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    • New European MDCG guidance clarifies designation of Notified Bodies under MDR, IVDR

      MDCG guidance on NB designation timeframes leave open capacity questions

    • US FDA: Nearly 700 breakthrough medical device designations since 2015

      FDA's Breakthrough Devices Program shows steady increase in designations

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MedTech

The medical device regulatory landscape is evolving. We help you bring safer products to markets worldwide and maintain compliance – even if your device is novel or high-risk.

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Our Expertise

Clinical research

Our team of experts has decades of experience in providing guidance on clinical evidence collection requirements, designing respective activities, and conducting medical device clinical studies to European requirements.

Post-market compliance

Regulatory compliance doesn’t end when your device goes to market. We design compliance solutions informed by a life-cycle approach to device safety and effectiveness.

Human factors research & design

Put a safer, more competitive device in the hands of patients and healthcare providers. Our human factors experts have deep expertise in medical device design.

Related News and Resources

The latest industry insights from our global team.

Regulatory Updates
New European MDCG guidance clarifies designation of Notified Bodies under MDR, IVDR

Fri Aug 12

Regulatory Updates
US FDA: Nearly 700 breakthrough medical device designations since 2015

Thu Aug 11

Regulatory Updates
US FDA releases draft guidance for conducting remote regulatory assessments

Fri Aug 05

Regulatory Updates
Japan’s MHLW updates online notification submission and package insert policies

Thu Aug 04

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© 2022 EMERGO by UL. All Rights Reserved. Privacy Terms of Use Data Subject Access Request Portal

Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality.