La AEMPSgob publica el texto del proyecto de Real Decreto por el que se regulan los productos sanitarios

by Tecno-med Ingenieros

3 years ago
AEMPS, medicaldevices, MDR, productos sanitario

La AEMPS publica el esperado texto del proyecto de Real Decreto de productos sanitarios, este derogará los reales decretos1591/2009 y1616/2009

Does the MDR mean the end of the equivalence route for clinical evaluations?

by AKRN Scientific Consulting

3 years ago
clinical safety, clinical investigations, MDR

In Europe, medical device manufacturers with products on the market have long used clinical data from equivalent devices to confirm the clinical safety and performance of their devices. Using clinical...

Updates on the Ongoing guidance development within MDCG Subgroups

by Asphalion

4 years ago
MDCG, guidance, artificial intelligence, antibody tests, medical devices, MDR

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...

Publicado Reglamento de ejecución (UE) 2020/1207 especificaciones comunes reprocesamiento ps un solo uso

by Tecno-med Ingenieros

4 years ago
productos de un solo uso, MDR, reprocesamiento, legislación

El MDR sólo permite el reprocesamiento de productos de un solo uso únicamente cuando lo permita la legislación nacional, por lo que habrá que ver lo que establece el Real Decreto español y si per...

MDR | Guidance documents and updates on clinical investigation and evaluation

by Asphalion

4 years ago
medical devices, MDR, guidance

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...

La Comisión Europea analiza de la capacidad de los ON para la evaluación de productos sanitarios COVID-19

by Tecno-med Ingenieros

4 years ago
tiempos, productos sanitarios, MDR, covid-19

En este informe se revisan los tiempos para que un Organismo Notificado pueda dar el certificado según MDD o MDR para un producto sanitario de los precisos para la COVID.

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

by Tecno-med Ingenieros

4 years ago
medical devices, MDR, reglamentos, IVDR

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...

Commission Implementing Decision C(2020) 2532

by Asphalion

4 years ago
European Commission, standards, MDR, IVDR

The European Commission (EC) has published a Commission Implementing Decision requesting a review (standardisation) of a set of existing standards, as well as new standards to be drafted, for support ...

WEBINAR | MDR postponed: an opportunity that cannot be missed

by Asphalion

4 years ago
medical devices, MDR, opportunity

Our last webinar is available on Asphalion’s YouTube Channel.

FORMACIÓN MDR : 2003C - 'WEBINAR MDR FALTA 1 AÑO' de 10:00 h a 11:30 h

by Tecno-med Ingenieros

4 years ago
formación, webinar

Les informamos de la apertura de inscripciones para nuestra próxima Formación WEBINAR EN DIRECTO DE 1'5 horas en directo + 8 horas en teleformación del día 26 de mayo de 2020:

COVID-19 impact on MDR | European Commission working to postpone MDR for 1-year

by Asphalion

4 years ago
healthcare professionals, covid-19, MDR, European Commission

Due to the outbreak of the pandemic of COVID-19, the Medical Devices (MD) manufacturers all along European Union (EU) have had to increase their efforts to supply all the Member States with the vit...