Kiwa Medical

They ?????????????????? ?????? ???????????????? ???????? ?????? ?????????????????????????? ?????????????????????? ?????? ?????????????????? ???????? ???????????????????? ?????????????? ?????????????????????????? ?????? ???????????????? ????????????. ???????? ?????????????? ???????????????? ????????????' ?????????????????? ???????? ???????????????????????????? ???? ?????? ???????????? ??????????????.

10???? ???????????????? ???????????? ???????????? ???? ???????????????????????????? ?????? ???????????????????????? (??????/????????) ???????????? This document presents the results of the 10th Notified Bodies (NB) survey on certifications and applications under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) as of June 30, 2024.? ?? ?????? ???????????? ??????????????:? 1. ???????????? ????????????????: The survey was conducted from July 1 to August 6, 2024, with a 100% response rate from 50 notified bodies (NBs) designated under MDR and/or IVDR.? ? 2. ?????? ????????:?? ???????????????????????? ?????? ????????????????????????: 26.185 MDR applications and 8.905 MDR certificates issued.? ????????????????????: Majority of QMS certificates are issued within 6-12 months, while QMS+Product certificates take 13-18 months.? ?????????????? ?????? ??????????????: Main reasons include "outside the scope of NB’s designation" and "application not complete."? ? 3. ???????????????????? ????????????????:?? Completeness of Submissions: Many submissions are incomplete, requiring additional information.? ???????????????????? ???? ?????????? ????????: More time is spent with the manufacturer than with the notified body during the certification process.? ? 4. ?????????????? ?????? ??????????????:? The main reasons for application refusals were "outside the scope of NB’s designation" (55%) and "application not complete" (16%).? ? 5. ???????????????? ???????????????????? ????????????????????:? Applications requiring consultation procedures for devices incorporating medicinal substances or tissues/cells were noted, with a small number of certificates issued for these categories. 6. ?????????????? 117 ?????? ????????????????:? 442 requests for initial market authorization submissions and 19 for changes were received, with 298 and 10 opinions issued, respectively.? These findings underscore both the progress made and the challenges encountered in the certification processes under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).? They ?????????????????? ?????? ???????????????? ???????? ?????? ?????????????????????????? ?????????????????????? ?????? ?????????????????? ???????? ???????????????????? ?????????????? ?????????????????????????? ?????? ???????????????? ????????????. ???????? ?????????????? ???????????????? ????????????' ?????????????????? ???????? ???????????????????????????? ???? ?????? ???????????? ??????????????. The survey, conducted by the Austrian National Public Health Institute and Areté Civic Consulting, aims to monitor the availability of medical devices in the EU market. ???????? ?????? ???????? ???????????????? ????????: https://lnkd.in/e3Hm85mb #KiwaMedical #MDR #MedicalDeviceRegulation #NotifiedBodiesSurvey #CertificationsAndApplications

?????? ???????????? ?????? ?????????????????????????? ?????????? ???? 2024/1860 ???????????????????? ???? ???????????????????? (????) 2017/745 ?????????????? 10(??) On October 30, the EU Directorate General for Health and Food Safety published a news item titled “??&?? ???????????????????? ???? ???????????? ???? ???????? ???? ???????????????????????? ???? ?????????????????????????????? ???? ????????????”. This news item has the details of EU 2024/1860, which was published in June and amends EU 2017/745.??(* EU 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a?gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain?in vitro?diagnostic medical devices).? In the event of an interruption or suspension of the supply of certain devices, the Article 10a obligation covers how these notifications are to be made and the activation of EUDAMED's existing modules. This amendment, especially the part related to Article 10(a), is of particular importance for medical device manufacturers. EU Regulation 2024/1860 ?????????????? ???? ???????????????????? ???? ?????????????? ???????????? ?????????????????????????? ???? ???????????? ???????????????????? ?????????????? ???????? ?????????? ???? ???? ???????????????? ???????????????????????? ???? ???????????????? ???? ?????? ???????????? ???? ??????????????. This obligation will ensure transparency and preparedness, particularly where such supply problems could pose a serious risk to patient health or lead to disruption of public health services.? ? According to the amendment, the manufacturer needs to assess the ?????????? ???? ?? ???????????? ???????????????????? ???????? ???? ?????????????? ???????? ?? ????????-?????????? ????????????????. In this context, the assessment of suppliers gains importance. Risks caused by problems in the supply chain should be anticipated. The most effective way to predict risks is to ensure that suppliers are effectively evaluated, and supplier audits are carried out effectively. For more detailed guidance, you may refer to the full text of Regulation 2024/1860 and questions & answers document “Q&A Obligation to inform in case of interruption or discontinuation of supply” on the European Commission’s website.?? ? https://lnkd.in/eGvyHuma? https://lnkd.in/epPNZuWd? ? Attached a document containing the main key points.? ? If you have any question for our? team, do not hesitate to contact us at ??????????????@????????.??????? For more information visit our website kiwa.com/medical. #Kiwa #KiwaMedical #MedicalDevices #obligation #criticalsupplier #amendment #MDR #MDCG #Q&A #Guidance?

By understanding these complexities and adhering to the relevant regulatory requirements, manufacturers can successfully bring innovative combination products to market while ensuring patient safety and regulatory compliance.

???????????????????? ?????? ?????????????? ?????????? ???? ?????????????????????? ???????????????? ?????????? ???? ?????? ? Combination products, a blend of devices and drugs or other devices, are revolutionizing healthcare. However, their regulatory landscape can be intricate. ? ? ?????? ???????????????????????????? ?????? ?????????????????????? ???????????????? ?????????? ???? ??????: ? ???????????????? ?????????????? ?????????? ???? ?????????????????????? ????????????????: ? ??Drug-Device Combinations (e.g., pre-filled syringes, drug-coated stents) ? ??Device-Drug Combinations (integral, co-packaged, cross-labelled) ? ??Device-Device Combinations (e.g., ventilator with oxygen concentrator) ? ??Borderline Products (difficult to classify as device or medicinal product) ? ? ???????????????????? ???????????????? ?????? ????????-???????????? ????????????????????????: ? ??Integral Products (MDR compliance and Notified Body surveillance) ? ??Co-packaged and Cross-labelled Products (varies based on primary ??function, medicinal or device related) ? ??Medicinal Products with an Ancillary Device (primarily governed by medicinal product regulations and the device component verified under the medical device regulation) ? ??Medical Devices Incorporating a Medicinal Substance (MDR Article 117, notified body evaluation) ? ? ???????????????????? ???????????????????? ??????????: ? ?????????????????? ???????? ??????????????: Crucial for combination products where the primary mode of action is device-related ? ???????? ????????????????????????: Required for devices containing ancillary medicinal substances ? ? By understanding these complexities and adhering to the relevant regulatory requirements, manufacturers can successfully bring innovative combination products to market while ensuring patient safety and regulatory compliance. ? ? Sources: MDR article 117 & Directive 2001/83/EC and Regulation 726/2004/EC. ? ? #KiwaMedical #Kiwa?

Last day of Medica, lots of steps and lots of catching up with Companies and colleagues. Exhausting but fantastic 3 days. (Photo from yesterday) Alison Hinchliffe Marine Debaut Reija Poikonen #kiwamedical #kiwauk #medica

?????? ???????????????? ???????????????????? ?????? ?????????????? ?????? ?????????????????????? ???? ?????????????? ???????????????? ?????? ???????????? ???????????? ?????????????????????? (????????) ???? ?????????????? ??????????????! ???????????? ???????????? ?????????????????????? (????????) ?????? ?????????????????? ?????????? ?????? ?????????????? ???????????? ???????????????????? (??????) ?????? ?????????????? ?????? ??????????????: 1. ???????????????? ????????????????????????: UDIs enable precise tracking of medical devices throughout their entire lifecycle, from manufacturing to distribution and patient use.? This improved traceability is crucial for identifying the origin and history of a specific device, which is essential for post-market surveillance and recall management. 2. ???????????????? ?????????????? ????????????: UDIs facilitate timely and accurate identification of devices involved in adverse events or product recalls.? This information can help healthcare providers and regulatory authorities take swift action to protect patient safety. 3. ?????????????????? ????????-???????????? ????????????????????????: UDIs enable more effective monitoring of device performance and potential safety issues. By analyzing data associated with specific UDIs, regulators can identify trends and take proactive measures to address emerging problems. 4. ???????????????????????? ???? ???????????????? ???????????????? ?????? ???????? ????????????????: UDIs can be used to link clinical data to specific devices, enabling researchers to analyze device performance and outcomes more accurately. This information can contribute to the development of evidence-based guidelines and improved patient care. 5. ?????????????????? ?????????????????????? ??????????????: UDIs make it more difficult to counterfeit medical devices by providing a unique identifier that can be verified. This helps protect patients from potentially dangerous counterfeit products. In summary, ???????? ???????? ?? ?????????? ???????? ???? ???????????????? ?????? ???????????? ?????? ???????????????? ???? ?????????????? ??????????????. By improving traceability, facilitating post-market surveillance, and enhancing patient safety, UDIs contribute to a more robust and reliable medical device ecosystem. The European Commission has renewed the designation of issuing entities for Unique Device Identifiers (UDIs) in medical devices. This means continued stability for UDI assignment for the next five years. (? Until June 27, 2029) ???????????????? ?????????????? ???????????????? ???????????? ?????????? ????????????????????????:?? ? GS1 AISBL? ? Health Industry Business Communications Council (@HIBCC)? ? ICCBBA? ? Informationsstelle Für Arzneispezialit?ten Ifa GmbH Want to learn more about UDIs and issuing entities?? https://lnkd.in/e_desgnZ #KiwaMedical #Kiwa?

?????? ?????????????? ???????? ???? ???????????????? ???????????????????? ?????????????? (????????) ???? ?????????????? ???????????? ?????????????????????? A Clinical Evaluation Report (CER) is a cornerstone in ensuring the safety and efficacy of medical devices. It provides a comprehensive assessment of clinical evidence, supporting the device's intended use. Key points from a CER:? ?? Clinical Data: Includes data from clinical investigations, literature reviews, and post-market surveillance.? ??Safety and Performance: Demonstrates sufficient evidence to verify safety, performance, and clinical benefits.? ??Regulatory Compliance: Required for most medical devices in the EU under the MDR.? ??Technical Documentation: Part of the Technical Documentation, subject to Notified Body audits.? ? How to Prepare a CER:? ?? Clinical Evaluation Plan (CEP): Define scope and approach.? ?? Data Identification: Gather relevant clinical data from various sources.? ?? Data Appraisal: Assess quality, relevance, and validity.? ?? Evidence Articulation: Demonstrate sufficient evidence for each General Safety and Performance Requirement (GSPR).? ? Key Components of a CER:? ?? Device description and intended use? ?? State of the art and alternatives? ?? Summary and appraisal of clinical data? ?? Data analysis to demonstrate conformity with GSRPs? ?? Conclusions? ?? Evaluator qualifications? ? Ongoing Updates:? ?? Regular updates throughout the device lifecycle? ?? Updates based on new PMS or PMCF data ????????????????: A well-prepared CER is essential for regulatory compliance, patient safety, and market success. Questions? Contact us at ??????????????@????????.?????? #Kiwamedical #Kiwa #medicaldevices??

?? Today, Kiwa Suomi ′s #MDR webinar welcomed an international guest! Ana Pina, Kiwa Medical Global Business Sector Lead, joined us to share key updates on MDR this fall, along with an overview of Kiwa's notified bodies (#nobo) and the certification process. ?? A link to the event recording will be sent to all registrants. ?? Thank you all! In the photo, our fantastic #kiwa event team— Aino Salste, Juha J?rvinen, Reija Poikonen, and Ana Pina—celebrate a successful and insightful session. ?? ?? Follow Kiwa Medical to stay up-to-date with the latest MDR news! #KiwaMedical #Certification #MedicalDevices #sharingiscaring

Post-market surveillance (PMS) has undergone significant transformation under the Medical Device Regulation (MDR) in Europe. It marks a new era in the monitoring and reporting of medical device safety and performance. This set of requirements emphasizes the proactive collection and analysis of medical device-related data after a product is placed on the market, allowing manufacturers to reassess the safety and effectiveness of their medical devices continuously. ?? Read more about '????????-???????????? ????????????????????????: ?????? ???????????????????????????? ?????? ?????????????? ???????????? ????????????????????' in our latest article: https://lnkd.in/ee_n5ru6 #KiwaMedical #PostMarketSurveillance #MedicalDevices #MedicalDeviceCompliance