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Stability studies are critical to ensuring the safety and efficacy of medical devices and in vitro diagnostics. This article offers valuable insights into conducting and interpreting these studies. Read more: Stability Studies on Medical Devices and In Vitro Diagnostics #MedicalDevices #IVD #StabilityStudies #HealthcareQuality #RegulatoryCompliance https://lnkd.in/duwKTzvW

Medical Information🫀 👇🏽 Medical Equipment Classifications For example: IVD machines In vitro diagnostic (IVD) medical devices are classified into four risk classes ranging from low to high risk: Class A, B, C, and D. As with medical devices, the risk class for IVD medical devices is determined by the manufacturer's intended purpose and the potential risks associated with the device's use. For IVD medical devices, the risk of using the device encompasses both the risk to individual patients and the risk to public health. Class A: Low individual risk and low risk to public health. For Class A devices that are placed on the market in a sterile state, a notified body must be involved in the conformity assessment of the components related to sterilization. Class B: Moderate individual risk and/or low risk to public health. Requires conformity assessment by a notified body. Class C: High individual risk and/or moderate risk to public health. Requires conformity assessment by a notified body. Class D: High individual risk and high risk to public health. Requires conformity assessment by a notified body.

*This article is an excerpt of some of the original text. Key tasks for the advancement of the medical device industry.  - Role of KMDIA for Leading Medical Device Industry written by Kim Young-min(Chairman of KMDIA) Expansion of Export Support and Policy Formulation for the Medical Device Market Firstly, we aim to push ahead with plans to enter the world's top 7 medical device market and ahcieve the government's goal about export. Specifically, we seek to explore support measures for fostering manufacturing and support key items such as innovative medical devices, cosmetic treatments, and in vitro diagnostics.  Additionally, we will strengthen cooperation with relevant domestic ministries. By expanding the scope of the association's activities. We aim to propose policies that integrate various ministries' policies and formulate policies that benefit the entire industry. Efforts to Communicate with the Medical Device Industry Secondly, we will pursue strengthening communication with the government to resolve existing industry issues. We aim to improve the evaluation of new medical technologies and facilitate rapid market access and accessibility through the pre-entry and post-evaluation system for all medical devices. It is a reality that the market accessibility of products approved and certified by the Ministry of Food and Drug Safety (MFDS) has been blocked due to the new medical technology evaluation system. Situations where products that have certified by MFDS as new product approvals are prohibited from sale due to failure to pass new medical technology evaluations need to be improved. Creating a Leading Association for the Medical Device Industry Thirdly, we will create a association that leads the medical device industry towards development. To achieve this, we plan to promote ESG-centered businesses to strengthen the internal and external status of the association. Financial evaluation is important, but ESG (environmental, social, governance) initiatives are essential for enhancing non-financial evaluations. Additionally, we aim to make a "medical device industry with one voice" We will promote joint discussions involving organizations encompassing the medical device industry. We plan to establish a joint discussion body involving various medical device organizations to formulate joint industry policies based on regular meetings of the heads of four medical device organizations, Lastly, we will strive to make a "leading association." We will establish and operate a management support center for member companies. - Original text link : https://lnkd.in/gTUGVCgm

🚀 MDCG Guidance update! 🚀 Are you developing an in-vitro diagnostic (IVD) product? Here is an interesting read! The MDCG has released Revision 3 of MDCG 2020-16, titled 'Guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746' We've added the guidance to this post. #MedicalDevices #EU #RegulatoryCompliance #MDCG #ivdr

✔️4C Medical Technologies, Inc. announced the FDA granted breakthrough device designation for its AltaValve system. The company received designations for two therapeutic indications for the transcatheter mitral valve replacement device. 👏Saravana Kumar, CEO and President commented: “This advancement enables us the opportunity to bring this needed technology to our patients even sooner.” 🔗Read more: https://lnkd.in/dJjiTFhJ 📰 Follow Guided Solutions to receive the latest #MedTech news daily and subscribe to our weekly newsletter: https://lnkd.in/dYC56Usw #MedicalDevices #MedicalDevice #MedicalEquipment #Medicine #Surgeons #GuidedSolutions

Medical Device Registration Process In Europe 🌐 🤔 Wondering about the process and requirements for registering your medical device in Europe? Click the link below to navigate the registration process for your medical & IVD devices. #MedicalDevices #EURegulations #DeviceRegistration 👉 Contact @Credevo for registration support in Europe https://buff.ly/3U7UoG5

Learn why Biocompatibility Studies are essential for patient safety, regulatory compliance, and innovative product development in the medical device industry. In this blog discover the importance, processes, and regulatory landscape of biocompatibility studies and how they ensure materials used in medical devices interact safely with the human body- https://lnkd.in/gnktj6sC At GV Research Platform (GVRP), we provide comprehensive biocompatibility testing services to meet stringent regulatory standards. Check out our blog and see how we can support your journey towards safer and more effective medical devices. You can also leave your enquiry here and our team will get in touch with you - https://gvrp.in/enquiry/ Read more and fill out our enquiry form here: https://lnkd.in/gnktj6sC #MedicalDevices #Biocompatibility #PatientSafety #RegulatoryCompliance #MedicalResearch #Innovation #GVRP

Medical Devices proposal for amending (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices https://lnkd.in/dBiR3fsU The European Commission has proposed an amendment to the Medical Devices Regulation (MDR) and to the In Vitro Diagnostic Medical Devices Regulation (IVDR) in order to not only enhance safety and transparency but also giving more time to medical devices manufacturers to adapt to such regulations. The new proposal introduces three key changes: Extension of the transition periods The proposal introduces extended deadlines for manufacturers and NB to comply with the IVDR by giving them more time to complete, under certain conditions, the necessary conformity assessment procedures without lowering the requirements. High-risk devices (that is, class D devices according to the IVDR) have until December 2027, devices with high individual and moderate public health risk (IVDR class C devices) until December 2028, and lower-risk devices (class B and A sterile devices) until December 2029. This should mitigate the shortage of IVDR at least in a short-term period. Accelerated EUDAMED implementation The European Database on Medical Devices (EUDAMED) will contain information about all medical devices and IVDRs placed on the EU market and consists of six modules: agency registration; Unique Device Identification and product registration; bodies and certificates; clinical investigations and performance studies; post-market surveillance and vigilance; and market surveillance. The first three modules are currently available on a voluntary basis, while the post-marketing surveillance and vigilance and market surveillance modules are expected to be completed in 2024. The clinical investigations and performance studies module is not expected to be completed until the third quarter of 2026. The Commission has proposed a phased roll-out of EUDAMED to facilitate effective implementation of the MDR and IVDR and intends to make its use mandatory once the modules have been audited and declared functional. The Commission sustains that such measure is crucial for ensuring the availability of in vitro diagnostics, enhancing transparency in the MD sector and supporting patient care without imposing unnecessary burdens on manufacturers. Mandatory prior notice for supply interruptions At least 6 m in advance, manufacturers are required to notify competent authorities, distributors and healthcare providers, if they anticipate a disruption or discontinuation in the supply of IVDR or MD. https://lnkd.in/dmwKnUGt

Publication of the third revision of the MDCG 2020-16 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - July 2024. The following changes have been implemented: - Addition of ‘kit’ definition - Rule 3(a): Revision of examples - Rule 4(a) / Rule 5(c): Revised - Rule 6: Minor revision of example Link: https://lnkd.in/eJu-7v8C #MDCG #DMDIV #Classification

The European Commission proposed a new extension for compliance with the In Vitro Diagnostic Medical Devices Regulation (#IVDR) with the aim of preventing potential supply disruptions. In this blog post, we present some key actions to consider while working toward regulatory compliance.