Educo Life Sciences’ Post

Hurry up and reserve your seat in the next round of the EU MDR Medical Device Regulation 2017/745 Essentials Course from SchoMedX Academy 🔔 ✨ 💫 The course will explain the essentials of (EU MDR) 2017/745 such as the improvements in the EU MDR, the technical files elements, post-market responsibilities, increased requirements related to market actors, etc. Upon completion, this course will equip all professionals in the medical devices industry with the qualifications needed to work efficiently in the Regulatory department. Our focus on the implementation process through various case studies will ensure thorough understanding and practical application of the knowledge gained. Tutor Profile: https://lnkd.in/daWY_tTn Hurry up and reserve your seat: 👇 https://lnkd.in/dZjDVX29   Don't miss to ask about our first birthday offer 👏🎉 #مبادرة_علمنى_medicaldevice_بالعربي  #medicaldevices #SchoMedXacademy #trainingcourses #freshgraduate #students #science #medicaleducation #medicaldeviceindustry #medicaldevicemanufacturing #medicaldevicejobs #iso13485 #MDR

⭐ ⭐ ⭐ ⭐ ⭐ Read the latest testimonials to see what our previous attendees thought of the course Labelling & UDI for Medical Devices and IVDs which is due to run again this July 8. #educolifesciences #medicaldevicetraining

🔈 The European Parliament resolution of 23 October 2024, calls for an urgent revision of the Medial Devices Regulation. Some of the proposals are:  🔹 Proposal for delegated and implementing acts for the MDR and IVDR to address the most pressing challenges and bottlenecks in the implementation of the legislative framework. 🔹 Transparency in notified bodies´ fees and fee structures. 🔹 The need to eliminate the entire recertification of certain products that have undergone certain updates or adjustments. 🔹 Strongly calls for fast-track and prioritisation pathways for the approval of innovative technologies #EuropeanParliament #medicaldevices #IVDR

Do new regulations for EUMDR reduce the risk of Medical devices compared to old MDD Directives? EUMDR impact on Risk Reduction #EUMDR2017/745 #MDD #Riskreduction #effectiveness #comparision #EUMDRImpactonriskreduction The European Medical Device Regulation (EU MDR) aims to enhance the safety and effectiveness of medical devices while ensuring a high level of protection for patients, users, and public health. While it's expected that the EU MDR will contribute to reducing certain risks associated with medical devices, it's essential to understand that regulations alone cannot eliminate all risks. Here's how the EU MDR may contribute to reducing risks associated with medical devices Certainly, here's a comparison in tabular form highlighting how the new regulations under the EU Medical Device Regulation (EU MDR) may contribute to reducing the risk of medical devices These measures collectively aim to enhance the safety and effectiveness of medical devices, reduce risks associated with their use, and ensure a high level of protection for patients, users, and public health within the European Union.

MDD to MDR Transition While most medical device manufacturers have likely implemented the MDR by now, some may still be working towards compliance or planning to enter the EU market. If you are one of them, this post is for you! I recently discovered a helpful #gapassessment document that clearly compares the requirements of the MDD (93/42/EEC and 90/385/EEC) and the MDR (2017/745). It also highlights any changes implemented in the MDR and provides specific details. The real power of this tool lies in its ability to define the necessary steps to achieve and maintain compliance with MDR 2017/745, track the progress towards MDR compliance, and highlight any remaining hurdles along the way. The excel file can be download here: https://lnkd.in/dspPKFWW If you find this post helpful, please like and repost! In the comments below, let me know what other regulatory topics you'd like me to cover in future posts. #mdr #medicaldevices #regulatoryaffairs

Do you have SW as Medical device in market? And is your product to upclassify to class IIA or IIB according MDR? Still few days until 26.5 to file your application to Notified Body, but the time is running out. In case you already decided that product will discontinue, as many companies most likely have decided due increasing compliance costs and efforts, this is fine with the strategy. In case the plan is to continue in business with your SaMD, you should really act latest now. I just checked there are only few Finnish Software as Medical device (SaMD) companies, who have been able to upclassify their products since 2021. They are 3 companies. Alltogether 13 Finnish companies with SaMD products registered in MDR in Eudamed (some had already products in class IIa or IIb in MDD). I keep fingers crossed, that rest of the software (specifically as they need too upclassify) companies have filed their application. But this article and discussions with Notified body makes me concerened. This decade is the real peak years for healthcare information system developers to adaptation of increasing regulation! In the sense that the requirements of the reforming and new laws should be taken over (MDR and now coming Ai Act and EHDS). It has been 7 years of preparation time for the MDR transition next week, and now we can find out where we are going on with the industry able to adapt to new regulation. From the point of view of number of already Software as medical certified devices, the situation looks bad, the hope is still that there are many products moving to class II in the processing of the Notified Bodies.  Based on this article and discussions with notified bodies, the situation is not necessarily under control of all companies. #MDR #AIACT #EHDS

European Parliament resolution on the urgent need to revise the Medical Devices Regulation - 23Oct24 - 2024/2849(RSP) "Calls on the Commission to propose, by the end of Q1 2025, delegated and implementing acts to the MDR and the IVDR to address the most pressing challenges and bottlenecks in the implementation of the legislative frameworks and to propose the systematic revision of all relevant articles of these regulations, accompanied by an impact assessment, to be conducted as soon as possible" 2025 will be another interesting year, more to come... #Medicaldevice #MDR #IVDR #Clinicalresearch https://lnkd.in/eGhrcnJ5

Ever wondered about the significance of MDR Technical Documentation for Medical Devices? Delve into its purpose, the latest regulatory changes, and the crucial components that make-or-break compliance. Seeking clarity or need expert guidance for your project? Let's talk about your Medical Device journey!    https://lnkd.in/dRPreG28 Get connected:  Mail ID: enquiry@operonstrategist.com    Phone no: +91 9370283428   .   .   .   #MDRCompliance #MedicalDeviceRegulation #TechDocsInHealthcare #CEMarking #MedicalDeviceApproval #RegulatoryChanges #HealthTech #MedTechInsights #EURegulations #healthcareinnovations #government #medicalequipment #operonstrategist #consultation #consulting 

Healthcare professionals, have you noticed the new symbols for medical device labelling? 🏥🔍 The Medical Devices Regulation (MDR) introduced new compliance requirements for labelling. With 24 official languages in the EU, internationally recognised symbols are the ideal tool to streamline communication. What do you need to know about the new symbols on medical device labels? ➡️Purpose: These symbols convey essential information as required by the MDR. ➡️Scope: Symbols cover various aspects such as device identification, sterile conditions, and economic operators. ➡️Environmental Impact: Use of symbols reduces the need for extensive text translations, simplifying information delivery. ➡️Implant Cards: For implantable devices, symbols on implant cards ensure patients and HCPs have all the necessary details. Stay informed about these changes by checking our factsheet 📄 https://bit.ly/3VnszJh

📣 On 16 October, the Medical Device Coordination Group (MDCG) released an updated guidance document titled "MDCG 2021-25 Rev. 1." ℹ The document offers updated guidance on the applicability of the Medical Device Regulation (MDR) requirements to 'legacy devices' and 'old' devices. For clarity and reference, the annex includes a non-exhaustive table that illustrates which MDR requirements apply or do not apply to 'legacy devices'. Substantial changes are in particular in sections 3.1, 3.2 and 4, namely: - clarification that Article 19 MDR does not apply to legacy devices; - clarification of the application of the transitional provisions to systems and procedure packs covered by a declaration drawn up pursuant to Article 12(2) MDD; -clarification regarding the requirement to put in place a QMS in accordance with Article 10(9) MDR. 🔗 Link to document: https://lnkd.in/eU9nzKMS