BREXIT | What’s new for Pharma and Medical Devices

by Asphalion

Providing guidance about Regulatory Affairs and Trade changes in the Pharma and Medical Devices industries

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WHITE PAPER | The EU Regulatory Environment of Medical Devices Software Development

by Asphalion

​New Medical Devices Software (MDSW) should be developed in Europe in accordance with the requirements of the new legislative framework given by REGULATION (EU) 2017/745 on medical devices (hereinaf...

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Dominique Monferrer – New Medical Devices Director

by Asphalion

Asphalion’s Board of Directors is pleased to announce the appointment of Dominique Monferrer as new Medical Devices Director.

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Asphalion celebrates 15,000 followers on LinkedIn!

by Asphalion

Today is an exciting day for Asphalion as we have reached 15,000 followers on LinkedIn!

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Updates on the Ongoing guidance development within MDCG Subgroups

by Asphalion

Now that the year is about to come to an end, the European Commission has updated the information on the MDCG’s work in progress, indicating the planning for the endorsement of the guidance document...

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Nueva sección de la web de la Comision para la puesta en marcha 1/12/2020 del modulo de registro de actores de EUDAMED

by Tecno-med Ingenieros

EUDAMED es 22 de mayo de 2022 la Comisión Europea ha confirmado su interés en hacer disponibles los 6 módulos gradualmente, y ha anunciado la apertura del modulo de registro de actores incluyendo e...

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Brexit | New guidance documents from MHRA

by Asphalion

From 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s standalone medicines and medical devices regulator.

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MDR | Guidance documents and updates on clinical investigation and evaluation

by Asphalion

Although the date of application of the Medical Devices Regulation (MDR) has been postponed, on 26 May 2021 the Regulation will become fully applicable, following the transition period. As​ previous...

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Craash Barcelona | Regulatory Aspects for Medical Devices by Dominique Monferrer

by Asphalion

Dominique Monferrer, Asphalion’s Medical Devices Expert, was invited to give a talk on Regulatory Aspects for Medical Devices to participants of the 3rd edition of Craash Barcelona program organized...

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Asphalion attended the online session 'Improving Human Health Through Artificial Intelligence'

by Asphalion

Rainer Rothe, Scientific and Regulatory Affairs Officer at Asphalion, attended the online session “Improving Human Health Through Artificial Intelligence” organised by CataloniaBio & HealthTech in...

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Rechazado el nuevo mandato de normalización para las normas armonizadas con MDR e IVDR

by Tecno-med Ingenieros

Después de varios desencuentros… e.g. publicación de EN ISO 14971:2019 y EN ISO 24971:2020 sin anexos Z, el comité CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical d...

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New regulation to ease the renewal of the designation of NBs and prevent shortages of MDs in the EU

by Asphalion

The European Commission (EC) has published a Commission Implementing Regulation to ease the renewal of the designation of notified bodies (NBs) and prevent shortages of medical devices (MDs) in the Eu...

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