Medtech & Pharma Platform Association’s Post

Just In ➡ Regulation (EU) 2024/1860 has been published in the Official Journal of the European Union (OJEU) The regulation adopted today amends the legislation on medical devices, including in-vitro diagnostic medical devices (IVDs), by: • Further extending the transition period for certain IVDs • Enabling a gradual roll-out of EUDAMED, the new electronic database • Requiring manufacturers to flag up potential shortages of critical medical devices and IVDs Conditions: Only IVDD legacy devices may benefit from the extended transition period if: • The device continues to comply with IVDD requirements • There are no significant changes in design or intended purpose of the device • The device does not present an unacceptable risk to the health and safety of patient • The manufacturer has implemented an IVDR compliant QMS no later than 25 May 2025 • The manufacturer has lodged a formal application with a NB by May 2025 for IVDD certified and class D self-declared devices, by May 2026 for Class C self-declared IVDs and by May 2027 for class B and A-Sterile self-declared IVDs • The manufacturer has signed a written agreement with a NB by September 2025 for IVDD certified and class D self-declared devices, by September 2026 for Class C self-declared IVDs and by September 2027 for class B and A-Sterile self-declared IVDs If the above conditions are met the following transitional period for IVD devices can be utilized: • 31 December 2027, for class D devices; • 31 December 2028, for class C devices; • 31 December 2029, for class B devices and for class A devices placed on the market in sterile condition #IVDR #EU #Transitionalperiod #EUDAMED #Regulatoryupdates

📢 Medical Devices Update: New Guidelines for Medical Device Labeling! 🌐 The International Medical Device Regulators Forum (IMDRF) has released a new document outlining the principles of labeling for medical devices, including those for in-vitro diagnostics (IVDs). 👉 This document aims to standardize the content and format of medical device labeling, which can be presented in paper or electronic form. It covers general labeling principles and includes specific sections on the label itself, instructions for use, and patient information. 👉 It's important to note that this document provides general guidelines and doesn't cover everything. Manufacturers should also consider the requirements of any relevant medical device or IVD medical device-specific standards. Additionally, advertising and promotional materials are not included in the scope of this document, and individual regulatory authorities may have their own requirements for these elements. 💡 This new guidance promotes clear and consistent labeling for medical devices worldwide, which can ultimately improve patient safety and device use. 🔎 Know more about our expertise for medical devices and IVDs labeling at: https://lnkd.in/dt4tQYNy #IVD #InVitroDiagnostic #RegulatoryAffairs #IVDR #EuropeanRegulations #RegulatoryCompliance #MedicalDevicesManufacturers #MedicalDevicesRegulatorySupportUnit #MDRu Sandra Balseiro Ana Brito Celeste Oliveira Natalia de Souza Lescura Raquel Gomes Viviana Gomes Luiz de Pádua Queiroz Júnior Ana Catarina Silva

The EU Commission has adopted new regulations for in vitro diagnostic medical devices (IVDR), extending transitional periods for market access. Manufacturers must notify authorities of any supply shortages. The EUDAMED database accelerated rollout begins in Q4 2025. Need support navigating these changes? Contact our Senior Advisor Mette Hassan for expert guidance! #IVDR #MedicalDevices #EUCompliance #EUDAMED #RegulatoryUpdates #Mericon

#PollResult Innovation in Medical Devices: The Role of Notified Bodies Innovation is central to most manufacturers’ strategies. Working with a Notified Body with a broad scope of designations and accreditations is one key success factor; this fosters confidence in innovation and optimizes the time to market for medical devices while minimizing change-associated risks. We recently asked you via LinkedIn about the percentage of codes covered by GMED under the MD and IVD regulations, and the majority of respondents found the right answer: 93%! We cover 65 out of 71 MDR codes and 80 out of 80 IVDR codes, which confers an extensive strategic advantage for manufacturers who trust us with their certification projects. #MDR #IVDR #MedicalDevices #Certification #RegulatoryCompliance

Navigating the Slow Transition: Key Insights on the Updated EU Medical Device Regulations and EUDAMED Implementation The 2017 EU regulations for medical devices and IVDs aimed to modernize the sector, enhance patient safety, and improve transparency. Despite the urgent need for updated oversight, the transition has been slow. Petra Zollner, Director of Regulatory Affairs at MedTech Europe, and Richard Houlihan, CEO of EirMed, discuss the ongoing challenges. Zoellner points out that the system remains "unpredictable, slow, complex, and unclear," impacting both large manufacturers and SMEs. The bottleneck in conformity assessments and delayed EUDAMED implementation have further complicated compliance efforts. Research shows that 54% of medical device manufacturers and 22% of IVD tests may be discontinued, with many companies prioritizing markets outside the EU. This impacts patient care, as clinicians report shortages of essential devices. The European Commission’s new proposal extends transition periods and mandates the gradual rollout of EUDAMED. While supportive, MedTech Europe emphasizes the need for improved efficiency and clearer timelines. Manufacturers must act now: prioritize EUDAMED compliance and communicate challenges to authorities. By staying informed and proactive, we can navigate these changes and continue to innovate within the EU market. https://lnkd.in/ebzhkHsE 📰 Stay ahead of the curve by following Practical Patient Care on LinkedIn for more industry news and insights. You can also access our latest edition here: https://lnkd.in/guUBWkRE #PracticalPatientCare #MedicalDevices #EUDAMED #IVDR #RegulatoryAffairs #HealthcareInnovation

📣📢The Regulation that MD/IVD manufacturers have been waiting for! On July 9th, the Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of EUDAMED, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices has been published in the OJEU. The aim of the regulation is to mitigate shortages of critical medical devices. The new regulation amends the current legislation on medical devices, including in vitro diagnostic medical devices (IVDs), by: ▪️ Enabling a gradual roll-out of EUDAMED, the new electronic database – new timeline also published! Check it out at the following link: [Link] ▪️ Requiring manufacturers to inform stakeholders about potential shortages or discontinuation of supply in the market of critical medical devices and IVDs 6 months in advance (New article 10a) – Applicable from 10 January 2025, meaning it is now time for manufacturers to start preparing. ▪️ Further extending the transition period for IVDDs legacy devices. Verify the conditions for the extension: 👉If there are no significant changes in design or intended purpose; 👉 If the devices do not pose an unacceptable risk to patients; 👉 If the Manufacturer’s QMS is implemented by 25 May 2025; 👉If the Manufacturer has first submitted a formal application to a Notified Body; 👉 If the Manufacturer has finally signed a written agreement with a Notified Body. 📧 Owlpharma is here to support with the new regulation and help your medical device meet compliance. #Owlpharma #MedicalDevices #Regulation #News #EUDAMED #OJEU #IVDS

MedTech Europe has published the results of their latest survey into the status of MDR and IVDR at manufacturers. Key Findings: Shift in Manufacturer Concerns: While finding a Notified Body is less of an issue, uncertainty around costs, timelines, and predictability remains, risking Europe’s attractiveness for innovative devices. Conformity Assessment Efficiency should be improved: Over 50% of conformity assessment time is spent outside the review phase. Streamlining pre-review and certificate issuance could reduce total assessment time. Increased Costs for Manufacturers: Rising costs in clinical evaluations, Post-Market Surveillance (PMS), and certification are challenging manufacturers, with variability across Notified Bodies complicating financial planning. Long-Term Financial Strain: By the end of a five-year certification cycle, IVD manufacturers will spend 70% more on maintenance and re-certification, while MD manufacturers face a 50% increase. https://lnkd.in/eb-fdxqZ

The European Commission published Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 "amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices" This legislative act provides that legacy IVDD devices may benefit from the extended transition period only if - the device continues to comply with IVDD requirements - there are no significant changes in the design or intended use of the device - the device does not present an unacceptable risk to patient health and safety - the manufacturer has implemented an IVDR-compliant QMS by 25 May 2025 - The manufacturer has submitted a formal application to a Notified Body by May 2025 for IVDD certified and self-declared class D devices, by May 2026 for self-declared class C IVDs and by May 2027 for self-declared class B and A-terile IVDs - The manufacturer has signed a written agreement with a notified body by September 2025 for certified IVDD and self-declared Class D devices, by September 2026 for self-declared Class C IVDs and by September 2027 for self-declared Class B and A-terile IVDs. If the above requirements are met, the transition period is extended to: - 31 December 2027 for certified IVDDs and self-declared Class D devices - 31 December 2028 for self-declared Class C devices - 31 December 2029 for self-declared Class B and Class A devices. Source: https://lnkd.in/epV2RwXM #ivdd #ivdr #regulationeu #extendedtransitionperiod #EuropeanCommission #regulatoryaffairs #qualityassurance #vlfconsulting

26 April 2024 Final Document IMDRF/GRRP WG/N47 FINAL:2024 (Edition 2) Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices. Scope: The purpose of this IMDRF guidance is to provide harmonized Essential Principles that should be fulfilled in the design and manufacturing of medical devices and in vitro diagnostic (IVD) medical devices to ensure that they are safe and perform as intended. The worldwide adoption of a common set of fundamental design and manufacturing requirements for medical devices that, when met, provide assurance the device is safe and performs as intended, offers significant benefits to, among others, manufacturers, users, patients/consumers, and to Regulatory Authorities. Reducing differences between jurisdictions decreases the cost of gaining regulatory compliance and allows patients earlier access to new technologies and treatments. This document has been developed to encourage and support global convergence of regulatory systems. It is intended for use by Regulatory Authorities (RAs), Conformity Assessment Bodies (CABs), industry, and other stakeholders, and will provide benefits in establishing, in a consistent way, an economic and effective approach to the control of medical devices in the interest of public health. It seeks to strike a balance between the responsibilities of RAs to safeguard the health of their citizens and their obligations to avoid placing unnecessary burdens upon the industry #wyrobymedyczne #medicaldevices #mdr #ivdr #medtech #conformityassessment

EU MDR News!! (Orphan Medical Devices) Today (25-June) the Medical Device Coordination Group (MDCG) has published "MDCG 2024-10 Clinical evaluation of orphan medical devices" This 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. The document is divided into two parts: • Part A: Clinical considerations for orphan devices, including acceptable limitations in pre-market data, key considerations for evaluation, and generating post-market data. • Part B: Procedural considerations for notified bodies, including assessment of orphan devices and the role of expert panels. There are also three appendices with specific guidance on clinical evaluation reports, clinical investigations, and extrapolating clinical data for orphan indications. For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us.   #intelligence #notifiedbody #notifiedbodies #audit #medboard #medicaldevices #medtech #euivdr #hospital #medicaldevice #medicaldevices #surveillance #automation #regulatoryintelligence #clinicalinvestigations