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Tag: European Medical Device Regulations

RF Medical Completed the Transition to European Medical Device Regulations (MDR) for Class IIb Medical Devices | BioSpace

SEOUL, South Korea, Oct. 24, 2023 /PRNewswire/ -- RF Medical, specializing in the treatment of tumors and veins with various radiofrequency ablation products, announced today...

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MDCG Guidance on CABs and NBs: Notification and Publication

The article provides additional details regarding the matters related to the notification made in the context of designation and the appropriate publication. ...

MDCG Guidance on CABs and NBs: Decision on Designation

The new article describes the way the designating authority will take its decision on the designation of an applicant entity.  Table...

MDCG Guidance on CABs and NBs: Post On-Site Assessment Activities

The new article describes the actions to be taken by the parties involved upon completion of an on-site assessment.  Table of...

MDCG Guidance on CABs and NBs: On-site Assessment Activities

The new article provides additional details regarding the on-site inspection activities to be undertaken as a part of the designation process.  ...

MDCG Guidance on CABs and NBs: Application Review and Transmission

The article describes in detail the regulatory procedures to be performed for an application for designation as a conformity assessment body under the new...

MDCG Guidance on Conformity Assessment Bodies and Notified Bodies: Application Pre-assessment

The article provides an overview of the European regulatory requirements in the sphere of conformity assessment bodies and notified bodies set forth by the...

MDCG Guidance on Alternative Solutions for IVDs: Overview

The article provides an overview of the clarifications provided concerning solutions available during the temporary unavailability of the global European database.  ...

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