MedTech Market Access Insight
MDR Regulator
Medical Devices ?? In vitro diagnostic medical devices ?? Personal protective equipment (PPE) ?? Certification process
April 2024
Changes in the Investigator’s Brochure content - MDCG 2024-5
The revised guidance emphasizes the importance of the Investigator’s Brochure (IB) as part of the required documentation, providing technical and clinical data about the device being investigated. Sponsors are encouraged to use a checklist provided in the guidance document to ensure completeness and compliance with Article 70 of the MDR. It also clarifies that the guidance applies specifically to IBs for clinical investigations under the MDR and not to performance study IBs under the IVDR.
European Commission’s Dashboard about reprocessing of medical devices
The concept of "reprocessing" in the context of medical devices refers to the process of safely preparing a used device for reuse through cleaning, disinfection, sterilization, and related procedures. The European Commission's Directorate-General for Health and Food Safety commissioned a study to evaluate the implementation of Article 17 of the MDR on the EU market. As part of the study, a dashboard has been developed to provide an overview of mapping activities related to the reprocessing and reuse of single-use devices in the EU.
Information from Swiss Medtech on placing on the market
During the shift from MDD to MDR, MDD-compliant devices can only be introduced into the Swiss market until a specified date. Consequently, there's a potential scenario where certain products currently stocked in Swiss warehouses may become unsellable on May 27, 2024. To mitigate this risk, Swiss Medtech has developed a guidance document.
European Health Data Space (EHDS)
The European Parliament's adoption of the European Health Data Space (EHDS), gives a significant step towards establishing a resilient European Health Union. The EHDS aims to empower citizens by granting them control over their healthcare data and facilitating its use for research and public health initiatives under strict conditions. Implementation of the EHDS will provide EU citizens with access to their digital health data across borders, improving evidence-based decision-making and crisis readiness while adhering to stringent data security and access standards.
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Polymers in medicine, 21.05.2024 ?ód?
The aim of the conference is to provide knowledge and exchange scientific experience on the wide application of natural and synthetic polymers in medicine, pharmacy and dentistry.
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RAPS Euro Convergence, 06-08.05.2024 Berlin
RAPS Euro Convergence is the most comprehensive regulatory affairs conference in Europe, focusing on the latest developments in healthcare products in Europe and beyond—medical devices, IVDs, pharmaceuticals, and AI and Software.
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