental FDA requirements.   

• Class II: Typically goes through the 510(k) premarket notification pathway I, demonstrating “substantial equivalence” to a legally marketed predicate device.   

• Class III: High-risk medical devices require a comprehensive PMA (Premarket Approval) process.   

• Class I / Class II:  Novel, low-to-moderate-risk medical devices with no existing predicate device for comparison may undergo De Novo pathway.

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U.S. Regulatory overview for electrical and medical devices

For medical electrical equipment, applicable safety standards include ANSI/AAMI 60601-1 or IEC 60601-1 with U.S. national deviations.

FCC regulates radio frequency (RF) and electromagnetic compatibility (EMC) for electronic devices. Medical devices typically follow IEC 60601-1-2 and CISPR 11 standards. FCC-certified RF products must display an FCC ID.

OSHA requires electrical equipment used in workplaces to comply with safety laws. Nationally Recognized Testing Laboratories (NRTL) verify compliance and often provide a certification mark to show products meet standards for fire safety and electrical safety.

NRTL certification can be obtained from organizations approved by OSHA for third-party product safety certification.

Strategic planning from the start   

Approval strategy should be integrated early in product development. Key steps include:   

• Defining the intended use. 

• Qualifying the device as medical device. 

• Defining the medical device classification.

• Understanding when self-declaration is sufficient and when external assessment is required. 

• Creating technical documentation for the designed device.

• Identifying applicable standards and defining a strategy to show compliance with standard requirements.

• Choosing testing and certification partners based on target markets. 

• Establishing Quality Management System applicable to the device.

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Turning complexity into competitive advantage   

While approval processes may seem complex, they offer an opportunity to build trust and competitive edge. A well-planned strategy can accelerate market entry and reduce risks and collaboration between marketing and regulatory teams sets up a solid base to the solutions’ long-term success.

If you are considering a partnership to support this phase of development, we encourage you to leave a descriptive contact form. We can map out what you need for successful market entry and get back to you shortly. You may also continue to explore our product development and quality and regulatory offering.