Tag: EU MDR IVDR

MDCG Manual on Borderline Products: Key Principles in Detail

Medical Devices October 4, 2022

The article highlights the key points to be considered when determining the regulatory nature of products considered general medical devices. Table...

EU Manual on Borderline and Classification for Medical Devices: Overview

Medical Devices September 23, 2022

MDCG Position Paper on Notified Bodies

Medical Devices September 15, 2022

MDCG Guidance on CABs and NBs: Re-assessment

Medical Devices September 11, 2022

MDCG Guidance on CABs and NBs: Notification and Publication

Medical DevicesSeptember 6, 2022

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

Medical DevicesSeptember 3, 2022

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

Medical DevicesSeptember 3, 2022

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

Medical DevicesAugust 24, 2022

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

Medical DevicesAugust 19, 2022

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

Medical DevicesAugust 15, 2022

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

Medical DevicesJuly 19, 2022

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