TÜV SÜD’s Post

𝗪𝗲 𝗺𝗮𝗱𝗲 𝘁𝗵𝗲 𝘀𝗵𝗶𝗳𝘁 𝘁𝗼 𝗠𝗗𝗥 We've successfully made the shift from the Medical Device Directive (MDD) to the more rigorous Medical Device Regulation (MDR) certification for our DOTCH® Puru Syringes. This achievement underscores our commitment to deliver safe, high-quality medical devices. Obtaining a Medical Device Regulation (MDR) certificate has become quite a challenge for manufacturers in the medical industry.  With the implementation of the MDR the regulatory landscape has significantly evolved, bringing with it heightened scrutiny and requirements. The industry-wide shift is challenging, requiring substantial resources and time. Yet, it is a necessary step to keep up with advancements in healthcare and ensure that medical devices meet the highest safety and quality standards. The differences between the MDR and its predecessor, the MDD, are substantial. The MDR introduces more stringent regulations and standards, emphasizing the safety and efficacy of medical devices to a greater extent. It places a stronger emphasis on post-market surveillance and transparency throughout the supply chain. One of the most significant challenges faced by manufacturers in obtaining MDR certification is due to the limited number of notified bodies accredited to issue MDR certificates. This has led to longer review times, while the increased scrutiny of documentation and quality management systems under the MDR adds additional complexity. Obtaining the MDR certification not only reflects our dedication to safety and quality but also highlights our capacity for growth and our ability to navigate complex regulatory landscapes. Together with STAXS®, you benefit from products and services backed by scientific credibility and rigorous standards. #STAXS #DOTCH #Syringes #MDR #MedicalDeviceRegulation

🔔 Regulatory News for Medical Devices: Regulation (EU) 2024/1860 The European Union has adopted Regulation (EU) 2024/1860, amending Regulations (EU) 2017/745 and (EU) 2017/746. This update streamlines the roll-out of the European database on medical devices (Eudamed) and ensures the continuous supply of essential in vitro diagnostic medical devices (IVDs). Key points include: 📊 Gradual Roll-out of Eudamed: The regulation permits the phased implementation of Eudamed's electronic systems, enhancing transparency and traceability within the medical devices market. Four of the seven interconnected electronic systems are complete, with the remaining systems expected by 2024. ⏳ Extended Transitional Periods for IVDs: To prevent shortages, the transitional periods for IVDs have been extended, ensuring the availability of critical medical devices during the transition to the new regulatory framework. Class D Devices: Extended until 31 December 2027 Class C Devices: Extended until 31 December 2028 Class B Devices: Extended until 31 December 2029 Class A Sterile Devices: Extended until 31 December 2029 📢 New Obligations for Manufacturers: Manufacturers must notify competent authorities and economic operators at least six months in advance if they anticipate an interruption or discontinuation of device supply. This requirement aims to mitigate risks of serious harm to patients or public health due to potential device shortages. 🔍 Enhanced Surveillance and Certification: Surveillance responsibilities for IVDs benefiting from the extended transitional period will be transferred to notified bodies designated under the new regulations. This ensures ongoing compliance with high safety and quality standards. 💡 Impact on Market and Patient Safety: The regulation emphasizes a balanced approach between ensuring sufficient notified body capacity and maintaining high levels of patient safety and public health protection. Follow us for more updates! Biomedista #MedicalDevices #EURegulations #Eudamed #Healthcare #PatientSafety #IVD #RegulatoryAffairs

🇪🇺 For Manufacturers and Notified Bodies of Medical Devices in Europe The Medical Device Coordination Group (MDCG) has recently released Revision 2 of their guidance document on appropriate surveillance for legacy medical devices under the MDR’s (Medical Devices Regulation) transitional provisions (Article 120). This revision reflects recent regulatory changes from Regulation (EU) 2023/607. The MDR allows certain legacy devices, under specific conditions, to remain on the market until established deadlines (depending on classification). A crucial requirement for this extended market access is continued appropriate surveillance by a notified body. 🔍 Key Points from the Updated Guidance: Manufacturers: The document clarifies ongoing obligations regarding quality management systems. Manufacturers must demonstrate processes to maintain compliance with relevant regulations throughout the legacy device’s lifecycle. Notified Bodies: The guidance details elements to assess during surveillance, ensuring a thorough evaluation of the legacy device’s continued safety and performance. This revision aligns with the position outlined in the previous MDCG document, MDCG 2022-14. 🤔 Questions? If you have any inquiries about the new amendments, transition, or conformity of your medical devices (MD) and in vitro diagnostic medical devices (IVDs), don’t hesitate to contact us: info@tsquality.it 🔗 #TransitionalProvisions #LegacyDevices #NotifiedBody #QualityManagementSystem #PatientSafety #RegulatoryAffairs #EURegulations #regulatorycompliance #readiness #medtechindustry #NB #healthcare #publichealth

The patient safety and outcomes will be likely impacted adversely with the grant of timeline extension to manufacturers and importers of high risk medical devices and consumables. #patientsafety #publichealth #medicaldevices #quality #regulatorycompliance #postmarketsurveillance #adverseevents #healthpolicy

For manufacturers of #medicaldevices without an intended medical purpose in the EU. 🇪🇺 This week the Medical Device Coordination Group issued two new guidances for manufacturers and #notifiedbodies of Annex XVI products (products without an intended medical purpose). This guidance #MDCG 2023-5 addresses the qualification and classification process of products without an intended medical purpose listed in Annex XVI to the #MDR (Medical Device Regulation). It provides valuable insights, explanations, and examples for applying classification rules to such devices. Classification rules come into play after establishing the qualification of the product as a device. Commission Implementing Regulation (EU) 2022/2347 also applies to the classification of certain active devices without an intended medical purpose. The MDR encompasses products without an intended medical purpose listed in Annex XVI. Qualification of such products precedes classification, and only those qualifying as devices and covered by CS and MDR are subject to further classification rules (Annex VIII to MDR and Commission Implementing Regulation (EU) 2022/2347 on reclassification). 💡Use this guidance document in conjunction with MDCG 2021-24 on classification of medical devices and consider Commission Implementing Regulation (EU) 2022/2347 on reclassification. Do you have any questions around the conformity of your medical devices #MD and in vitro diagnostic medical devices #IVDs? Don’t hesitate to contact us. We are here to help. ☞ meetus@taoexcellence.ch #regulatoryaffairs #regulatorycompliance #medtech #medtechindustry #qualitiymanagement #riskmanagement #QMS #RM #invitrodiagnostics #regulatoryupdates #IVDR #regulations #healthcare #medicaldevicesafety #compliance 

         🔬 Exciting Developments in Medical Device Regulation! 🌡️ In the ever-evolving landscape of medical devices, Post-Market Clinical Follow-up (PMCF) plays a pivotal role in ensuring the safety and efficacy of our products. 🏥 📌 PMCF is not new in MDR, and With guidance from the MDCG, preparing a PMCF plan might seem accessible, but implementing an appropriate PMCF activity is no small feat. 🌟 PMCF is a proactive part of Post-Market Surveillance (PMS), emphasizing the importance of proactive data collection, while Vigilance remains reactive in addressing issues. 💡 Robust clinical data is the backbone of a rigorous PMCF report, reflecting the quality and reliability of your medical devices. 🔍 Search or investigation? Manufacturers should access clinical data from equivalent devices and initiate their clinical investigations to confirm this data's relevance. 🌐 Approvals for PMCF reports by Ethical Groups can vary by territory within the EU, reflecting the regional nuances of medical device regulation. 📊 Sample size considerations in PMCF are closely tied to medical device classification. Understanding this interaction is critical for effective PMCF planning. 📈 For legacy devices with substantial market presence, the need for PMCF must be carefully assessed, with a clear understanding of the interplay between PMCF, PMS, and QMS. At Med-Di-Dia Ltd., we are committed to navigating the complexities of PMCF and ensuring your medical devices meet the highest regulatory standards. Reach out to us for expert guidance in this dynamic field! 💼👩⚕️👨⚕️ #MedTech #MDR #PMCF #RegulatoryCompliance #MedDiDiaLtd #MedicalDevices #PostMarketSurveillance

For manufacturers and #NotifiedBodies of #MedicalDevices in #Europe. 🇪🇺 The Medical Device Coordination Group #MDCG has released Revision 2 of their guidance document on appropriate surveillance for legacy medical devices under the #MDR’s (Medical Devices Regulation) transitional provisions (Article 120). This revision reflects recent regulatory changes from Regulation (EU) 2023/607. The MDR allows certain legacy devices, under specific conditions, to remain on the market until established deadlines (depending on classification). A crucial requirement for this extended market access is continued appropriate surveillance by a notified body. This updated guidance provides clarity on the activities involved in this surveillance, outlining expectations for both: 🔹 Manufacturers: The document clarifies their ongoing obligations regarding their quality management systems. Manufacturers must demonstrate they have processes in place to maintain compliance with the relevant regulations throughout the legacy device's lifecycle. 🔹 Notified Bodies: The guidance details the elements they should assess during surveillance, ensuring a thorough evaluation of the legacy device's continued safety and performance. This revision aligns with the position outlined by the MDCG in their previous document, MDCG 2022-14. Do you have any questions around the new amendments and its details, the transition or the conformity of your medical devices #MD and in vitro diagnostic medical devices #IVDs? Don’t hesitate to contact us. We are here to help. ☞ meetus@taoexcellence.ch #TransitionalProvisions #LegacyDevices #NotifiedBody #QualityManagementSystem #PatientSafety #RegulatoryAffairs #EURegulations #regulatorycompliance #readiness #medtechindustry #NB #healthcare #publichealth 

We all should focus on ensuring the quality, safety, and performance of medical devices. To build a trust-based, robust system, we must implement strict protocols and rigorous check-back mechanisms. Reporting #adverseevents is crucial, especially for incidents that could lead to death or serious injury requiring surgical intervention. However, this process should not devolve into a witch hunt by #Regulators. Instead, it should facilitate a systematic review to ensure patient safety. This approach will encourage manufacturers to self-report and work collaboratively towards safer devices. Let's focus on building trust. It's important to recognize that not all serious adverse events stem from manufacturing defects. Sometimes, incorrect or abnormal usage, or even abuse of the medical device, can be the cause. In such cases, the manufacturer should not be held solely responsible. Instead, there should be an emphasis on improving instructions for use (IFU) and enhancing product familiarization training. Let's work together to create a safer environment for all. #MedicalDevices #PatientSafety #RegulatoryAffairs https://lnkd.in/g3tZWmdv

【ᴍʜʀᴀ　ᴀɴɴᴏᴜɴᴄᴇꜱ　ᴛᴡᴏ　ɴᴇᴡ　ᴜᴋ　ᴀᴘᴘʀᴏᴠᴇᴅ　ʙᴏᴅɪᴇꜱ　ᴛᴏ　ᴄᴇʀᴛɪꜰʏ　ᴍᴇᴅɪᴄᴀʟ　ᴅᴇᴠɪᴄᴇꜱ】 The Medicines and Healthcare products Regulatory Agency (MHRA) has designated two new UK Approved Bodies, delivering increased capacity for the certification of the performance and safety of medical devices, for healthcare professionals and the public. increasing capacity for the certification of medical devices in the UK. LNE-GMED UK has been designated as a UK Approved Body to assess and certify general medical devices in accordance with Part II of the UK Medical Devices Regulations 2002. Scarlet NB UK has been designated with a focus on assessing and certifying software and AI as a medical device (AI/SaMD). This comes after two of the existing UK Approved Bodies had their scope expanded, with UL International UK now designated to assess and certify general medical devices (in addition to in-vitro devices), and TÜV SÜD now designated to assess and certify active implantables (in addition to general medical devices). Apart from the very lowest risk devices, manufacturers must apply to a UK approved body for UKCA certification. Products can only be placed on the market in England, Wales and Scotland after they have achieved certification. Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said: Our mission is to ensure that patients have access to the high-quality, safe and effective products they need to protect their health. Approved Bodies play a critical role in the supply of medical devices and expanding capacity in this area is a key priority for us, to support manufacturers to bring their products to the UK. Before appointing an Approved Body, the MHRA conducts a detailed assessment process to ensure that organisations: are stable and able to undertake impartial and objective conformity assessment activities have an appropriate quality management system have the capacity and competence to undertake assessments and the processes they use meet the relevant regulatory requirements. After successful designation, the MHRA monitors UK approved bodies’ activities including by regular audits and by witnessing some of their audits of manufacturers. #MHRA #uk #medicaldevice #regulatoryaffairs #regulatory #regulation

Hello dear followers! It was released the "MDCG 2024-10 - Clinical evaluation of orphan medical devices". The document provides guidance to manufacturers and notified bodies on the clinical evaluation pursuant to the MDR of medical devices and accessories for medical devices that qualify as ‘orphan devices’ (OD) and medical devices and accessories for medical devices that have an orphan indication, within the meaning of this guidance. This guidance is relevant to devices across all risk classes as per the classification rules defined in the MDR. This guidance gives particular attention to the clinical evaluation and investigation requirements stated in MDR Chapter VI and Annex XIV for these devices. Where relevant, this guidance should be read in conjunction with other MDCG guidance on the clinical investigation and evaluation of medical devices, including MDCG 2020-5, MDCG 2020-6, and MDCG 2023-7. Custom-made devices, in-house devices, products without an intended medical purpose listed in MDR Annex XVI and in vitro diagnostic medical devices are outside the scope of this guidance. Source: https://lnkd.in/dmUF9BEx #mdcg #mdr #manufacturer #notifiedbody #orphandevices #Clinicalevaluation #regulatoryaffairs #qualityassurance #vlfconsulting