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Last Updated on: 09. Nov 2024 New harmonized standard for MDR: Decision ✅ 26 out of 226 standards harmonized (11.5%) New harmonized standards for IVDR: Decision ✅ 15 out of 45 standards harmonized (33.3%) Note: The harmonization of norms regarding the regulations MDR and IVDR is still ongoing. Therefore, this list is not exhaustive and may change over time. It is recommended to keep up-to-date with the official websites of relevant standardization bodies and notified bodies to obtain the most current information. Most of the european harmonized standards for medical devices are also mentioned by other international authorities. See here for further information. #1 Harmonized Process Standards MDR and IVDR #2 MDR Current harmonized standards All Process standards you need for your MDR and IVDR QMS (not all harmonized) CEN Reference Standard Number, and SNV Reference Standard Title MDR harm. Date IVDR harm. Date EN ISO 13485:2016, EN ISO 13485:2016/A11:2021 SN EN ISO 13485:2016 , SN EN ISO 13485:2016/A11:2021 Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) OJ L 138 – 17/05/2022 OJ L 135 –12/05/2022, incl. A11 corresponce of to IVDR/MDR. Learn more about this standard  here . EN ISO 14155:2011+AC:2011  Clinical investigation of medical devices for human subjects – Good clinical practice  not harmonised yet, new version published   ISO 14155:2020 EN ISO 14971:2019, EN ISO 14971:2019/A11:2021 Medical devices – Application of risk management to medical devices (ISO 14971:2019) OJ L 138 – 17/05/2022, OJ L 135 – 12/05/2022. Recommended together with ISO/IEC Guide 63 and ISO/TR 24971:2020 – Technical Report – Medical Devices Risk Management. Incl. Amendment A11with IVDR/MDR  correspondence. n/a Medical devices — Guidance on the application of ISO 14971 (ISO/TR 24971) not on the harmonization plan, but essential for the application of ISO 14971:2019 Already in ColabON EN IEC 62304:2006+A1:2015 CSV Medical device software – Software life-cycle processes  not harmonised yet, essential for SW Products EN IEC 62366-1:2015+AC:2016 CSV Medical devices – Application of usability engineering to medical devices  not harmonised yet, but essential EN ISO 20916:2024 In vitro diagnostic medical devices  – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916:2019) NEW harmonized since 8. November 2024 for IVDS IEC 80001-1:2011 Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software  – Part 1: Application of risk management not harmonised yet, new international standard published IEC 80001-1:2021 IEC 81001-5-1:2021 Health software and health IT systems safety, effectiveness and security – Part 5-1: Security – Activities in the product life cycle (IEC 81001-5-1) not harmonised yet, international edition published: IEC 81001-5-1:2021 IEC 82304-1:2017 Health Software  – Part 1: General requirements for product safety not harmonised yet. IEC 82304-1:2016   enlarges process requirements for healthcare software, e.g. software not being medical device or ivd The Standard Harmonization Plans Mandate M/575 - C(2021)2406 : 2021-03-12 M/575 Amd 1 – C(2023)694 We have devoted significant effort to ensure the accuracy of this list, although its creation involves meticulous manual work. If you happen to spot any errors, we would greatly appreciate your feedback so that we can make the necessary corrections. We extend our gratitude to SWITEC and SNV for their invaluable expert contributions. Publications in the Official Journal Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council Amendment of 4 January 2022 to Implementing Decision (EU) 2021/1182 Amendment of 11 May 2022 to Implementing Decision (EU) 2021/1182 Amendment of 4 July 2023 to Implementing Decision (EU) 2021/1182 Amendment of 6 March 2024 to Implementing Decision (EU) 2021/1182 COMMISSION IMPLEMENTING DECISION (EU) 2024/2631 of 8 October 2024 Current MDR List of Harmonized Standards (Status 8. Nov 2024) Here is the consolidated list of harmonized standards for medical devices No Reference of the standard Comment 1. EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)   2. EN ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) EN ISO 11135:2014/A1:2019 Published as European Amendment A1:  SN EN ISO 11135/A1:2020   3. EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) EN ISO 11137-1:2015/A2:2019 Published as: SN EN ISO 11137-1/A2:2020 Applicable for sterile packed products 4. EN ISO 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)   Published as: SN EN ISO 11737-2:2020   Applicable for sterile packed products 5. EN ISO 25424:2019 Sterilisation of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 25424:2018) EN ISO 25424:2019/A1:2022   6. EN ISO 10993-9:2021 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)   7. EN ISO 10993-12:2021 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)   8. EN ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018) EN ISO 11737-1:2018/A1:2021 Published as European Amendment A1: SN EN ISO 11737-1/A1:2021 ISO 11737-1:2018: 3rd edition 9. EN ISO 13408-6:2021 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)   10. EN ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) EN ISO 13485:2016/AC:2018 EN ISO 13485:2016/A11:2021   Amendment published as: SN EN ISO 13485/A11:2021   Applicable to all manufacturers of medical devices and ivds   Learn more about this important Amendment 11 here 11. EN ISO 14160:2021 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020)   12. EN ISO 15223-1:2021 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)   Published as full standard including the European annexes: SN EN ISO 15223-1:2021 Applicable to all manufacturers of medical devices and ivds 13. EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)   14. EN IEC 60601-2-83:2020 Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment EN IEC 60601-2-83:2020/A11:2021   15. EN 285:2015+A1:2021 Sterilization – Steam sterilizers – Large sterilizers   16. EN ISO 14971:2019 Medical devices – Application of risk management to medical devices (ISO 14971:2019) EN ISO 14971:2019/A11:2021 Amendment published as: SN EN ISO 14971/A11:2021   Applicable to all manufacturers of medical devices and ivds 17. EN ISO 10993-10:2023 Biological evaluation of medical devices – Part 10: Tests for skin sensitisation (ISO 10993-10:2021)   18. EN 455-3:2023 Medical gloves for single use – Part 3: Requirements and testing for biological evaluation   19. EN ISO 10993-15:2023 Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)   20. EN ISO 10993-17:2023 Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)   21. EN ISO 10993-18:2020 Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020) EN ISO 10993-18:2020/A1:2023   22. EN ISO 11137-2:2015 Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013) EN ISO 11137-2:2015/A1:2023   Amendment published as: SN EN ISO 11137-2/A1:2023 When your medical device is sterile packed with the sterilization method radiation 23. EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019) EN ISO 11607-1:2020/A1:2023 Amendment published as: SN EN ISO 11607-1/A1:2023 For all sterile packed medical devices 24. EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019) EN ISO 11607-2:2020/A1:2023   Amendment published as: SN EN ISO 11607-2/A1:2023 For all sterile packed medical devices 25. EN ISO 17664-2:2023 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices (ISO 17664-2:2021)   26. EN ISO 13408-1:2024 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)   Where can I find harmonised standards? Harmonised standards can be found on official websites such as the European Commission's website, which maintains a list of harmonised standards under various regulations, including the MDR (Medical Device Regulation). Additionally, harmonised standards can be accessed through national standardisation bodies such as DIN in Germany, BSI in the UK, or international bodies like ISO and CEN. These sources offer the most up-to-date versions of harmonised standards relevant to various industries, including medical devices. How to identify a harmonised standard? To identify a harmonised standard, check the official lists provided by the European Commission. A harmonised standard will have a reference number and be linked to specific EU regulations such as the MDR. It is typically prefixed by "EN" followed by the corresponding ISO or IEC number, indicating that it has been harmonised for use within the European Union to ensure compliance with regulatory requirements. Read the scope to understand the applicability... or get in touch with us... What are harmonized standards for medical devices? Harmonised standards for medical devices are specific technical standards that have been harmonised under the EU's Medical Device Regulation (MDR). These standards provide manufacturers with a clear framework to demonstrate compliance with safety and performance requirements. Common harmonised standards for medical devices include EN ISO 13485 for quality management systems and EN ISO 14971 for risk management. These standards help ensure that medical devices meet essential regulatory requirements for the EU market. What is MDR standards? MDR standards refer to the harmonised standards that support the Medical Device Regulation (MDR) in Europe. These standards cover various aspects such as quality management, risk management, biocompatibility, and clinical evaluation of medical devices. Following MDR standards helps manufacturers ensure that their medical devices comply with EU regulatory requirements, making them eligible for CE marking and placement on the European market. #harmonisedstandardsmedicaldevices #harmonizedstandardsmedicaldevices #listofharmonizedstandardsmedicaldevices #harmonisedstandardsivds #harmonizedstandardsivds Prominent Voids in Harmonised Standards Medical Device Here are a few important standards from the top of my head that are missing on the list of harmonised standards. These are quite crucial standards that have a direct impact on patient safety. 🩺 ISO 10993-1 : Biocompatibility 🧬 IEC 62366-1 : Usability 📋 IEC 62304 : Software Development 💻 IEC 60601-1 : Medical electrical equipment ⚡ IEC 60601-1-2 : EMC 🌐 Best Practices Involve your notified body early Discuss this topic with pears from other companies Use the harmonised standards whenever available, else use the FDA consensus standards ColabON: Access to all data at clause level With ColabON, you gain access to all relevant norms and regulations for the medical device / in vitro diagnostic industry in a structured and easily understandable format. The data is provided at clause level, enabling you to conduct precise and detailed analysis. Get the current and planned harmonized standard list for medical devices and ivds

The impacts of roles in quality system management  that many managers overlook but can significantly slow down your organization. 1️⃣ Reorganizations affect roles in quality system management . 2️⃣ The quality system must clearly define roles and responsibilities. 3️⃣ After a reorganization, organizational roles must align with roles in quality system management. Key takeaway When you reorganize, ensure that your organizational roles are consistent with roles in quality system management  to avoid mismatches. Benefits: 1️⃣ Less uncertainty during reorganizations. 2️⃣ Increased credibility. 3️⃣ Faster implementation—or no implementation issues—when roles in quality system management are clearly separated from organizational roles. We have built this into our tool because we have seen how much time, energy, and money is wasted during reorganizations. This is one of the key reasons why we developed ColabON AG. ColabON helps you reduce the time and effort of reorganizations by 90% Why are clear roles in quality management required? ISO 13485 Claus 4.1.1 und 5.1.1 CFR Title21 Part 820 subpart B 820.20 and many more What is a Role in the Quality Management System? A role refers to a function or responsibility of a person within the Quality Management System (QMS). Each individual can take on multiple roles within the QMS. Do not use organizational roles such as CEO, CTO, or organizational leader functions. The organization may change—don’t let this affect your Quality Management System! What Are the Most Common Mistakes? Using organizational roles such as CEO, CTO, or department heads as quality roles. Organizations evolve. Teams and structures can shift, but your QMS must remain stable to ensure compliance and effectiveness. When organizational changes affect your quality roles, it can lead to: Gaps in responsibilities. Miscommunication across teams. Reduced compliance and loss of trust during audits or inspections. How to Avoid These Issues 1️⃣ Separate quality roles from organizational roles:  Assign quality roles independently of the organizational hierarchy to maintain stability during changes. 2️⃣ Simplify reorganizations:  Clearly defining quality roles reduces uncertainty, strengthens credibility, and allows faster implementation of changes. 3️⃣ Use tools for consistency:  At ColabON, we’ve integrated these principles into our solutions. We understand how much time, energy, and money is wasted during reorganizations when quality roles are not managed efficiently. This is how ColabON's Software has efficiently implemented the Roles in Quality System Management (QMS) They are compliant with ISO/TR 24971:2020 - Technical Report on Medical Devices Risk Management.  Clause 4.3 includes examples with attributes, which we have incorporated into ColabON. By aligning quality roles with regulatory standards, ColabON ensures your processes remain compliant, effective, and ready to adapt to organizational changes. Name Responsibility Authority Competence Requirements 90% More Efficient Role changes with ColabON Don't let reorganizations derail your QMS. With clear and consistent quality roles, you ensure the integrity of your quality processes and keep your organization on track. #QualityManagement #QMS #Reorganization #QualityRoles #RolesAndResponsibilities #Compliance #MedicalTechnology #Efficiency #ColabON #InnovativeManagement #OrganizationalStructure #Digitalization #ProcessOptimization #TimeSaving #13485

SN EN ISO 13485/A11:2021 Medical devices — Quality management systems — Requirements for regulatory purposes Amendment 11 Alignment with European Compliance for MDR and IVDR It is the European addition to ISO 13485:2016. This amendment helps demonstrate conformity with the requirements of European regulations MDR and IVDR. Essentially, it explains how certain parts of the MDR and IVDR can be fulfilled through the application of SN EN ISO 13485. When was ISO 13485 last updated? The international standard organization (ISO) published the latest international edition of ISO 13485 in 2016. And this international part remains unchanged . The European Union published EN ISO 13485/A11:2021 in 2021. However, EN standards are not available for direct purchase. Amendment A11 is only accessible as a national standard. In Switzerland, for instance, it is known as SN EN ISO 13485/A11:2021 . All CENELEC member countries are required to publish the amendment without changes, meaning that all national publications, such as DIN in Germany, contain the same content. What is new SN EN ISO 13485 A11 2021? In detail, the CENELEC added European foreword and the informative appendix ZA and ZB. New European foreword New informative Annex ZA pointing to (EU) 2017/745 MDR Correspondence between this European standard and Article 10 Correspondence between this European standard and Annex IX New informative Annex ZB pointing to (EU) 2017/746 IVDR Correspondence between this European standard and Article 10 Correspondence between this European standard and Annex IX In standardization in general, one document after the other must be incorporated in order to have the correct final version. In this particular case, A11:2021 totally overwrites AC:2020. But keeps the text of ISO 13485:2016 as EN ISO 13485:2016 without any modification. What is SN EN ISO 13485/AC:2020? Is the corrigendum AC:2020 and ISO 13485:2016 point to the old regulations of MDD and IVDD. When your products are still certified under MDD and IVDD, then this corrigendum still is applicable. SN EN ISO 13485/AC:2020 Changes to European parts of EN ISO 13485:2016 This corrigendum changes the European foreword, and the informative European Appendixes ZA-ZC. In detail, this corrigendum incorporates the following corrections: Combination of EN ISO 13485:2016 and the corrigendum EN ISO 13485:2016/AC:2018. Which has superseded (replaced) EN ISO 13485:2012 and CEN ISO/TR 14969:2005. Changes to the informative Annex ZA. Where the correspondence to the amended 90/385/EEC on Active implantable medical devices   (AIMD)  is described. Changes to informative Annex ZB: Correspondence to the amended EU Directive 93/42/EEC on Medical devices (MDD) . Changes to informative Annex ZC: Correspondence to EU Directive 98/79/EEC on in vitro diagnostic medical devices   (IVDD) . SNV publishes the three publications separately. What is DIN EN ISO 13485:2021-12? Beuth has published a German consolidated version of EN ISO 13485:2016 + AC:2018 + A11:2021. The publication now carries the updated date of December 2021, which can occasionally lead to some confusion. However, having consolidated versions is beneficial for the industry, as it simplifies understanding the changes in regulations and the corresponding harmonized standards, which can be complex. What is the benefit of harmonised standards? By fulfilling the requirements of ISO 13485, you automatically comply with certain sections of the MDR and IVDR. Amendment A11:2021 highlights the common requirements between ISO 13485 and these regulations, making the interpretation of the standards clearer. Article 8 Use of harmonised standards 1.  Devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof. The first subparagraph shall also apply to system or process requirements to be fulfilled in accordance with this Regulation by economic operators or sponsors, including those relating to quality management systems, risk management, post-market surveillance systems, clinical investigations, clinical evaluation or post-market clinical follow-up (‘PMCF’). MDR and IVDR Article 8 (1) What are the topics for ISO 13485? ISO 13485 covers a wide range of topics essential for the quality management of medical devices. These include risk management, product lifecycle processes, regulatory compliance, documentation control, design and development procedures, manufacturing processes, and post-market surveillance. ISO 13485 also addresses supplier management, corrective and preventive actions, and internal audits to ensure continuous improvement and compliance with regulatory standards. The topics within ISO 13485 are all focused on maintaining high-quality standards throughout the production and delivery of medical devices. What is ISO 13485 in simple words? ISO 13485 is a globally recognized standard that defines the requirements for a quality management system specific to the medical device industry. In simple terms, it ensures that companies consistently design, develop, produce, and deliver medical devices that are safe and meet regulatory requirements. ISO 13485 focuses on risk management, product safety, and maintaining effective processes to achieve compliance with the legal standards of various markets. How to prepare for an ISO 13485 audit? Preparing for an ISO 13485 audit involves several steps to ensure compliance with the standard. First, review your organization's existing quality management system to ensure it aligns with ISO 13485 requirements. Ensure all documentation, including procedures, records, and training materials, is up to date and accurately reflects your processes. Conduct internal audits to identify any gaps or non-conformances and take corrective actions. Finally, train your staff to ensure they understand ISO 13485 requirements and are prepared to demonstrate compliance during the audit. The goal is to demonstrate that your quality management system complies with ISO 13485 standards for medical device production. ColabON's intelligence can automate parts of this task. What is required for ISO 13485? To meet the requirements of ISO 13485, a company must establish and maintain a quality management system specifically designed for the medical device industry. This includes having well-defined procedures for product design, manufacturing, risk management, regulatory compliance, and customer feedback. Documentation control, traceability of materials and processes, and consistent monitoring of quality through audits are also required. The organization must ensure that its quality management system meets the stringent requirements of ISO 13485 to guarantee the safety and efficacy of its medical devices. ColabON is a pioneer in data-driven compliance solutions. We support you with the interpretation of MDR, IVDR, and ISO 13485 by providing harmonized standards in a single, digital view. This gives you quicker access to the information you need, speeding up the implementation of MDR and IVDR requirements. Additionally, we seamlessly connect your QMS to regulatory demands, helping you identify gaps more efficiently and ensuring faster compliance #SNENISO13485 #MedicalDevices #Compliance #MDR #IVDR #QualityManagement #HarmonizedStandards #ISO13485 #RegulatoryAffairs #MedicalDeviceStandards #EuropeanCompliance #ColabON

The Importance of Effective Labeling Labeling is a critical aspect of medical device development and regulatory compliance. A clear, accurate, and comprehensive label is essential for: Patient Safety:  Ensuring correct usage and minimizing risks. Regulatory Compliance:  Adhering to national and international regulations. Product Identification:  Facilitating traceability and recall procedures. Brand Reputation:  Maintaining a positive brand image through consistent and professional labeling. Labeling for medical devices consists the following materials: Product labeling, product labels, product markings Labels, stickers, markings User manual, instructions for use, technical description Packaging Marketing materials Training material How to meet international labeling standards twice as fast? Access to over 1000 digital labeling requirements ( see medical device labeling data s et ) Streamlined labeling process Comprehensive catalog of standard labeling templates Why is medical device labeling (product labels, instructions for use, marketing materials) so crucial? Product Compliance: There are 1000 of labeling requirements in the regulatory requirements. Hence, labeling is a compliance risk. Patient safety:  Ensuring safe use by medical professionals and patients. Regulatory compliance:  Meeting regulatory requirements such as the Medical Devices Regulation (MDR). Product identification:  Unique identification of each product for traceability and quality assurance. Market access:  Facilitating access to international markets. In which standards and regulations are labeling requirements for medical devices and IVDs defined? Medical device labeling is subject to a complex web of international standards and regulations. Adherence to these guidelines is crucial for ensuring patient safety, regulatory compliance, and market access. EU Medical Devices Regulation (MDR):  The cornerstone of EU medical device regulation, the MDR provides comprehensive guidelines on labeling, including instructions for use. In Vitro Diagnostic Regulation (IVDR):  Tailored specifically for in vitro diagnostic devices, the IVDR outlines detailed labeling requirements, focusing on performance characteristics and result interpretation. ISO Standards:  A suite of international standards, including ISO 15223-1 (symbols), ISO 20417 (graphical symbols), and IEC 62366-1 (usability engineering), provide specific guidance on various labeling aspects. US FDA Regulations:  The FDA's 21 CFR Parts 801 and 820 outline US-specific labeling requirements and quality system regulations, respectively. MDSAP:  A harmonized regulatory process recognized by multiple countries, MDSAP incorporates labeling requirements based on underlying standards like the MDR and ISO 13485. Additional Labeling Elements: Unique Device Identifier (UDI):  A unique identifier for each device, enabling traceability throughout the supply chain. Instructions for Use (IFU):  Detailed instructions for safe and effective use of the device. Product Labeling:  Clear and concise information on the device, including its intended use, precautions, and manufacturer details What are the essential elements of medical device labeling? Medical device labeling is a critical component of ensuring patient safety and regulatory compliance. Here are the fundamental elements typically found on medical device labels: Product Identification:  A unique name or identifier that clearly distinguishes the device. Manufacturer Information:  The name and contact details of the manufacturer, establishing accountability. Intended Use:  A clear and concise statement of the device's purpose. Warnings and Precautions:  Prominent warnings and precautions to alert users of potential risks. Instructions for Use (IFU):  Detailed instructions on how to safely and effectively use the device. Lot Number and Expiration Date:  Information for traceability and ensuring product quality. Symbols:  Standardized symbols, such as the CE mark, provide quick, visual information. What are the challenges of medical device labeling? Creating comprehensive and compliant medical device labeling is fraught with challenges, including: Redundancies and Repetitions:  Many labeling requirements overlap, leading to inefficiencies. Language Barriers:  Labels must be translated into multiple languages to reach global markets. Technical Specifications:  Design constraints and readability standards can be complex. Time Constraints:  Developing and updating labels is a time-consuming process. With ColabON, you can meet international labeling requirements twice as fast. By centralizing labeling management, leveraging digital tools, and utilizing pre-built requirement catalogs, you can efficiently create compliant product labels. Save time and resources while focusing on your core competencies. Key benefits of our solution: Centralized Data Management:  All labeling data in one place. Digital Processes:  Streamlined label creation and management. Pre-built Templates:  Rapid development of new labels. Compliance Assurance:  Regular review and updates to meet regulatory changes. Expert Support:  Guidance from regulatory specialists. Conclusion Medical device labeling is a critical factor in ensuring product safety and success. By adopting a systematic and efficient approach to labeling, manufacturers can achieve regulatory compliance, reduce costs, and enhance patient safety. Want to learn more about optimizing your labeling process?  Contact us today! #medicaldevices #medicaldeviceindustry #regulatoryaffairs #qualityassurance #productlabeling #medicaldevicelabeling #compliance #MDR #IVDR #FDA #CEmarking #digitalhealth

Poor Data Quality lead to High time loss for experts in norm interpretation Very high costs for maintaining traceability High compliance risk 3 Problems of poor data quality and low degree of Digitization in Medical Device Industry In the world of regulatory compliance, the quality of your data can make or break your business. While many organizations focus on collecting and analyzing vast amounts of data, the real challenge lies in ensuring that the data is relevant, up-to-date, and complete. Digitization in Medical Device Industry is behind other industries. Poor data quality not only hinders employee efficiency but can also lead to serious compliance issues and derail project timelines. In this post, we’ll explore three critical data quality problems—irrelevant or incorrect data, outdated data, and incomplete data—and how they can impact your organization. We’ll also discuss how Colabon can help you mitigate these risks by providing high-quality, reliable data. Problem 1: Irrelevant or Incorrect Data Regulatory landscapes are complex, with thousands of ISO standards, laws, and guidelines available. However, not all of these are recognized or required by the relevant authorities. Using data based on irrelevant or incorrect standards can lead to significant non-compliance risks. For instance, if your organization follows an outdated ISO standard that is no longer accepted by regulators, your submissions could be rejected, leading to costly delays and potential penalties. Employees who work with irrelevant data often find themselves spending time aligning their work with inappropriate standards, only to realize later that their efforts were misdirected. This not only wastes valuable time but also results in a need for rework, reducing overall efficiency and delaying projects. Problem 2: Outdated Data Regulatory requirements are not static—they evolve over time. What was compliant last year might not meet today’s standards. Using outdated data can lead to severe compliance breaches, as regulations often require the most current information. For example, submitting an environmental impact report based on old data could result in non-compliance penalties. It’s crucial to continuously monitor and assess the current status of your regulatory data. Understanding how regulations have changed since the data was last evaluated is essential for maintaining compliance. Employees working with outdated data may unknowingly base their decisions on obsolete standards, leading to misaligned efforts and additional work. This can significantly delay project timelines as teams scramble to update their work to meet current regulations. Problem 3: Incomplete Data Incomplete data is another common issue that can have serious implications for regulatory compliance. This occurs when essential parts of a document, such as forewords, appendices, or even full sections of laws, are not made available to the experts. Selectively choosing only a few clauses or paragraphs from a legal document can lead to a skewed interpretation and an incomplete understanding of the requirements. When employees work with incomplete data, they risk making decisions based on an inaccurate or partial understanding of the regulations. This can result in errors that require costly and time-consuming revisions. Incomplete data can also severely impact project timelines, especially if the missing information is discovered late in the process, forcing teams to revisit and redo their work. Conclusion: In the high-stakes world of regulatory compliance, ensuring data quality is not just about accuracy; it’s about using the right, current, and complete data. Irrelevant or incorrect data, outdated data, and incomplete data can all lead to non-compliance, inefficiencies, and project delays. These risks can be mitigated by adopting robust data management practices that prioritize the quality and relevance of your data. Get in touch to improve your Data quality! At ColabON, we understand the critical importance of data quality in regulatory compliance. Our platform provides relevant, always current data that is aligned with the latest laws and standards. We continuously monitor and update our data to reflect any changes, ensuring that your organization remains compliant. Additionally, we provide complete datasets, including all essential documents and sections, so you have the full picture when making decisions. Don’t let poor data quality put your compliance at risk. Contact Colabon today to learn how we can help you maintain the highest standards of data quality and keep your projects on track. This blog post addresses the key issues related to data quality and positions Colabon as the solution provider. It’s designed to engage readers and encourage them to consider Colabon for their data quality needs. Let me know if there’s anything else you’d like to adjust! #DataQuality #RegulatoryCompliance #ComplianceRisk #DataManagement #ProjectManagement #BusinessEfficiency #ISOStandards #RegulatoryData #ComplianceSolutions #Colabon #RiskManagement #DigitalTransformation #BusinessIntelligence

Effectively Navigating Standards for Medical Devices in Europe and the USA Developing and marketing medical devices requires compliance with stringent standards and regulations to ensure product safety and quality for patients and users. This blog post explores the essential standards for medical devices in both Europe and the USA, offering practical tips to help your company navigate regulatory requirements and implement them effectively. European Regulations and Standards Medical Devices The two key regulations for medical devices in the European Union are: MDR (Medical Device Regulation) (EU 2017/745) : Applies to medical devices placed on the market in the EU. harmonisierten Normen zur MDR IVDR (In Vitro Diagnostic Medical Devices Regulation) (EU 2017/746) : Applies to in vitro diagnostics placed on the market in the EU. Die harmonisierten Normen zur IVDR Harmonized Standards in Europe for MDR and IVDR Europe has the concept of harmonized standards. Learn more about this concept here . Note: The international part of the standard (ISO and IEC) remains unchanged. Europe adds a foreword and a correlation to its regulations. Finding harmonized standards is simple as long as there are no changes to the regulations: Visit the European Commission's website. Select the regulation you wish to comply with. Look up the harmonized standards relevant to your type of service or product. What are the U.S. Standards and Regulations for Medical Devices? In the United States, the Code of Federal Regulations (CFR) is the closest equivalent to European regulations. The CFR includes various requirements relevant to the development, manufacturing, and distribution of medical devices in the U.S. CFR / Title 21 / Parts 11 – Electronic Records; Electronic Signatures 801 – Labeling 803 – Medical Device Reporting 820 – Quality System Regulation 830 – Unique Device Identification U.S. Standards and international standards medical devices Note: The international Part of ISO and IEC standards are the same. And there are many additional ANSI standards, especially for materials, that have no international equivalence, but that are also often used for european registration. Standards are also essential for american registration. The FDA recognizes certain standards as "Recognized Standards," which can help manufacturers meet FDA requirements more effectively. Guidelines issued by the Food and Drug Administration (FDA) play a significant role in U.S. approval processes. These guidelines provide recommendations for conducting clinical studies, preparing product information, and implementing quality management systems. Prominent Exemption in the U.S. is ISO 13485 As of 09.11.2024, the FDA still does not list ISO 13485 on their list of consensus standards. But, they gravitate towards it with the MDSAP single Audit Approach. What is MDSAP Single Audit Approach? The Medical Device Single Audit Program (MDSAP)  is an initiative designed to streamline the auditing process for medical device manufacturers by allowing a single regulatory audit to satisfy the requirements of multiple countries. This single audit approach minimizes the need for separate audits by regulatory bodies in each participating country, saving time and resources for manufacturers while ensuring regulatory compliance. The MDSAP currently includes five major regulatory authorities: United States (FDA) Canada (Health Canada) Australia (TGA) Japan (MHLW/PMDA) Brazil (ANVISA) The MDSAP single audit approach  enables medical device manufacturers to meet the regulatory requirements for these countries simultaneously, avoiding the need for separate audits. MDSAP correlates to ISO 13485 (old Version) all the quality system laws of the mentioned authorities above. How the MDSAP Single Audit Approach Works Under the MDSAP single audit approach, an authorized third-party auditing organization conducts a comprehensive audit of a manufacturer’s Quality Management System (QMS) following the MDSAP audit model. This standardized model ensures that the requirements of each participating regulatory authority are thoroughly reviewed and addressed in one audit. The MDSAP single audit  covers essential areas, including: Design and Development Processes Manufacturing and Process Controls Supplier Management Risk Management Corrective and Preventive Actions (CAPA) This approach ensures that each regulatory authority’s requirements are satisfied within a single, integrated audit process, enabling medical device manufacturers to maintain compliance across multiple regions effectively. Key Benefits of the MDSAP Single Audit Approach The MDSAP single audit approach provides several significant benefits: Reduced Audit Burden:  By consolidating regulatory audits into one MDSAP audit, manufacturers avoid duplicate audits, saving time and resources. Increased Market Access:  The MDSAP single audit approach grants easier access to major medical device markets, including the U.S., Canada, and Australia, opening up international opportunities. Enhanced Regulatory Confidence:  MDSAP audits are thorough and highly standardized, demonstrating to regulators and customers that manufacturers are committed to high-quality and regulatory standards. Improved Consistency in QMS:  By adopting the MDSAP single audit approach, manufacturers achieve greater consistency in their QMS practices across international markets, facilitating continuous improvement and alignment with global standards. Is the MDSAP Single Audit Approach Mandatory? The MDSAP single audit approach is mandatory for medical device manufacturers aiming to sell in Canada, where Health Canada has required MDSAP certification since 2019. In other regions, such as the United States and Australia, MDSAP audits are not mandatory but can replace routine audits, making it an attractive option for compliance with multiple regulatory authorities. Conclusion: Why the MDSAP Single Audit Approach is Advantageous For manufacturers looking to expand in global markets, the MDSAP single audit approach  offers a strategic, streamlined method for regulatory compliance. Through one comprehensive audit, manufacturers can meet the diverse requirements of multiple regulatory authorities, improve QMS practices, and gain access to key international markets. Adopting the MDSAP single audit approach allows medical device companies to focus on innovation while meeting the highest standards in regulatory compliance. This version maintains the focus on "MDSAP single audit approach" while providing a clear and informative overview. Let me know if you need further adjustments! How Colabon Can Help with Standards, Regulations and MDSAP Compliance? Navigating the requirements of the MDSAP single audit approach  requires precise coordination, thorough documentation, and up-to-date knowledge of each participating regulatory authority’s standards. Colabon provides a comprehensive solution that simplifies compliance management and keeps you aligned with MDSAP standards by offering: Centralized Documentation : Colabon allows you to store and organize all MDSAP-required documents in one accessible platform, ensuring easy access and streamlined updates when regulations change. Real-Time Regulatory Updates : With Colabon, stay informed of updates from all MDSAP-participating authorities, such as the FDA, Health Canada, and TGA, to ensure your QMS remains compliant. Impact Analysis Tools : Colabon’s impact analysis feature helps you quickly assess and respond to changes in regulatory requirements, minimizing disruptions and reducing time-to-compliance. Standardized Templates and Reports : Colabon provides templates aligned with MDSAP requirements, allowing you to efficiently document your processes, manage risk assessments, and generate audit-ready reports. Collaboration Across Teams : With Colabon’s collaborative tools, teams from quality management, regulatory affairs, and manufacturing can work together seamlessly to ensure all MDSAP criteria are met and maintained. By integrating Colabon into your compliance process, you can confidently manage your regulatory obligations, reduce the audit burden, and focus on innovation in medical device development. #MDSAP #MDSAPCompliance #MedicalDeviceStandards #RegulatoryCompliance #QualityManagementSystem #MedTechInnovation #FDA #HealthCanada #ANVISA #MedicalDeviceAudit #ISO13485 #Colabon #ImpactAnalysis

Standards and Regulations for Medical Devices: Not Obstacles, but the Key to Success, Innovation, and Trust Standards and regulations in medical technology are not obstacles; they are the foundation for success, innovation, and trust. With the right strategy and tools, you can master regulatory requirements and bring safe, innovative products to market faster. But how can you achieve this? Medical technology is heavily reliant on standards because of the vast variety of medical devices. Selecting the right standards from thousands requires strategy and experience. Over time, requirements start to overlap, and it becomes challenging to maintain an overview. LESS IS MORE – BUT TIMING IS OF THE ESSENCE! We provide the answers and share the 3 success factors for efficiently managing standards and regulations in medical devices and ivds. 1. Choosing the Right Standards and Regulations The first step to success: Select the standards and regulations that are truly relevant for your products. Leverage approvals from previous products or seek support from a notified body  or the FDA . Choose from the list of harmonized standards  and the list of consensus standards . Timing is crucial.  Define product requirements before starting development to avoid costly redesign loops. Standards act as a design input for products. Tip for Startups: Don’t waste weeks or months. Consult our experts—we’ll provide you with a curated and justified list of applicable standards. This is the single best investment you can make in compliance. 2. Reliable Information Through High-Quality Data An incorrect or incomplete data foundation can jeopardize your project. With the high-quality, always up-to-date data from ColabON , you can avoid delays and compliance risks. Automatic updates  whenever standards or regulations change. Data quality  that makes a difference. Faster approvals, earlier sales  enabled by up-to-date data and traceability. 3. Transparency and Trust Through Digital Solutions Transparency builds trust—both internally and externally. With ColabON's digital provision of standards and regulations, you can improve understanding across your entire team. Data visualization:  Your employees can grasp complex requirements more easily. Accessibility for the entire company:  A tool that connects and informs everyone. Traceable interpretations:  Linked data in ColabON ensures clear and consistent understanding. Achieve Success: Innovate with ColabON Standards and regulations in medical technology are opportunities, not obstacles. By using ColabON’s reliable data, expert guidance, and digital solutions, you can set a foundation for trust, compliance, and innovation. Ready to get started?  Contact us today and learn how ColabON can support you! #Medizintechnik #NormenRegularien #MDR #IVDR #Compliance #Innovation #ColabON #13485 #14971

Have your medical devices assessed for compliance and tackle the challenges of the EU-AI Act efficiently. We’re offering up to 3 manufacturers a unique opportunity to receive a complimentary compliance assessment of their medical devices  by students and supervised with Prof. Dr. Abächerli. This free assessment aims to guide you through the complexities of the EU-AI Act  with a smart, efficient approach—minimizing risks, managing regulatory demands, and helping secure the future viability of your innovations. Register here for the project presentation: 📅 Video Call on 18.11.2024, 16:00-17:00  with Prof. Dr. Abächerli Register for the project presentation: Video Call on 18.11.2024, 16:00-17:00 with Prof. Dr. Abächerli – either by emailing info@colabon.com  with the note "AI Project" or by filling out the contact form with the note "Videocall EU-AI Act and Medical Devices"; we will promptly send you the link to the videoconference. Benefits for You as a Participating Manufacturer Risk assessment for compliance  with the AI Act  for your medical devices Understanding the new requirements and compliance costs  arising from the AI Act Avoidance of an MDR-like scenario  through smart and efficient adaptation to the new regulations Take this opportunity to have 1-3 of your products analyzed by dedicated students under the supervision of Prof. Dr. Abächerli. Together, we will develop practical solutions to keep your MedTech products compliant and market-ready. Vision and Motivation #1 Applicability #2 Deadlies #3 Procedures and Deadlines #4 #5 Commitment and Collaboration Vision and Motivation #1: Why did Prof. Dr. Abächerli initiate this semester project? Prof. Dr. Roger Abächerli aims to support MedTech companies through strategic planning and early action to mitigate the impact of the EU-AI Act on medical devices . The goal is to help manufacturers ensure the regulatory compliance of their medical devices , as these can only be marketed in Switzerland and the EU under strict conditions. Specific cases and the resulting regulatory requirements need to be identified and implemented. A legal assessment of the EU-AI Act  is essential for medical device manufacturers  who want to market their products in Switzerland or the EU. To achieve this, specific use cases must be identified and the corresponding regulatory requirements under the AI Act  must be implemented. A thorough legal assessment of the EU-AI Act  is indispensable for medical device manufacturers  looking to distribute their products in Switzerland or the EU. Applicability #2: Why must medical device manufacturers address the regulation on artificial intelligence (EU-AI Act)? Automatic classification of medical devices as high-risk AI systems With the publication of the EU-AI Act  in June 2024 (Regulation (EU) 2024/1696), certain medical devices  will automatically be classified as high-risk AI systems. For manufacturers of these products, it is crucial to understand and implement the new regulatory requirements. Deadlines #3: By when must medical device manufacturers address the regulation on artificial intelligence (EU-AI Act)? On June 13, 2024, the EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION  published Regulation (EU) 2024/1689 on artificial intelligence (Artificial Intelligence Act). This regulation also applies to medical devices , with only a few exceptions in the classification. As of June 13, 2024, Paragraph (179) of the EU-AI Act states the following regarding deadlines: This Regulation should apply from 2 August 2026. However, taking into account the unacceptable risk associated with the use of AI in certain ways, the prohibitions as well as the general provisions of this Regulation should already apply from 2 February 2025. While the full effect of those prohibitions follows with the establishment of the governance and enforcement of this Regulation, anticipating the application of the prohibitions is important to take account of unacceptable risks and to have an effect on other procedures, such as in civil law. Moreover, the infrastructure related to the governance and the conformity assessment system should be operational before 2 August 2026, therefore the provisions on notified bodies and governance structure should apply from 2 August 2025. Given the rapid pace of technological advancements and adoption of general-purpose AI models, obligations for providers of general-purpose AI models should apply from 2 August 2025. #4: Procedure and Timeline Clarification of the AI Act’s Applicability to Your Medical Device Reviewing whether and how the AI Act  applies to your medical device  (qualification). Identification of Relevant Clauses Determining which specific clauses of the AI Act  are applicable to your medical device . Understanding the Impact Analyzing the applicable requirements of the AI Act  and their effects on your medical device  to ensure regulatory compliance. 1–3 manufacturers will be supported until the end of November 2024. The assessment will take place during the spring semester of 2025. #5: Commitment to Collaboration Provision of Relevant Information Manufacturers must provide the required data for their medical device  (subject to an NDA). Participation in Presentations Manufacturers are required to participate in interim and final presentations to monitor the progress of the assessment. ColabON: Your Central Platform for Regulatory Requirements in AI Act and Medical Devices and Artificial Intelligence (AI) A rapidly growing trend in the medical device industry  is the increasing use of software and artificial intelligence (AI). With the introduction of the EU-AI Act , many manufacturers face the challenge of understanding the new regulatory requirements and integrating them into their processes. Since this regulation is still very new and its legal interpretation remains unclear, it is crucial for manufacturers to have a solid foundation to plan the next steps. ColabON  offers a centralized regulatory database where regulations like the EU-AI Act  can be interpreted and commented on. This platform is continuously updated in light of the new regulation, which is expected to also apply in Switzerland. Manufacturers of medical devices  that wish to market their products in Switzerland or the EU must understand and implement the specific regulatory requirements of the EU-AI Act . A thorough legal assessment of the AI Act  is essential. ColabON  provides these assessments to all users of the platform, enabling the Swiss MedTech industry to benefit from an intelligent initial evaluation. Start-ups, in particular, which increasingly rely on AI  in their products and often lack the resources for comprehensive regulatory assessments in early development phases, can directly benefit from the published expert evaluations. ColabON  is a service provider specializing in quality management  and regulatory affairs  for the MedTech industry. In addition to MDR (Medical Device Regulation), ColabON  offers extensive support in applying the EU-AI Act . Students and experts collaborate to perform digital assessments and evaluations to ensure the compliance of medical devices . #EUAIAct #MedicalDevices #RegulatoryAffairs #MedTech #ArtificialIntelligence #AIinHealthcare #Compliance #QualityManagement #InnovationInMedTech #MedTechRegulation #AIRegulation #MedicalDeviceDevelopment #HealthcareAI

In the medical device industry, balancing compliance costs  with the need for speed and innovation is a constant challenge. How does your company handle this delicate balance while ensuring compliance with medical device regulations? A)  We have zero audit deviations we very slowly launch new products. B)  We experience some manageable audit deviations while still bringing medical devices to market. C)  What is an audit? Speed to market is our top priority. Registration is just another milestone. D)  Very little audit deviations, and we get medical devices to market fast. 💬 Where does your organization stand in terms of medical device compliance? Let’s discuss how you manage compliance and innovation together! If your answer is not D) get in touch! :-) #MedicalDeviceCompliance #ComplianceManagement #RegulatoryAffairs #MedTech #Audit #ProductDevelopment #Innovation #MarketAccess #RiskManagement #HealthcareCompliance.

In the highly regulated world of medical devices, staying compliant with ever-evolving regulatory requirements is critical for success. However, the increasing complexity of regulations, coupled with the challenges of managing vast amounts of data, can significantly hinder innovation and efficiency. This blog post will provide you with three essential tips to help you navigate these complexities and ensure your organization remains compliant, efficient, and competitive. 1. Prioritize Laws and Standards Over Guidelines: Reduced risk of non-compliance and fines. Focus on legally binding requirements for medical devices. Regulatory bodies enforce laws and standards more strictly than guidelines. 2. Invest in High-Quality Input Data and Digital Traceability: Increased efficiency, reduced errors, and improved decision-making. Data-driven approach to quality management. Regulatory requirements for data integrity and traceability. 3. Utilize a Tool for Impact Analysis: Effective risk management and resource allocation. Data-driven decision-making and proactive approach to change. Regulatory expectations for risk assessment and mitigation. Demonstrate forward-thinking and adaptability. ColabON manages regulatory requirements for medical devices Start using ColabON's Impact feature for regulatory requirements for medical devices By following these three tips and leveraging ColabON's powerful features, you can effectively manage the changing regulatory landscape for medical devices and ensure your organization remains compliant, efficient, and competitive. #medicaldevices #regulatorycompliance #dataquality #digitaltraceability #ColabON

The following Promt generated this image: is the image with the vision statement "From Regulation to Registration," using the Colabon color scheme. If you need any further modifications or adjustments, please let me know! It's beautiful, but maybe a bit overloaded.

Save the date! On June 26, 2024, an exciting event on the topic of AI + Regulation will take place at the Kaufmännisches Berufsbildungszentrum (KBZ) in Zug. In addition to academic representatives, Arlette Schilter, CEO of ColabON, will give a lecture on AI in Compliance Work. We would be delighted to welcome industry representatives to this event. Why should you participate? Learn about the latest developments in the field of AI and Regulation. Gain insights into the practical application of "AI in Compliance Work". Date: 26. Juni 2024 Time: 15:00 - 18:00 Uhr Anschließend Apéro Location: KBZ (Kaufmännisches Berufsbildungszentrum), Aabachstrasse 7 6301 Zug Further Informationen: Further details about the event will be provided shortly on the homepage von « Swiss Network for Digital Medical Regulation » (SNDMR). This event is organized in collaboration with the Business Development Division of the Canton of Zug. ColabON: ColabON: Your central hub for AI Regulation and harmonized AI standards With ColabON, you can access all relevant regulations, including those in the field of Artificial Intelligence (AI) – compactly and comprehensively prepared. Comprehensive Database: Our digital database includes all necessary regulations, including the planned harmonized norms for the Artificial Intelligence Act. Future-oriented: Furthermore, future harmonized norms and guidelines will be continuously integrated into our database. This ensures that you stay up-to-date with developments in AI regulation. #AIandRegulation