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EU MDR delay white paper
MDR One-year Delay: Implications for medical device manufacturers
In February 2020, the first European countries began to be affected by the COVID-19 virus. During March, the rest of the pack followed and Europe
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Understanding Europe's New Medical Device Regulation - MDR 2017/745
You've probably heard that Europe's well-established medical device regulations are about to change. And you probably have a lot of questions. What
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Understanding the EU IVDR white paper by Emergo by UL
Understanding Europe's New IVDR 2017/746
It's finally here. The European Commission's new In Vitro Diagnostic Regulation (IVDR 2017/746) will address several weaknesses of the IVDD and bring
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Understanding the EU IVDR white paper by Emergo by UL
IVD Medical Devices Clinical Performance Evaluation Studies
In Europe, certain in vitro diagnostic (IVD) devices must undergo clinical performance (CP) evaluation studies conducted in accordance with current
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EU IVDR Conformity Assessment Options for In Vitro Diagnostic Medical Devices
Beginning on May 26, 2022, new in vitro diagnostic (IVD) medical devices intended to be marketed in the European Union (EU) must comply with the In
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CE Marking Conformity Assessment for Medical Devices
Ready to sell your medical devices in Europe? First, you must comply with Europe’s medical device regulations. But instead of a one-size-fits-all
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Preparing a European CE Technical File for a Medical Device
Want to sell your medical device in Europe? If the answer is yes, you probably have a lot of questions about one of the key elements of the European
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Regulations for Companion Diagnostics in the US and EU
Are you marketing a companion diagnostics (CDx) product? If so, you already know two things: first, CDx products are powerful tools in precision
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Introduction to CE Marking for Medical Devices
Are you a medical device manufacturer with your eye on the European market? If so, you've probably heard the term "CE Mark". The CE Mark is the key
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