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𝐌𝐃𝐂𝐆 𝟐𝟎𝟐𝟐-𝟗 / 𝐑𝐞𝐯.𝟏 𝐀𝐩𝐫𝐢𝐥 𝟐𝟎𝟐𝟒 IVDR Regulation (EU) 2017/746 requires that the manufacturer shall draw up a 𝐒𝐮𝐦𝐦𝐚𝐫𝐲 𝐨𝐟 𝐒𝐚𝐟𝐞𝐭𝐲 𝐚𝐧𝐝 𝐏𝐞𝐫𝐟𝐨𝐫𝐦𝐚𝐧𝐜𝐞 (𝐒𝐒𝐏) for class C and D devices, other than devices for performance studies. The document provides the latest and helpful template for creating a SSP for in vitro diagnostic medical devices. The SSP shall be validated by a notified body (NB) and made available to the public via the European database on medical devices (Eudamed). This guidance is essential for maintaining transparency and safety in the deployment of medical devices across Europe. Manufacturers must keep the SSP updated in line with any changes from post-market performance or safety evaluations.   #invitrodiagnostics #medicaldevices #regulatoryaffairs #regulatorycompliance #medtech #eudamed

The European Commission is extending its ongoing "scientific advice" pilot for high-risk devices to a third phase, according to an update on its website (https://lnkd.in/gT6ve8vT). It sets a new June 30 deadline for companies to apply to participate in the program where expert panels give companies feedback on clinical investigation plans to support EU Medical Device Regulation submissions. One notable addition for 3rd phase: companies are invited to indicate "if they would be willing to have an HTA body observe their project," linking the effort to the EU's impending HTA regulation. Meanwhile, one type of body yet to be invited to participate: notified bodies, which are the ones that ultimately have to review this clinical data for MDR. (https://lnkd.in/gqduUgDX) #medtech #regulation

🔍 Regulatory Update: EUDAMED Implementation 🔍 Breaking news from the European Commission! The proposed measures for the In Vitro Diagnostic Medical Devices Regulation (IVDR) aim to improve patient care and enhance transparency in the Medical Device sector. Key highlights include a revised timeline for compliance, ensuring essential healthcare products remain available. 📅 Timeline Extension: High-risk IVDs get a transition period until December 2027, moderate risk until December 2028, and lower risk until December 2029. Learn more about the specifics below. 🌐 Transparency Boost: The launch of the European Database on Medical Devices – EUDAMED is set to become mandatory earlier, by late 2025. This move will provide a comprehensive overview of all medical devices in the European market. Stay informed and stay compliant! 💡 #IVDR #EUDAMED #RegulatoryUpdate #MedTech #MedicalDevices #ComplianceMatters

Breaking news! After the extended transitional provisions for certain Medical Devices with the adoption of Regulation (EU) 2023/607, the European Commission (EC) now also proposed to extend the transitional provisions for certain IVD devices. Secondly, the EC aims on gradually rolling-out EUDAMED, and make certain modules mandatory prior to all six modules being completed. Originally, EUDAMED would only come into effect (mandatory) once all six modules would be completed. Emergo by UL keeps you informed on further developments and what this proposal entails for you. #marketaccess #ivdr #eudamed #europeancommission

Stay informed about the dynamic changes in the medical device regulatory industry. Explore these latest news updates: • EU Regulation 2024/1860: Key Changes for IVDR Compliance • Regulation (EU) 2024/1860: IVDR Extended Transition Periods • Updated EUDAMED Timeline for Modules • MDCG 2020-16 Guidance: Classification Rules for IVDs • WHO and GMDN Medical Device Collaboration for Communication For more information on these updates, click here: https://bit.ly/3WJ6NlE #RegulatoryNews #RegulatoryUpdates #MedicalDevice

As we conclude the year, let us reflect upon the significant milestones in the regulatory landscape of Medical Devices. In December, ANVISA ushered in Resolution RDC 837/2023, charting a clear course for clinical investigations, crucial for registering class III and IV medical devices. Simultaneously, strict standards were set for in vitro diagnostic devices. Fast forward to August, and ANVISA opened new avenues by permitting the importation of medical devices, even those predating notification, fostering accessibility. Explore our brochure for an in-depth look at these key regulatory strides shaping the future of Medical Devices! For more information, please visit:   #MedicalDevices #RegulatoryReview #2023Highlights

🚨 IVDR Compliance Deadlines Extended! 🚨 Great news for the MedTech community! The EU Commission has announced an extension for the In Vitro Diagnostic Medical Devices Regulation (IVDR) with Regulation (EU) 2024/1860, effective July 9, 2024. This extension gives manufacturers and notified bodies additional time to comply with IVDR requirements for legacy devices. Key Deadlines: Risk Class D: Until December 31, 2027 Risk Class C: Until December 31, 2028 Risk Class B & Sterile Class A: Until December 31, 2029 Conditions for Extension: Maintain compliance with Directive 98/79/EC No significant changes to devices Ensure no unacceptable risk to health and safety Establish a quality management system by May 26, 2025 Submit formal applications for conformity assessments within specified deadlines For more details, read the full regulation and Q&A: Link to Regulation 🔍 Looking for Expert Guidance? The Arazy Group is here to help you navigate these changes and ensure your devices meet all regulatory requirements. Reach out to our helpful experts today! https://hubs.ly/Q02GPc860 #IVDR #MedicalDevices #EURegulations #HealthcareInnovation #MedTech #RegulatoryAffairs #PatientSafety #Compliance #QualityManagement #ArazyGroup

❗ Two newly revised #Guidance documents endorsed by the Medical Device Coordination Group (#MDCG) have been published today on the European Commission EU Health and Food Safety DG #SANTE website on the #Regulations on #MedicalDevices (#MDR) and #InVitroDiagnosticMedicalDevices (#IVDR) on "Public Health > Medical Devices - Sector > New Regulations > Guidance" https://lnkd.in/e3jct9JG: ▶ MDCG 2021-27 - Rev.1 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 https://lnkd.in/epFdVTBV ▶ MDCG 2019-7 - Rev.1 Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC) https://lnkd.in/eeSvGtjp

Breaking: Commission proposes to extend transition periods for certain IVDs, gradual roll-out of Eudamed and an information obligation in case of interruption of supply. "This proposal for targeted amendments addresses two urgent issues. Firstly, it aims to further extend the transitional period for certain IVDs to mitigate the risk of shortages of these products, especially of high-risk IVDs, which are used, for example, to test for infections in blood or organ donations or for blood grouping for transfusions.  Secondly, the proposal aims to enable a gradual roll-out of the electronic systems integrated into the European database on medical devices (‘Eudamed’) that are finalised, instead of deferring the mandatory use of Eudamed until the last of the six modules is completed. The use of Eudamed – and especially its systems for the registration of economic operators, devices and certificates – will improve transparency and provide information on devices on the EU market, helping to monitor the availability of devices. In addition, the proposal aims to impose a requirement on manufacturers to give prior notice before interrupting the supply of certain critical medical devices and IVDs." #medicaldevices #invitrodiagnostics #medtech #EUMDR #EUIVDR #EUDAMED #supplychainmanagement

Time really is running out for certification of Class D IVDs under the #IVDR by 26 May 2025 if they are currently on the market under the IVD Directive (#IVDD)... As highlighted by Amanda Maxwell, a speech at the latest EPSCO Council meeting has raised concern over the Class D/high risk device deadline in 2025: 'There are more than 1,000 high-risk in vitro diagnostics on the market. According to data from October, manufacturers submitted 335 applications for high-risk in vitro diagnostics and notified bodies have issued only 109 certificates. Certification takes around 18 months. These numbers are worrying and we are collecting more data to have a clear picture.' Source 30-Nov Press Release: https://lnkd.in/eM3CwJZZ #IVDs #IVDR #ClassD #26May2025 #timecritical