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What is the Regulatory Process for IVD in Europe?

What is the Regulatory Process for IVD in Europe?

IVD news May 10, 2023

What is the regulatory process for IVD in Europe, and which are the most important aspects of it? Continue reading to learn more. The In Vitro Diagnostic (IVD) market in Europe is regulated by a complex framework, and understanding the... read more

EU Q&A Guide: Amendments to MDR and IVDR Transitional Provisions

EU Q&A Guide: Amendments to MDR and IVDR Transitional Provisions

MEDTECH news March 27, 2023

In our latest article, MDx offers a comprehensive summary of the European Commission’s Q&A document, focusing on the implementation of Regulation (EU) 2023/607, which amends transitional provisions for specific medical devices and in vitro diagnostic devices under Regulations (EU) 2017/745... read more

IVDR technical documentation guidance released by Team-NB

IVDR technical documentation guidance released by Team-NB

IVD news March 13, 2023

If you’re still undecided on which Notified Body (NB) to choose or you’re in the early stages of development, Team-NB has just released this best practice guidance Guidance for the Submission of Technical Documentation under Annex II and III of... read more

The Impact of the IVDR and MDCG 2023-1 on LDT

The Impact of the IVDR and MDCG 2023-1 on LDT

IVD news January 12, 2023

On May 26, 2022 the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) has become fully applicable with major consequences not only for manufacturers of IVDs but also for all diagnostic laboratories, particularly those that manufacture in-house... read more

The future of in vitro diagnostics

The future of in vitro diagnostics

IVD news November 2, 2022

Although there has been a significant growth in recent years in the understanding of the crucial role that diagnostics play in European healthcare, diagnostics firms still confront numerous difficulties in the design, development, funding, regulation, and adoption of new products.... read more


Fondo Social Europeo dentro de la Ayuda a la Recuperación para la Cohesión y los Territorios de Europa (REACT-UE)

MED IVD HEALTHTECH S.L ha sido beneficiaria de la subvención de contratos de trabajo de la Comunidad de Madrid, cofinanciado por el Fondo Social Europeo dentro de la Ayuda a la Recuperación para la Cohesión y los Territorios de Europa (REACT-UE), a través del Programa Operativo Regional FSE, en el marco del Programa Impulso a la Contratación Estable de Jóvenes para la Recuperación Económica, gestionado por la Dirección General del Servicio Público de empleo de la Consejería de Economía, hacienda y empleo de la Comunidad de Madrid.


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