eIFU Requirements Under the MDR
The Medical Device Regulation (MDR) introduces a comprehensive framework that integrates multiple electronic instructions for use (eIFU) requirements, further supplemented…
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EU Regulatory Importer: Legal Liabilities & Considerations
Manufacturers of Medical Devices and In Vitro Diagnostics (IVDs) located outside the European Union (EU) are required to appoint an…
EU MDR Risk Classification: Guide and Case Study
Manufacturers are responsible for determining…
Annex II Under the MDR: What is a Technical File?
This article draws from our experience in conducting Tech-File reviews and outlines the key requirements for Technical Files based…
Clinical Investigation Under the MDR: When is it Not Mandatory?
Due to the resources necessary to perform a clinical investigation under the…
Performing Clinical Evaluations: Article 61(10) Under the MDR
Under Article 61(10) of the MDR,…
EUDAMED User Guide: SSCPs and Certificates
The European Commission published the updated EUDAMED User Guide – Notified Bodies & Certificates…
MHRA Guidance on SaMDs: Navigating the Regulatory Landscape
Software as a Medical Device (SaMD) is defined as software intended to be used for one or more medical purposes…
Medical Device Stand-Alone Software Under the UK MHRA
Following a trend…
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