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EU Regulations Recap

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EU Regulation Recap: Clinical Evaluations And Performance Studies

In what way are the EU requirements for clinical evaluations and clinical investigations for medical devices changing under the Medical Devices Regulation compared with the current medical device directives? Here’s a look at Chapter VI of the impending MDR.

Europe Regulation Medical Device

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EU Regulation Recap: Classification & Conformity Assessment In Chapter V

What will happen when there is a dispute over which risk class a product falls into under the future Medical Device and IVD Regulations? How does the scrutiny process differ for medical devices and IVDs? Here we detail chapter V of the future regulations, which addresses these and other classification and conformity-assessment issues.

Europe Policy & Regulation

EU Regulation Recap: Chapter V Demonstrates Conformity Assessment Routes For Each Risk Class

What procedures will manufacturers need to follow to comply with the future medical device and IVD regulations, and when will a notified body need to be involved? A look at these issues as addressed in the fifth chapter of the pending regulatory documents.

Europe Policy & Regulation

EU Regulation Recap: Notified Bodies, Chapter IV

How can you be sure that your notified body is operating fairly and to a high standard? How long can your products remain on the market if your notified body’s operations are suspended or simply cease? Chapter IV of the forthcoming Medical Device and IVD Regulations details requirements for notified bodies as well as the process for their designation and monitoring.

Europe Regulation

EU Regulation Recap: Traceability and UDI, Registration, Eudamed, And More From MDR/IVDR Chapter III

The third chapters of the Medical Devices Regulation and IVD Regulation are substantially similar in addressing UDI, and also in dealing with subjects surrounding device identification and traceability; registration of devices and of economic operators; summary of safety and clinical performance; and the European databank on medical devices (Eudamed). This is the latest in our series of articles delving into the MDR and IVDR, chapter-by-chapter.

Regulation Europe

EU Regulation Recap: IVDR Chapter II – Economic Operators, Reprocessing, CE-Marking And Free Movement

In the third article of a series that takes a deep dive into the EU's forthcoming Medical Device and IVD Regulations, Medtech Insight focuses on the second chapter of the IVD regulatory text. This chapter looks at the making available and putting into services of devices, obligations of economic operators, reprocessing, CE-marking and free movement.

In Vitro Diagnostics Regulation

EU Regulation Recap: Economic Operators, Reprocessing, CE Marking And Free Movement

A detailed look at the second of 10 chapters of the new EU Medical Devices Regulation, which is pending final adoption. The chapter focuses on the making available and putting devices into service, obligations of economic operators, reprocessing, CE marking and free movement. Part of an ongoing series.

Europe Medical Device

EU Regulation Recap: A Look At Scope And Definitions In New EU Rules

The EU takes a breather over its summer months after an intense period of discussion about the future Medical Device and IVD Regulations. Taking a broad overview of the new regulatory texts, what do we know about the key changes they will bring? This piece looks at the most noteworthy elements of the MDR and IVDR scope and definitions sections. Look for recaps of other sections in the weeks ahead.

Regulation Europe

The New EU Regulations: A Guide To The Texts

Where do you find the information you are looking for in the new EU Medical Device and IVD Regulations? After so many changes have been made, we provide you here with the structures of the MDR and IVDR at a glance.

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