Porta Medica’s Post

🔍 𝗛𝗢𝗪 𝗧𝗢 𝗡𝗔𝗩𝗜𝗚𝗔𝗧𝗘 𝗧𝗛𝗘 𝗜𝗡𝗧𝗥𝗜𝗖𝗔𝗖𝗜𝗘𝗦 𝗢𝗙 𝗔𝗥𝗧𝗜𝗖𝗟𝗘 𝟱𝟮 𝗠𝗗𝗥? 📜 𝗧𝗛𝗜𝗦 𝗣𝗥𝗢𝗩𝗜𝗦𝗜𝗢𝗡 𝗜𝗦 𝗣𝗔𝗥𝗔𝗠𝗢𝗨𝗡𝗧 𝗙𝗢𝗥 𝗠𝗔𝗡𝗨𝗙𝗔𝗖𝗧𝗨𝗥𝗘𝗥𝗦 𝗔𝗜𝗠𝗜𝗡𝗚 𝗧𝗢 𝗕𝗥𝗜𝗡𝗚 𝗛𝗜𝗚𝗛-𝗤𝗨𝗔𝗟𝗜𝗧𝗬 𝗠𝗘𝗗𝗜𝗖𝗔𝗟 𝗗𝗘𝗩𝗜𝗖𝗘𝗦 𝗧𝗢 𝗠𝗔𝗥𝗞𝗘𝗧. 📃 Article 52 entails different assessment types depending on the risk class of your medical device, and orientation in those obligations might be difficult at first. 🔍 A manufacturer who is at the beginning of a conformity assessment may find the procedures described in Art. 52 MDR slightly confusing or complicated. Are you a manufacturer of risk class IIa devices? Then swipe to see a clearer graphical representation in the form of a diagram 📊 to illustrate the different conformity assessment pathways available to the manufacturer of risk class IIa. We hope that this diagram, intended for initial orientation, helps you with the beginning of your journey! 📘 𝗪𝗔𝗡𝗧 𝗧𝗢 𝗞𝗡𝗢𝗪 𝗠𝗢𝗥𝗘? 𝗗𝗢𝗡'𝗧 𝗛𝗘𝗦𝗜𝗧𝗔𝗧𝗘 𝗔𝗡𝗗 𝗕𝗨𝗬 𝗙𝗨𝗟𝗟 𝗔𝗖𝗖𝗘𝗦𝗦 𝗧𝗢 𝗢𝗨𝗥 "𝗣𝗥𝗔𝗖𝗧𝗜𝗖𝗔𝗟 𝗚𝗨𝗜𝗗𝗘 𝗧𝗢 𝗧𝗛𝗘 𝗘𝗨 𝗠𝗘𝗗𝗜𝗖𝗔𝗟 𝗗𝗘𝗩𝗜𝗖𝗘𝗦 𝗥𝗘𝗚𝗨𝗟𝗔𝗧𝗜𝗢𝗡" 𝗘-𝗕𝗢𝗢𝗞 𝗧𝗢𝗗𝗔𝗬.  https://lnkd.in/d_Cq4UB4 #medicaldevices #medicaldevice #biotech #FDA #medtech

📌 #IVDR NEWS- #Declaration_of_Conformity (#DoC) 📍 MedTech Europe published a template Manufacturer’s Declaration to facilitate the declaration of manufacturers with respect to Regulation (EU) 2024/1860. The template can be used also for: ✔ The extended transitional periods for devices for which the conformity assessment procedure pursuant to Directive 98/79/EC (#IVDD) did not require the involvement of a notified body and/or ✔ The validity of certificates issued under Directive 98/79/EC (IVDD) (Directive Certificate) and/or ✔ The compliance of the #Legacy_Devices and their manufacturer with the conditions for the continued placing on the market and putting into service. Any IVD #manufacturer may freely use this template to make their own declaration of the above. It may also be completed by the #authorised_representative on behalf of the manufacturer. The template consists of two parts: ☑ A text part with selectable portions of text as they apply and ☑ A schedule which lists the devices which the manufacturer intends to cover in its Declaration. Stay updated and prepared! Gsap Mado Otzri ☆ Dana Manaim - Tirosh Dalit Altmark

#Didyouknow The ISO - International Organization for Standardization Technical Committee 210 on ''#qualitymanagement 𝘢𝘯𝘥 𝘤𝘰𝘳𝘳𝘦𝘴𝘱𝘰𝘯𝘥𝘪𝘯𝘨 𝘨𝘦𝘯𝘦𝘳𝘢𝘭 𝘢𝘴𝘱𝘦𝘤𝘵𝘴 𝘧𝘰𝘳 𝘱𝘳𝘰𝘥𝘶𝘤𝘵𝘴 𝘸𝘪𝘵𝘩 𝘢 𝘩𝘦𝘢𝘭𝘵𝘩 𝘱𝘶𝘳𝘱𝘰𝘴𝘦 𝘪𝘯𝘤𝘭𝘶𝘥𝘪𝘯𝘨 #medicaldevices'' is surveying stakeholders who have used the #IMDRF’s guidance on Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices? (The guidance was published earlier this year and you can read it here: https://lnkd.in/e3-Kcbq5) The survey can be taken at AAMI’s website using the following link.  https://lnkd.in/eYt2hcGx It assesses: 👉Familiarity with Essential Principles and whether your organization uses the document. 👉Challenges associated with using the document. 👉Future resources you and your organization might find useful. The survey is aimed at individuals from #standards development organizations, #medtech industry, #academia, and #conformityassessment and #regulatorybodies. The results will inform future work of ISO/TC 210 to facilitate the best use of these essential principles. 𝐑𝐞𝐬𝐩𝐨𝐧𝐬𝐞𝐬 𝐰𝐢𝐥𝐥 𝐛𝐞 𝐜𝐨𝐥𝐥𝐞𝐜𝐭𝐞𝐝 𝐮𝐧𝐭𝐢𝐥 𝐀𝐮𝐠𝐮𝐬𝐭 9, 2024. #medtechnews #medicaltechnology #dispositivosmedicos #dispositifsmedicaux #dispositivimedici #medizinprodukte

🤝𝗔𝗡 𝗨𝗡𝗕𝗥𝗘𝗔𝗞𝗔𝗕𝗟𝗘 𝗩𝗢𝗪? 𝗜𝗦 𝗗𝗘𝗦𝗜𝗚𝗡𝗔𝗧𝗜𝗢𝗡 𝗢𝗙 𝗔𝗨𝗧𝗛𝗢𝗥𝗜𝗦𝗘𝗗 𝗥𝗘𝗣𝗥𝗘𝗦𝗘𝗡𝗧𝗔𝗧𝗜𝗩𝗘 𝗗𝗘𝗖𝗜𝗖𝗜𝗢𝗡 𝗠𝗔𝗗𝗘 𝗙𝗢𝗥𝗘𝗩𝗘𝗥?  The answer is NO—you can make changes! 🔄✨ 🔍 Change of the authorized representative is possible, and the specific requirements are set in Article 12 of MDR. The prescribed particulars are minimum requirements which may be extended by the parties concerned. ✅ The agreement must clearly indicate the timing of the termination of the outgoing authorized representative's mandate or the beginning of the mandate of the incoming authorized representative, as well as the date by which the outgoing authorized representative will be indicated in information supplied by the manufacturer, including any promotional material. 📅📈 🔒 In addition, it should include how the documents will be transferred and address the issue of confidentiality and related property rights. The agreement should also include an obligation for the outgoing authorized representative to forward to the manufacturer or the incoming authorized representative, after the end of the mandate, any complaints and reports from healthcare professionals, patients, or users about suspected incidents related to the medical device concerned by the mandate of the authorized representatives. Want to know more? Don't hesitate and buy full access to our "Practical Guide to the EU Medical Devices Regulation" e-book today. https://lnkd.in/d_Cq4UB4 #medicaldevices #medicaldevice #biotech #FDA #medtech

🚨The FDA urges medical device manufacturers to be vigilant in verifying third-party testing data before submitting it for approval.🚨 📢 The FDA's latest reminder underscores the critical need for device firms to scrutinize third-party-generated data rigorously. Fabricated or unreliable data jeopardizes marketing authorization, disrupts supply chains, and limits patient access to innovative solutions.🩺 💡To combat this, here are key steps for device firms:  1️⃣ Qualify third-party test labs diligently 2️⃣ Independently verify all testing results 3️⃣ Scrutinize data for inconsistencies or improbabilities 🤝 While partnering with accredited labs is encouraged, conducting independent assessments is essential. The FDA's Bioresearch Monitoring Program is actively addressing data integrity violations, but industry vigilance is crucial. 👀 👉 To access the full article, visit -  https://lnkd.in/ghwmrmRW #FDA #medicaldevices #patientsafety #dataintegrity #healthcarequality

Great direction and insight from Justin Bushko Concise Engineering, Inc. Do you have the resources to do the project twice because your trying to “save money”? Without strong traceability risk goes up and it takes longer to identify where an issue originates which means more resources spent on investigation and overall remediation. Whether it’s hiring Top Talent, picking the right partner or consultants, buying an electronic QMS, purchasing supplies or components, and establishing your Design History File if you approach it transactionally, you will get transactional and potentially painful results. #riskmanagement #efficiency #qualitymatters #leadershipmatters #proactivity #intentionality #regulatorycompliance #designquality

🎥 New Video: Navigating Regulatory Hurdles 🎥 In our latest video, Justin Bushko from Concise Engineering shares key insights into navigating regulatory hurdles in the medical device industry. Compliance is critical for success, and it starts with understanding the regulatory landscape—both local and international. 📄 Key Takeaways: Thorough documentation and traceability are essential. Stay updated on evolving regulations through newsletters, workshops, and expert consultations. Regular audits help maintain compliance and prevent costly delays. Our consultants collaborate with regulatory experts to streamline the process, ensuring you bring your product to market with confidence. Watch the full video and let's discuss how we can help you overcome your regulatory challenges. 🖊️Subscribe to our channel https://lnkd.in/eHWBKWev #fda #regulation #video #medtech #medtechman #medicaldevices #technews

IS DRAFTING A DECLARATION OF CONFORMITY A ONE-TIME TASK❓ 📝 Article 19 of the MDR holds the key to the answer! 🔍   📜 The declaration of conformity is the most important document for users of devices, but also for the individual operators involved in the distribution chain to verify that the requirements of the MDR have been met for the device. The manufacturer is required to keep the declaration of conformity up to date. For example, if a manufacturer starts using additional common specifications, they need to update their declaration of conformity. This means issuing a new EU declaration of conformity as soon as the first product affected by these changes is placed on the market. The mandatory elements of the EU declaration of conformity are set out in Annex IV MDR. The Annex IV sets out its minimum scope. It is therefore possible to include additional information on the declaration of conformity. The list of mandatory elements was absent in the previous legislation. Member States may determine in which language the EU declaration of conformity must be presented for placing or making devices available on their market.   Want to know more? Don't hesitate and buy full access to our "Practical Guide to the EU Medical Devices Regulation" e-book today. https://lnkd.in/d_Cq4UB4   #medicaldevices #medicaldevice #biotech #FDA #medtech  

#Didyouknow The FDA has updated its Recognized Consensus Standards database to include new standards and new versions of recognized standards, as well as a revision to one standard’s extent of recognition? Read more: https://lnkd.in/ghwwnsdf 📌Two new Technical Information Reports (TIRs) related to #medicaldevice #sterilization: 👉AAMI TIR12:2020 (R2023) – Designing, Testing, And #Labeling Medical Devices Intended for Processing By Health Care Facilities: A Guide for Device Manufacturers. This TIR provides direction to manufacturers to develop instructions for processing steps to accompany reusable and single-use medical devices processed by #healthcare facilities prior to #clinicaluse. 👉AAMI TIR28:2016/(R)2020 – Product Adoption and Process Equivalence for #EthyleneOxide. This TIR provides assistance to manufacturers and sterilizers when adding new or modified products to an existing validated EO sterilization process. It also augments the FDA-recognized ANSI/AAMI/ISO 11135 standard. #medtech #medicaldevices #fdacompliance #standards

What do you know about Recognized Consensus Standards? A discussion on this topic took place during the Medical Device Sterilization Town Hall facilitated by the FDA on March 21st. As one would imagine, using consensus standards in a Premarket Review holds significant value. Why, you ask? 🎸 It refines Additional Information questions 🎸 FDA-endorsed standards fuel support in device claims 🎸 Conformity assessment resources are collaboratively shared across jurisdictions 🎸 Declaring conformance with recognized standards typically trims down submission documentation 🎸 It provides more transparent regulatory expectations, such as standardized testing methods (for example, ISO 11135:2014 for Ethylene Oxide cycle validation) There's an entity named The Division of Standards and Conformity Assessment (DSCA). They back the FDA's mission by propelling the development, recognition, and suitable use of voluntary consensus standards for medical devices, radiation-emitting products, and burgeoning technologies. So, 'Recognition' refers to the FDA's formal identification of a standard after analysis determines it is suitable for manufacturers to affirm conformance (through a declaration of conformity) to meet relevant requirements. You may already know that recently the FDA partially recognized ISO 10993-17 and fully recognized ISO 22441. Wondering how to verify this? Visit the website https://lnkd.in/e5rjGGP Next, in the 𝘚𝘵𝘢𝘯𝘥𝘢𝘳𝘥 𝘋𝘦𝘴𝘪𝘨𝘯𝘢𝘵𝘪𝘰𝘯 𝘕𝘶𝘮𝘣𝘦𝘳 field, input the standard number you are interested in and hit enter! Simple and straightforward, right? 😉 Lastly, let's not forget the collective power we hold in advancing standards! ↪ The FDA emphasizes that we can drive progress by: 📍Exploring new methods for sterilization 📍Suggesting new standards you believe might be beneficial 📍Engaging in the standards development process to foster the adoption of additional sterilization procedures 📍Proposing sterilization standards for recognition Interested to know more? Follow us! #medicaldevice #medtech #biocompatibility #biologicalsafety #ISO10993 #sterilization #ETO #standards #premarketreview #regulatory