Nicht kategorisiert Archive - Page 2 of 2

Additional Requirements for Importers and Distributor by Authorities

by nrdigital | Oct 25, 2023 | Nicht kategorisiert

It is no longer new that Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) impose certain requirements on importers and distributors of medical devices. These requirements are described in detail in: Article 13: General obligations of importers...

Important Change Regarding Reporting Incidents in the United Kingdom (UK)

by nrdigital | Aug 22, 2023 | Nicht kategorisiert

Starting from August 31, 2023, reports of adverse events related to medical devices that have occurred in the United Kingdom (UK) can only be submitted through the national MORE-Portal (Manufacturer Online Reporting) of the Medicines & Healthcare products...

Actor registration module

by nrdigital | Oct 23, 2020 | Nicht kategorisiert

As of December 01, 2020 the European Commission will make the Actor registration module available which will be the first of six EUDAMED modules. Read more on Youregulate…

New and current standards have been harmonized with the current directives!

by nrdigital | May 26, 2020 | Nicht kategorisiert

On 25 March 2020, the Commission adopted three Implementing Decisions on harmonised standards which will allow manufacturers to place on the market devices that play a pivotal role in the current coronavirus pandemic for MDD 93:42:EEC.pdf: 264 harmonised standards...

Additional Requirements for Importers and Distributor by Authorities

Important Change Regarding Reporting Incidents in the United Kingdom (UK)

Actor registration module

New and current standards have been harmonized with the current directives!

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