Arnab Sarkar

📢 Dear Manufacturer and Regulatory Affairs, 🔎 Today’s subject: 2017/745 EU MDR Annex XVI devices 📍 According to the 93/42 EEC MDD, your product may be determined as a medical device but 93/42 MDD has no specific rules or routes like MDR. 1️⃣ Firstly, please check Annex XVI. 👉 According to 2017/745 EU MDR, your product dossier may be prepared according to Annex XVI and their Common Specifications 💡 What does Annex XVI mean? ⚠ LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2) 1. Contact lenses or other items intended to be introduced into or onto the eye. 2. Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings. 3. Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing. 4. Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty. 5. High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment. 6. Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain. ➡️ If your product is suitable for one of them, 🎯 You must follow MDCG 2023-5 Guidance on qualification and classification of Annex XVI products - A guide for manufacturers and notified bodies. This document gives you information about a group of your product and classification. The title ”3 Qualification” has very important information about product like 3.2 Accessories, 3.3 Dual-purpose devices and 3.4 Multiple intended purposes. 🎯 For Common Specifications, EU 2022/2346 and EU 2022/2347 must be followed. These documents give you GSPR requirements, risk analysis, IFU and label requirements. 🚨 Please take care of Annex XVI, it will affect many manufacturers and products. 🖱️ For CS, (EU) 2022/2346: https://lnkd.in/dd4u7bvN (EU) 2022/2347: https://lnkd.in/dENCYiaS Best wishes. #medicaldevice #medicaldevices #ANNEXXVI #MDR

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🔬 Just when we thought #IVDs were feeling left out of the #EU #vigilance conversation, #MDCG 2023-3 Rev. 1 brings them right to the spotlight! The title of the guidance now reads "Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746" - Enough said! #regulatoryupdate #invitrodiagnostics #medicaldevices #eumdr #euivdr #europeancommission

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😵‍💫 FDA (510k,PMA, de Novo) versus EU MDR notable differences or not the same. Here is our list of FAQ to help you explore the differences between the jurisdictions and conformity routes. #MedTechclearance #Medtech #FDA

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So excited for this webinar; my boss is leading it, too!✨ Be sure to sign up to learn more about our “day-to-day” as Regulatory Professionals in the world of Total Artificial Hearts (TAHs)! 🫀⚙️ #regulatoryaffairs #totalartificialhearts #hearthackathon

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Team NB MDR Certification Process. Disappointingly in my view lacking any provision for remote working companies without full time presence at premises eg explanation of hybrid audits and unannounced audits; the order of things (e.g. one NB does QMS then MDF whereas another does MDF then QMS); or any target timelines. Guidance on what to expect in NB terms of service e.g. reporting adverse events and significant changes would be good, as NBs put those in their QMS audit criteria along with MDR & IVDR (and 13485). Finally from me a reminder to put the Notified Body on the Approved Supplier List, per the QMS, and monitor their performance - give the NB feedback like any other supplier.

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MDCG 2024-7 Rev.01 and MDCG 2024-7 Annex to Application Form & Preliminary assessment review (PAR) Template MDR (List of documents) Let's Connect to Exchange Medical Device Regulatory Insight 👉🏻 Prashil Gondane #EU #MDCG #Medicaldevice #MD #GlobalRegilatoryAffairs #Regulatoryaffairs #MedTech

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🎉 I'm happy to share that I obtained the RCC-MDR certification from Regulatory Affairs Professionals Society (RAPS). The #MDR holds a special place in my heart and has been a major focus of my regulatory career over the last 5 years. 💡 RCC Facts: The Regulatory Compliance Certification (RCC) is a leading credential for #regulatory professionals in the #healthcare product sector. It is intended for individuals employed in regulatory agencies, industry, consultancies and other settings involved with the regulation of healthcare products. Success on the RCC exam requires knowledge of: ✅ Conformity of the Devices 📃 Technical Documentation 🔎 Post-marketing Surveillance ⚖ Vigilance 🔬 Clinical Investigations 

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Current challenges with validations in the medical device industry: Regulatory Compliance: Keeping up with stringent and evolving global regulations (e.g., FDA, EU MDR) that require comprehensive validation processes for devices, including software and hardware. Data Integrity: Ensuring the accuracy, consistency, and completeness of data during validation processes, especially in automated systems, remains a critical issue. Documentation Burden: The need for extensive documentation and traceability throughout the product lifecycle adds complexity and time to the validation process. Technology Advancements: Rapid innovation in medical devices, such as incorporating AI, requires new validation approaches, making existing protocols potentially outdated. Resource Constraints: Lack of skilled personnel or adequate tools to conduct rigorous validation processes efficiently can delay product launches and increase costs. To come out of it Stay Updated on Regulations: Regularly monitor global regulatory changes and ensure alignment by incorporating a robust quality management system (QMS) that includes updated guidelines. Enhance Data Management: Use advanced data management tools and automated systems to ensure data integrity, improve accuracy, and streamline the validation process. Streamline Documentation: Adopt digital documentation solutions to reduce the manual burden, ensuring real-time updates and easier compliance tracking. Leverage Expertise and Training: Invest in continuous training for your team on evolving technologies and validation methodologies, especially for emerging technologies like AI. Outsource or Automate: Consider outsourcing complex validation tasks to specialized service providers or implementing validation automation tools to address resource limitations and speed up the process.

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🔍 Ensuring Safety and Compliance in Medical Device Production and Post-Production: Adhering to ISO 14971 🔍 Adherence to ISO 14971 is crucial for managing risks throughout the product lifecycle, from production to post-production. Production: During the production phase, ISO 14971 emphasizes risk management to ensure that each device meets safety and performance standards. This includes: Implementing rigorous quality control processes. Regularly monitoring and testing products to detect potential issues early. Ensuring all manufacturing activities comply with regulatory requirements and industry standards. Post-Production: The post-production phase involves continuous monitoring of the device once it is on the market. According to ISO 14971, this includes: Collecting and analyzing data from device performance in the field. Conducting post-market surveillance to identify and mitigate risks. Updating risk management files with new information and implementing corrective actions when necessary. By adhering to ISO 14971, medical device companies can ensure that risks are systematically identified, evaluated, and mitigated throughout the product lifecycle. This proactive approach not only enhances patient safety but also strengthens regulatory compliance and market confidence. #MedicalDevices #ISO14971 #RiskManagement #Production #PostProduction #QualityAssurance #PatientSafety #RegulatoryCompliance

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Brazilian GMP certificate validity extended to 4 yrs On April 1, 2024, the new ANVISA regulation RDC 850 (2024) has entered into force extending the validity of Brazilian GMP certificates (also called CBPF) from 2 yrs to 4 yrs. However, this is applicable only for manufacturers holding an MDSAP certificate. Based on my experience, ANVISA already started issuing B-GMP certificates with 4 yrs validity, even if the application was submitted in Q4 2023. Link to the regulation (in Portuguese): https://lnkd.in/edaYezZm With this ANVISA delivers on their regulatory agenda for 2024/25 (see also details in one of my previous posts: https://lnkd.in/eYRkF6qc) #anvisa #medicaldevice #regulatoryaffairs #medtech #mdsap #bgmp #cbpf #rdc850

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★ Increase in QMS Risk Management Requirements under the QMSR ★ Medical device companies that need to transition to the QMSR and do not currently follow ISO 13485:2016 could have many gaps in their QMS. One significant difference between the current QSR and the requirements under the QMSR is in risk management, which is mentioned throughout ISO 13485:2016. With the QMSR the FDA is shifting to a more integrated risk management approach. It requires medical device companies to consider risk not just as a one-time analysis activity as in the QSR, where risk is only considered once in the design validation requirements, but now the risk management process will be integrated into every aspect of the medical device lifecycle. We offer a QMSR Gap Analysis Checklist to identify all QMS gaps, including for risk management. Link:  https://lnkd.in/gSbjhEnN To better understand the QMSR, we have added a QMSR Transition to ISO 13485:2016 slide deck + 3 QMSR Guidance Manuals plus Transition Planning Form Templates. On downloading the checklist you will receive these free documents by email. #iso13485 #qualitymanagement  #qualityconsulting #riskmanagement

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📌 What’s New? As part of the FY 2023 Omnibus Act, the FDA updated its guidance to include the 506J Device List, identifying devices subject to these reporting requirements. The FDA also encourages voluntary notifications to help prevent shortages. But What is 506J? Section 506J of the FD&C Act empowers the FDA to address potential medical device shortages during or ahead of public health emergencies. It requires manufacturers of certain devices to notify the FDA about production disruptions that could impact supply. 💡 Takeaway: If your device is on the 506J Device List, you must notify the FDA about any production issues. Stay informed and check the list to ensure compliance. For more details, see the updated 506J guidance!

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#QMSR will be part of the topics that we will discuss in the upcoming course. Want to know more? Talk to me 🤗

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🔍 EU MDR Economic Operators! 💼 In the intricate world of medical device regulation, Economic Operators play a pivotal role in ensuring compliance and safety. Let's delve into their roles: 1. Manufacturer: These visionaries design, produce, and label medical devices according to EU MDR standards, ensuring safety and quality throughout the device lifecycle. 2. Authorized Representative (AR): Serving as a bridge between non-EU manufacturers and European authorities, ARs ensure compliance with regulations and facilitate communication in case of inquiries or incidents. 3. Importer: Importers bring devices from outside the EU into the European market, verifying compliance with EU MDR requirements and fulfilling obligations in product registration and documentation. 4. Distributor: Responsible for placing devices on the EU market, distributors ensure compliance with EU MDR standards, proper labeling, and packaging, ensuring safe delivery to end-users. Understanding these roles is vital for upholding regulatory standards and ensuring patient safety. Let's navigate this landscape together! 💡 #EU_MDR #MedicalDevices #Compliance #RegulatoryStandards #medical

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USFDA: 510 (K) vs PMA Simple Understating In the U.S., medical devices must go through the FDA's regulatory pathways before they can be marketed. The two primary pathways are 510(k) and PMA (Pre-Market Approval). These differ significantly in terms of requirements, time, and the risk level of the devices they apply to. 510(k) (Premarket Notification) Purpose: Used to demonstrate that a new device is substantially equivalent to a device that is already legally marketed in the U.S. (called a "predicate device"). Device Classification: Typically applies to Class I and Class II medical devices, which are considered low to moderate risk. Review Process: The manufacturer submits a premarket notification to the FDA. The manufacturer must demonstrate that the device is at least as safe and effective as a legally marketed predicate device. No clinical trials are generally required unless there are significant technological differences. Timeline: Typically shorter, with an average review time of 3-6 months. Cost: Less expensive, with fees significantly lower than PMA. Examples: Surgical gloves, blood pressure cuffs, and some diagnostic devices. PMA (Premarket Approval) Purpose: This is the most stringent FDA review process and is required when there is no predicate device, or for devices that are high risk. Device Classification: This applies to Class III medical devices, which are considered high-risk and typically support or sustain life, or present a potential unreasonable risk of illness or injury. Review Process: The manufacturer must provide clinical data to prove that the device is safe and effective for its intended use. This typically involves extensive preclinical and clinical trials. The FDA conducts a more rigorous scientific and regulatory review compared to 510(k). Timeline: Longer, with reviews often taking 6-12 months or more. Cost: More expensive due to the extensive testing and regulatory documentation required. Examples: Heart valves, pacemakers, and implantable devices. Key Differences: Risk Level: 510(k) for lower-risk devices; PMA for high-risk devices. Data Requirements: 510(k) requires substantial equivalence, while PMA requires proof of safety and efficacy through clinical data. Time and Cost: PMA is generally much more time-consuming and costly than 510(k).

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What is Substantial Equivalence as per #usfda A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is as safe and effective as the predicate. A device is substantially equivalent if, in comparison to a predicate it: 1.     has the same intended use as the predicate; and 2.     has the same technological characteristics as the predicate; or 3.     has the same intended use as the predicate; and 4.     has different technological characteristics and does not raise different questions of safety and effectiveness; and 5.     the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device. Reference: https://lnkd.in/gmjCfHX8 #usfda #510k #medicaldevice

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Joinn our WhatsApp Channel for daily regulatory updates important to your daily updates, whetehr they are updates in #regulation #recall #notices etc are directly on your whatsapp. https://lnkd.in/dbANPe-y #regulatory #insights #updates #cdsco #google #usfda #manufacturers #medicaldevices #ivd

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🔎 Internal QMS Audits under the QMSR 🔍   Medical device companies that need to transition to the QMSR and are not currently following ISO 13485 could have significant gaps in their QMS. Requirements for internal auditing are substantially similar, with some additional requirements under ISO 13485 A comprehensive QMSR Gap Analysis Checklist is available for download to identify potential QMS gaps.  https://lnkd.in/gSbjhEnN Includes transition support documents to help understand potential gaps and changes to meet the QMSR. After downloading the QMSR Checklist, you will receive these documents by email: 📗 QMSR Introduction & ISO 13485:2016 Requirements, 📗 QMSR Transition Guidance Manuals 📗 QMSR Transition Planning Form Templates Link to Blog: Best Practices for Internal Audits: https://lnkd.in/g3SFxuTR #iso13485 #qualitymanagement  #qualityconsulting #qmsinternalaudits

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