The Medical Device Coordination Group (MDCG) recently released guidance MDCG 2024-10, focusing on the clinical evaluation of orphan medical devices.... read more
The Investigator´s Brochure (IB) is a critical document in the realm of clinical research for medical devices. As mandated by... read more
Introduction In the highly regulated and competitive world of medical device development, the choice of a Clinical Research Organization (CRO)... read more
The Medical Device Regulation (MDR) 2017/745 has transformed the EU’s regulatory landscape for medical devices. It aims to boost patient... read more
Selecting an ISO 14155-compliant MedTech CRO under EU MDR ensures enhanced data reliability and patient safety. This compliance is key... read more
The EU Medical Device Regulation (MDR) has established a rigorous regulatory framework for the entry of investigational devices into the... read more
In the intricate world of medical device regulation, the European Union Medical Device Regulation (EU MDR) stands out as a... read more
The world of medical device regulation is constantly evolving, with regulatory bodies introducing new guidances to keep up with the... read more
The Medical Device Coordination Group (MDCG) plays a key role in setting the rules for medical devices in the European... read more
The recent amendment of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) through Regulation (EU)... read more
In this article, we will delve into the intricacies of developing a robust Clinical Evaluation Plan using expert regulatory terminology,... read more
How are medical devices without an intended medical purpose regulated under the MDR Annex XVI? Continue reading to learn more.
Following the end of a clinical investigation and irrespective of its outcome, the Regulation (EU) 2017/745 (MDR) and the International... read more
The field of medical devices is continually evolving, with new technologies and innovative products constantly being developed to improve patient... read more
In our latest article, MDx offers a comprehensive summary of the European Commission’s Q&A document, focusing on the implementation of... read more
The EU Medical Device Regulation has introduced significant changes to the requirements for clinical evaluation reports of medical devices. This... read more
Since the implementation of the new EU MDR, there has been significant standardization in the processing of clinical investigation submissions... read more
In light of the forthcoming Medical Device Regulation (MDR) and the delay in the complete functionality of the electronic system... read more
Assisting with the EU Medical Devices Regulation Europe faces imminent shortages of medical equipment needed by hospitals and clinicians to... read more
This scientific opinion represents independent specialists’ opinions (MDR Article 106) on the notified body’s Clinical Evaluation Assessment Report (CEAR). Clinical... read more
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