NAMSA’s Post

📐 GRC Infographic  🩺🌡💉 Medical devices 📘 EU Regulation MDR 745/2017 – Annex III and ISO 13485 standard 📘 The EU MDR Regulation 745/2017 recalls Annex III technical documentation on post-market surveillance (PSM). 📝Annex III defines the contents of the post-marketing surveillance plan for the medical device.   📝In particular, Annex III recalls the following contents of the PSM: ✅ 1.Process to collect all information; ✅ 2.process to evaluate the data collected; ✅ 3. Indicators and threshold values for cost-benefit analyses; ✅ 4. Methods for managing complaints and market returns; ✅ 5. Methods for investigating trends; ✅ 6. Methods for communicating with the competent authorities; ✅ 7. Procedures to manage the Manufacturer's obligations; ✅ 8. Procedures for managing corrective actions; ✅ 9. Procedures to identify medical devices subject to corrective actions; ✅ 10. Post Clinical Market Follow Up Plan (PCMF). 📘 Annex III correlates to clause «8.2 Monitoring and measurement» of the UNI CEI EN ISO 13485:2016 standard «Medical devices - Quality management systems - Requirements for regulatory purposes». #medicaldevices #dispositivimedici #MDR745 #cermarking #marcaturace #documentazionetecnica #technicaldocumentation #PSM #quality #ISO13485 #PSM #PMCF 

#MDCG 2022-11 has been updated to Revision 1, with the addition of a section "Call to notified bodies to streamline the certification process" and a revision to the section "Call to manufacturers to transition to the Regulations and submit their applications for certification without further delay". This follows concern surrounding the continued availability of medical devices in the EU as the revised deadlines for compliance to the MDR and IVDR approach. While notified bodies have increased their capacity, June 2023 data indicates that both applications and subsequent certifications are low, especially for IVDs. The guidance also includes data comparing the numbers of QMS and product applications with certifications, showing a significant contrast in these figures. For example, while 9,071 QMS applications were received by June 2023, only 2,682 certificates had been issued by that time. Similarly, 4,106 MDR device applications had been submitted, with just 1,217 certificates issued. If you require support on your #MDR or #IVDR journey, our team are here for you. Our team of industry experts have a wealth of experience in all aspects of CE marking, from technical file preparation, responding to notified body queries, QMS certification and regulatory strategies. Book your free consultation now at https://lnkd.in/eHTS7FyM

It’s good to know the basics! Do you know the basic requirements for medical device reporting (MDR) (21 CFR Part 803)? Here is a quick run-down for manufacturers.   Basic requirements of MDR for manufacturers are: ✅ Submit reports of MDR reportable events (21 CFR 803.10(c) and 803.50) ✅ Develop maintain, and implement written procedures for the identification and evaluation of all medical device events (e.g., malfunctions, serious injuries, and deaths) to determine whether the event is an MDR reportable event (21 CFR 803.17) ✅ Establish and maintain complete files for all complaints concerning medical device events (21 CFR 803.18)   To submit an MDR reportable event, use an electronic equivalent Form 3500A approved by FDA. Information requirements are: ✅ Information that you can obtain by contacting a user facility, importer, or other initial reporter. ✅ Information in your possession. ✅ Information obtained by analysis, testing, or other evaluation of the device.   To learn more, visit https://lnkd.in/eHakrxKH If you need help navigating these regulations, we can help! Contact us at FindExperts@hicatalysts.com.   Stay tuned next week for our post on the requirements on the 3 types of MDR reports. Keep informed for compliance excellence! #LDT #MDR #FDA #Healthcare #Regulations #Manufacturers

🤗 Here are the medical device reporting (MDR) basic requirements for those who need to know! Healthcare Innovation Catalysts #HICexplains #HIC #FDA #MDR #MedicalDevices

📐 GRC Infographic  🩺🌡💉 Medical devices 📘 EU Regulation MDR 745/2017 – Annex III and ISO 13485 standard 📘 The EU MDR Regulation 745/2017 recalls Annex III technical documentation on post-market surveillance (PSM). 📝Annex III defines the contents of the post-marketing surveillance plan for the medical device.   📝In particular, Annex III recalls the following contents of the PSM: ✅ 1.Process to collect all information; ✅ 2.process to evaluate the data collected; ✅ 3. Indicators and threshold values for cost-benefit analyses; ✅ 4. Methods for managing complaints and market returns; ✅ 5. Methods for investigating trends; ✅ 6. Methods for communicating with the competent authorities; ✅ 7. Procedures to manage the Manufacturer's obligations; ✅ 8. Procedures for managing corrective actions; ✅ 9. Procedures to identify medical devices subject to corrective actions; ✅ 10. Post Clinical Market Follow Up Plan (PCMF). 📘 Annex III correlates to clause «8.2 Monitoring and measurement» of the UNI CEI EN ISO 13485:2016 standard «Medical devices - Quality management systems - Requirements for regulatory purposes». #medicaldevices #dispositivimedici #MDR745 #cermarking #marcaturace #documentazionetecnica #technicaldocumentation #PSM #quality #ISO13485 #PSM #PMCF 

📢 MDCG 2022-4 “Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD” has been revised to align with Regulation (EU) 2023/607. 📄 The guidance document now includes all the updated transitional timelines and provisions for legacy devices using Article 120 to remain on the market whilst they conclude their MDR conformity assessments. 🔍 If you are finding the requirements and structure of Article 120 to be confusing, then MDCG 2022-4 will provide some level of clarity. 👉For more information on how this guidance impacts your medical devices, visit our website at specculo.com or contact us at info@specculo.com. #MedicalDevices #MDR #MDD #AIMDD #EURegulations #HealthcareCompliance #RegulatoryAffairs #MedicalDeviceRegulation #TransitionalProvisions #MDCGGuidance #Healthcare #MedTech #QualityAssurance #RegulatoryGuidance #EUHealthcare #ConformityAssessment #LegacyDevices

Why aren’t DMR, DHR and DHF named in FDA's Final Rule on the new Quality Management System Regulation (QMSR)? That's because QMSR is incorporating ISO 13485:2016 by reference, and ISO 13485:2016 doesn’t use these three terms. Instead, it uses the term Medical Device File (MDF) to refer to all the records that are traditionally split up amongst the DMR, DHR, and DHF. In this article, we explain FDA’s decision and elaborate on what this means for medical device manufacturers going forward. Read more here: https://bit.ly/3yWAOEL #qmsr #qualitymanagement #qualitymanagementsystem #fda #medicaldevices #medtech #greenlightguru

📅 Is your medical device company ready for 26 May 2024? A reminder of your obligations: 26 May 2024 - Manufacturers must have a quality management system (QMS) compliant to Article 10(9) of the MDR and initiate a formal application with a Notified Body for MDR Conformity Assessment. 26 September 2024 A formal agreement with a Notified Body must be signed, ensuring appropriate surveillance for legacy devices. #mdr

📣 MDCG 2022-11 Revised, Nov 2023 Notice to Manufacturers and Notified Bodies to ensure timely compliance with MDR and IVDR requirements. 🔶NEW: 🔹Call to Notified Bodies to streamline process 🔹IVDR in scope 🔶REVISION: 🔹Inclusion of latest Notified Body Data. 🔹Call to manufacturers to transition to the regulations and not to further delay applications for certification. 🔹Warning that certification applications are taking more time compared to directives. For MDCG, see document in link: https://lnkd.in/d6HRgv9b For any support with #mdr #ivdr transitions and applications, get in touch for an informal chat on how we may be able to help. J-Reg Consultancy Ltd have worked with a number of manufacturers to support successful transition to the regulations. #mdr #ivdr #notifiedbody #mdcg

The journey doesn't end once your product hits the market. Under the EU MDR, post-market surveillance (PMS) and post-market clinical follow-up (PMCF) are a critical part of ensuring the continued safety and effectiveness of your device. Our whitepaper offers valuable tips for conducting an effective PMCF study. Ensure the ongoing success of your medical devices in the market. Download the whitepaper now. https://bit.ly/3iU1MT9 #SterlingMedical #MedTech #MedicalDevice #EngineeringServices #RegulatoryServices #CE #MDR #EU #PostMarket #Compliance #PMS #PMCF