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EU Health Data Space Regulation: What It Means for Medical Device Manufacturers The European Health Data Space (EHDS) Regulation is here, transforming how health data is accessed, shared, and used across the EU. For medical device manufacturers, this means new interoperability requirements, stricter data governance rules, and exciting opportunities to leverage real-world health data for research and AI-driven innovation. Manufacturers of digital health and connected medical devices must ensure compliance with EHDS data-sharing frameworks, enhancing cybersecurity and aligning with EU regulations like the MDR/IVDR and GDPR. The EHDS opens doors for access to anonymised health data, helping to refine AI algorithms and support better patient outcomes. But with new opportunities come challenges—companies must adapt quickly to evolving regulatory demands while ensuring transparency and security. As the EHDS rolls out, manufacturers should proactively engage with regulators, update compliance strategies, and prepare for a more connected, data-driven future in healthcare. #EHDS #HealthData #MedicalDevices #DigitalHealth #Regulation

Why choose Specculo? Hear it from one of our satisfied clients who would recommend Specculo to "anyone looking for reliable and swift EU compliance support." It's been a pleasure supporting eargym | B Corp in achieving their goals. Reach out to find out how we can make what might seem to be a complicated task "incredibly straightforward". Wait no further and visit https://lnkd.in/e-EwaEyC today. #Specculo #Testimonial #ClientFeedback #SuccessStory #SatisfiedClient #BusinessGrowth #EUMDR #CEMark #MedicalDevices #EUAuthorisedRepresentative

📢 MDCG 2023-3 Rev. 2 The MDCG has just released another revised version of MDCG 2023-3 on Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746. Revised highlights include: ⭕ Question 1: Footnote 8 has been updated to align with Regulation (EU) 2024/1860, addressing the gradual roll-out of Eudamed, supply interruption obligations, and transitional provisions for specific in vitro diagnostic devices. ⭕Question 21: References to the “Eudamed vigilance (VGL) module” are now updated to “Eudamed Postmarket Surveillance and Vigilance module (VGL module)” for consistency with system terminology. ⭕Footnote 34: The timeframe “48 working hours” has been clarified as “48 hours (equivalent to two weekdays)” to ensure clarity for reporting timelines. #MedicalDevices #IVDR #MDR #Eudamed #Vigilance #RegulatoryUpdates #MDCG

🚨 Attention Medical Device Manufacturers and Stakeholders 🚨 A critical deadline is fast approaching! As of January 10, 2025, the new Article 10a of the EU Medical Device Regulation (MDR) will officially come into effect. Manufacturers will be required to: ✅ Notify competent authorities and stakeholders at least 6 months in advance of any anticipated supply interruption or discontinuation for certain medical devices or in vitro diagnostic devices (IVDs). ✅ Ensure timely and detailed communication to mitigate risks to patients and public health. We've just published an article (link in comments) providing more detail on Article 10a and obligations of the various stakeholders. Reach out to ensure you're prepared for the January 10, 2025, deadline. #MedicalDevices #EUMDR #RegulatoryCompliance #Healthcare #Article10a #IVDR #PatientSafety #EURegulations #SupplyChainManagement

🎉 Happy New Year from Specculo! 🎉 As we kick off 2025, we want to wish all our clients and followers a year full of success and prosperity! Thank you for your continued support – we couldn’t have done it without you. Looking ahead, we’re excited for what’s to come in 2025: 🔹 Expanded services to cover more jurisdictions. 🔹 Key regulatory deadlines: Jan 10: Enhanced notification requirements for supply chain disruptions. May 26: IVDR deadlines for QMS & legacy product conformity assessments. Sep 26: IVDR notified body agreements. 🔹 Anticipating new MDCG guidelines, especially for Clinical Evaluations. We’re also starting the year with a new registered address: 📍 10/1 Sir M.A. Refalo Avenue, Balzan BZN1600, Malta 💬 And we're now also available on WhatsApp: +356 7900 6716 What are you looking forward to in 2025? #HappyNewYear #MedicalDevices #EUCompliance #Specculo #RegulatoryUpdates

MDCG 2024-16 Manufacturing Information Form has been published. The Manufacturer Information Form (MIF) is required under Article 10a of Regulation (EU) 2024/1860. This form is a crucial tool for manufacturers to notify competent authorities about anticipated supply interruptions or discontinuations of medical devices and IVDs. Here’s what you need to know: ✅ Purpose: Standardises notifications to competent authorities, ensuring consistent and actionable communication across the EU. 📋 Key Details Required: - Device identification (e.g., Unique Device Identifier). - Description and timeline of the supply disruption. - Reasons for the interruption (e.g., regulatory, manufacturing, supply chain). - Mitigation actions, such as stockpiling or alternative solutions. 📅 Effective Date: Manufacturers must use the MIF starting 10 January 2025 for mandatory notifications. Early voluntary notifications are encouraged for proactive compliance. 💡 Next Steps: Ensure your teams are familiar with the form's requirements and implement internal systems to monitor and assess potential supply risks. Stay ahead of these regulatory changes! For guidance on Article 10a compliance and navigating EU medical device regulations, connect with us at Specculo Limited. #MedicalDevices #IVDR #MDR #RegulatoryUpdates #EUMarketCompliance

📢 MDCG 2024-15: Publication of Clinical Investigation Reports in the Absence of EUDAMED MDCG 2024-15 establishes procedures for submitting and publishing clinical investigation reports and their summaries while EUDAMED is not fully operational. Key highlights include: ✅ Sponsors must submit reports and summaries to national competent authorities, which will then forward them to the European Commission. ✅ Documents will be stored and made publicly accessible via a dedicated CIRCABC directory to ensure transparency. ✅ Labeling and tracking protocols are established, using CIV-IDs for clear identification. ✅ Summaries must be easily understandable and prepared following Commission guidelines. ✅ This process will remain valid until the mandatory use of the EUDAMED CI/PS module is implemented. This guidance reinforces the commitment to public access and regulatory transparency in clinical investigations under the EU MDR. 📖 Access the full document document for all procedural details below. #ClinicalInvestigations #MDR #Transparency #MedicalDevices #Compliance

📢 New Guidance Released: MDCG 2024-14 on Master UDI-DI for Contact Lenses MDCG 2024-14 has recently been published. It's a critical guidance document addressing the implementation of the Master UDI-DI for contact lenses under Regulation (EU) 2017/745 (MDR). This document provides manufacturers with clear instructions on: ✅ Assigning Master UDI-DIs for both standard and made-to-order contact lenses. ✅ Labelling and packaging requirements to enhance traceability. ✅ Vigilance reporting protocols using Eudamed. ✅ Key timelines, including the mandatory application date of November 9, 2025. This guidance represents a significant step forward in improving traceability and compliance for highly individualised medical devices like contact lenses. 📖 Read the full document and ensure your processes are aligned ahead of the transition period. #MedicalDevices #EUMDR #UDI #ContactLenses #Regulation #Compliance #Traceability

The European Parliament requests urgent revisions to the EU MDR and IVDR due to significant implementation challenges and patient access issues. We’ve all experienced it: Delayed applications, contradictory assessments, different weights and measures, and the various articles tackling “Why you should prioritise US compliance before EU”. Revising the regulatory framework for streamlined processes, improved support for SMEs, and fast-track approvals for life-saving technologies. These are the changes we’d all like to see and be apart of. We’ll be watching end of Q1 2025 with interest as this is the requested deadline by when the proposed delegated acts should be presented. Link to the request in the comments below. #MedicalDevices #EURegulation #HealthcareInnovation #PatientSafety"

Our clients' satisfaction is our success 🙏😊⬇💛 #specculo #medicaldevices #EUMDR #CEMark #testimonial #satisfiedclient