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State of the art

Do you know if your medical device meets the regulatory requirement of “state of the art”? Can you answer your notified body’s question about the “state of the art” during the initial or ......

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Clinical Evaluation-introduction

The new MDR emphasizes sufficient clinical evidence based on clinical data for demonstrating conformity of medical device and complements the clinical requirements of the MDD/ AIMDD ......

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Pending MRA of CH-EU

As of 26 May 2021, the EU MDR has entered into force, but a necessary MRA between Switzerland and European Union is still pending. Without a valid MRA mutual access to …..

EMDN

Understand and correctly identify the EMDN (European Medical Device Nomenclature) for your medical device as the device’s UDI-DI information is connected with codes .....

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UDI-China

From 1st January 2021 after a pilot phase, the UDI requirements first becomes mandatory for the high-risk, i.e. Class III medical devices in China. Along with the full publication of the first …..

Understand “Standard”

Understand the terms of harmonised European standard, standard and technical specification, which are important for the implementation of the EU Medical Device Regulation.

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ECG Monitoring

Get an overview about global ECG monitoring market, the types of ECG monitors and regulatory requirements for the market.

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UDI Issuing Bodies

Selecting a suitable UDI issuing body meets your requirements.

NMPA Regulation Revision

China’s National Medical Products Administration (NMPA) published the revised regulation on the Supervision and Administration of Medical Devices on 19 March 2021

EUDAMED

“actor registration module” is live now.

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