The field of personalized medicine is experiencing notable progress as BSI and TÜV SÜD, two of the largest Notified Bodies in the European Union, have issued their first Companion Diagnostic (CDx) Certificates under the In Vitro Diagnostics Regulation (IVDR). This... read more
How are medical devices without an intended medical purpose regulated under the MDR Annex XVI? Continue reading to learn more. The Medical Devices Regulation (MDR) 2017/745 has significantly changed the European Union’s (EU) regulatory landscape for medical devices. While prioritizing... read more
Are you ready for the new regulation on In Vitro Diagnostic medical devices in Spain? Learn everything you need to know about it. The in vitro diagnostic medical device sector plays an important role in healthcare by providing instruments and... read more
Following the end of a clinical investigation and irrespective of its outcome, the Regulation (EU) 2017/745 (MDR) and the International Organization for Standardization (ISO) 14155:2020, the Sponsor shall prepare a Clinical Investigation Report (CIR) or sometimes also called the Clinical... read more
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
What are the most important things you’ll need to know when it comes to IVDR pre-submission assessment? Continue reading. The In Vitro Diagnostic Regulation (IVDR) is a new regulation that took effect on May 26, 2022, replacing the In Vitro... read more
What are some of the most important things you’ll need to know for IVD clinical trials in 2023? Continue reading to learn more. In-vitro diagnostics (IVD) are tests performed on biological samples, such as blood or tissue, to diagnose or... read more
The field of medical devices is continually evolving, with new technologies and innovative products constantly being developed to improve patient care and enhance the practice of medicine.In Spain, the regulatory landscape governing clinical investigations of medical devices has recently undergone... read more
The healthcare industry is undergoing a rapid transformation spurred by the advent of advanced medical diagnostic technology. IVD software development is a critical component of this revolution as it allows for testing, analysis, reporting, and communication without needing a physical... read more
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
The Medical Device Regulation (EU MDR) has introduced significant changes to the requirements for clinical evaluation of medical devices. This article will provide a comprehensive guide on incorporating the most relevant guidance from MDCG 2020-6, MDCG 2020-5, MDCG 2020-13, MEDDEV... read more
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
One of the critical steps in IVD development is the conduct of an IVDR clinical performance study to generate reliable and meaningful data to support regulatory approval and the device’s commercial success. In Europe, the in-vitro diagnostic regulation (EU IVDR)... read more
MDx summarize the key updates to the MedTech Europe Regulatory eBook Clinical Evidence Requirements under the EU In Vitro Diagnostics Regulation (IVDR) Version 3, published in February 2023, emphasizing the relevance of the CDx, clinical performance studies, similar/equivalent concepts, and... read more
Since the implementation of the new EU MDR, there has been significant standardization in the processing of clinical investigation submissions throughout Europe. Each country, however, may have its own national provisions. This article is intended for clinical research experts who need... read more
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
In recent years, there has been a dramatic increase in the use of digital health tools health in order to improve service quality, system effectiveness, and facility administration. The COVID-19 epidemic hastened this pattern. eHealth, often known as digital health,... read more
Because the electronic system referenced to in Article 73 (Eudamed) will not be ready and completely functioning on the MDR’s effective date, this guideline covers the processes for safety reporting in clinical research in the absence of Eudamed. MDCG 2020-10... read more
Assisting with the EU Medical Devices Regulation Europe faces imminent shortages of medical equipment needed by hospitals and clinicians to treat patients. This dangerous disease affects both new and old devices. The EU institutions must take urgent and decisive action.... read more
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
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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