Letter from the HMA Core Group for Medical Devices to the European Commission Correspondence emphasizes the readiness of the national authorities responsible for #medicaldevices to collaborate with the #EuropeanCommission and relevant partners to address the challenges identified within the current regulatory framework. It highlights the urgent need for thoughtful and deliberate action, particularly in light of recent discussions in the #EuropeanParliament regarding the revision of medical device legislation. The letter articulates concerns about the potential for hastily expedited amendments that may further complicate the regulatory landscape and may have unintended impact on public health. It underscores the necessity for comprehensive analysis and impact assessments, including the Commission's ongoing targeted evaluation, to ensure that any legislative changes are aligned with core objectives and do not inadvertently create further challenges. The Competent authorities remain committed to identifying actions that can be taken in the short and medium term to address, at least in part, the issues and concerns raised by stakeholders. They will continue to work intensively with relevant teams in progressing these in the short term and in advance of completion of the targeted evaluation. Link: https://lnkd.in/d2yufzy6 #wyrobymedyczne #medicaldevices #medtech #ham #ema #mdr

Three revised and updated #Factsheets has been published on the European Commission EU Health and Food Safety DG #SANTE webpage on the #EU #Regulations on #MedicalDevices (#MDR) and #InVitroDiagnosticMedicalDevices (#IVDR): ✅ "Factsheet for Procurement Ecosystem of medical devices and in vitro diagnostic medical devices" https://lnkd.in/eKtAjQjX ▶️ "Factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices" https://lnkd.in/ebcFeskQ ☑️ "Factsheet for healthcare professionals and health institutions" https://lnkd.in/etn_2SJD

“Extraordinary! Not a word for consumers or patients. Still no #Eudamed! And “getting ready” for what? Another decade of delays? The entire #CE process needs a complete and thorough overhaul - including a massive shake up at the #EuropeanCommission to ensure the patient centric purpose of regulation is recognised as a public duty and proven patient safety the only route to successful entry onto the EU and global markets. The value and reputation of the CE mark suffers along with patients, health professionals and institutions. The rich and powerful industry lobbies that use the regulations to avoid #recalls, #postmarketsurveillance, scientific #clinicalevidence, responsible #AdverseEvent monitoring are depending on the regulatory authorities failing in their responsibilities and duties, and failing to recognise the emerging economic disaster, built on fabricated safety claims and shady stakeholder Forward Statements and manipulated data. Governments can continue at the mercy of these industries which enjoy bizarre freedoms from prosecution or accountability, or they can take action.” Eleos Fry Global Game of Implants EU Medicines and Medical Devices Regulations Robert F. Kennedy

What is one of a total of 35 #regulatory and policy items captured on Document Depot in June, including six published by the European Commission (see infographic below)? The EU orphan device guidance. Guidance documents are principally a mechanism for government bodies to explain how existing policies will be implemented and enforced. But in some cases, regulatory agencies can stretch the functions of guidance, using them as a means to more broadly interpret existing authorities to establish new policies that aren’t explicitly spelled out in law, regulation, or other decree. Orphan devices, or devices addressing rare diseases or subpopulations, are not mentioned as an explicit product category in the MDR. But device makers and public health advocates alike have been complaining since the MDR was enacted about its lack of consideration for products targeting patients struggling with conditions where the population numbers are too low to make meeting the regulation’s clinical evaluation standards feasible. The EU Medical Device Regulation doesn’t contain any special provisions for devices addressing rare diseases or subpopulations, but policymakers worked with what they have last month in a guidance document laying out an approach to allow reduced clinical requirements for orphan devices. Here’s a look at some comparisons to US humanitarian device exemptions. #medtech #medicaldevices

🚨 Attention Medical Device Innovators & Stakeholders! 🚨 The UK government is seeking YOUR input on important regulations impacting medical devices and in vitro diagnostic devices. This consultation is a key opportunity to help shape the future of the sector and ensure that the UK continues to foster a regulatory environment that supports innovation while safeguarding public health. 🔍 Why should you participate? Influence regulatory pathways for medical devices and diagnostics. Contribute to policies that will impact market access and the compliance process. Share your expert feedback on how to improve the framework for bringing life-changing devices to market. Your insights can make a real difference in streamlining processes, improving efficiency, and ensuring the regulations are fit for the rapidly evolving medical device industry. 👉 How to Get Involved: Visit the consultation page here: Consultation on Medical Devices Regulations: https://lnkd.in/da-mUgRa 📅 Deadline: Be sure to submit your views by the closing date to have your voice heard. Let's ensure the UK remains at the forefront of medical innovation and patient safety! #MedicalDevices #Innovation #HealthcareRegulations #IVDs #UKRegulations #MedicalTechnology #PolicyConsultation #HealthcareIndustry

Regulatory compliance for successful clinical evaluations of medical devices is a complex process. It involves considering the use of real-world data, understanding how a device benefits patients, and curating peer-reviewed clinical literature to support approvals. Learn more in our latest interview with Asha Jacob. https://hubs.ly/Q02JbWDS0

✳ Interesting discussion paper from the FDA about Health Equity for Medical Devices. ➡ All signs point to a significant new priority at the FDA when evaluating a pre-market submission. ❓ Does your data sufficiently address safety and effectiveness across all segments of the intended use population? 💥 There are some who think that FDA should not approve/clear devices that are not supported by clinical data from a sufficiently representative population. ➡ While this is an extreme position, it does represent a clear gap, and frustration - case in point, the recent issue with pulse oximeters that were not accurate on patients with darker skin tones. ❓ How can risk and regulatory professionals lead this discussion within their organization? 👇 Share your thoughts in comments below. =================================== 💕 this post? ♻ Repost to share with others in your network. #letstalkrisk #regulatoryaffairs #medicaldevices

🚨 Urgent Call to Revise the Medical Devices Regulation! 🚨 The European Parliament has recognized the pressing need to revise the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) to ensure the safety and accessibility of essential medical devices across the EU. 🔍 Key Highlights: Access Disparities: Significant disparities in access to medical devices persist, impacting patient care and health equity. Regulatory Challenges: While the MDR and IVDR aim to enhance safety and transparency, many stakeholders, especially SMEs, face challenges navigating complex regulations, leading to delays and shortages. Need for Innovation: The regulatory frameworks must better accommodate innovative technologies, especially in areas of unmet medical need. 📢 The Parliament urges the Commission to: Propose necessary revisions by Q1 2025. Streamline regulatory processes to improve transparency and reduce administrative burdens. Ensure timely market access to life-saving devices, prioritizing innovative solutions. We will keep you posted with this new development. Don't forget to follow Sushvin Consultancy Services for more such insightful updates! #MedicalDevices #Healthcare #EURegulations #Innovation #PatientSafety #HealthEquity #EUMDR #EUIVDR #RegulatoryUpdate

Is your medical device ready for clinical trials in the UK? Understand the MHRA's notification requirements and streamline your process. Our new blog provides essential guidance. https://lnkd.in/gjV-xQ-4 #MHRA #ClinicalTrials #MedicalDevice #RegulatoryAffairs

5 Key points of the European Parliament resolution of 23 October 2024 on the urgent need to revise the Medical Devices Regulation (2024/2849(RSP))! The 5 key points are: 1. Streamlining the Regulatory Process: The European Parliament calls on the Commission to use legislative and non-legislative tools to resolve issues of divergent interpretation and practical application. This aims to streamline the regulatory process, improve transparency, and eliminate unnecessary administrative work for notified bodies and manufacturers, particularly SMEs, without compromising patient safety. 2. Transparent and Binding Timelines: The document advocates for the creation of transparent and binding timelines, including clock stops for procedural steps in conformity assessment by notified bodies. This is intended to create predictability and certainty for manufacturers regarding the market access procedure and its duration within the EU. 3. Addressing Re-Certification Issues: The resolution stresses the need to eliminate unnecessary re-certification of products. It underlines that certain product updates or adjustments should not necessarily lead to an entire re-certification of the product. This aims to harmonize provisions and ensure consistency across the EU. 4. Fast-track Approval for Innovative Technologies: The European Parliament strongly calls on the Commission to consider fast-track and prioritization pathways for the approval of innovative technologies in areas of unmet medical need and for devices linked to health emergencies. 5. Support for SMEs and Orphan/Pediatric Devices: The document recognizes the challenges faced by SMEs in adapting to the new legal frameworks. It calls for the development of specific measures to support SMEs, including the provision of model application documents, forms, regulatory guidance, and other assistance to reduce costs and complexity. Additionally, it calls for adapted rules and more efficient conformity assessment procedures for orphan and pediatric medical devices, without compromising patient safety. #regulatoryglobe #mdr #medicaldevices