Verbatim Pharma’s Post

🚩 Not all is well in the state of MDR What are the challenges faced in implementing the #MedicalDevicesRegulation? And what can we do to address them? Read our new White Paper and find out our proposed reforms to enhance the regulatory framework: https://ow.ly/bFQu50RkV6p

Clearing your medical device in Europe has become a more complex process. Learn how to prepare the necessary clinical evidence and technical dossier for a successful outcome.

Annette Van Raamsdonk, from the Emergo by UL’s team, live on January 17, 2024 from 9 – 9:45 AM CST as she shares insights on what has changed with the adoption of Regulation 2023/607. In this presentation, the presenter will summarize: - What has changed with the adoption of this regulation - How can you determine whether you are eligible for the extension - Who can make use of the extended deadlines to transition to the MDR. Register today: https://s.ul.com/3NYpQn0 #regulatory #regulatorycompliance #webinar #medicaldevice #marketaccess #EU #weareULSolutions

Annette Van Raamsdonk, from the Emergo by UL’s team, live on January 17, 2024 from 9 – 9:45 AM CST as she shares insights on what has changed with the adoption of Regulation 2023/607. In this presentation, the presenter will summarize: - What has changed with the adoption of this regulation - How can you determine whether you are eligible for the extension - Who can make use of the extended deadlines to transition to the MDR. Register today: https://s.ul.com/3NYpQn0 #regulatory #regulatorycompliance #webinar #medicaldevice #marketaccess #EU #weareULSolutions

Discover the difference between MDD and MDR including how professionals are navigating the complexities of the regulatory landscapes, adhere to compliance requirements, and contribute to the delivery of safer and more innovative medical devices to patients worldwide. Check out the article here: https://lnkd.in/ey65ZmwV #Compliance #Medical #Health #FDA

Learn about the upcoming EU MDR requirements that could impact your MedTech products. Our latest blog offers a guide to staying ahead of compliance issues. We can help you in your EU MDR transition journey. DM for more information.

Annette Van Raamsdonk, from the Emergo by UL’s team, live on January 17, 2024 from 9 – 9:45 AM CST as she shares insights on what has changed with the adoption of Regulation 2023/607. In this presentation, the presenter will summarize: - What has changed with the adoption of this regulation - How can you determine whether you are eligible for the extension - Who can make use of the extended deadlines to transition to the MDR. Register today: https://s.ul.com/3NYpQn0 #regulatory #regulatorycompliance #webinar #medicaldevice #marketaccess #EU

The Medical Devices (Amendment) (Great Britain) Regulations 2023    On 9th June 2023, the UK government published a statutory instrument amending the UK Medical Device Regulation (2002). This publication was released after public consultation and has been approved by each UK House of Parliament. These Regulations amend the Medical Devices Regulations 2002 to extend the periods for which certain medical devices that comply with EU legislation can be placed on the market in Great Britain. The amendments to regulations 19B, 30A and 44ZA provide that certificates issued under Directive 90/385/EEC, Directive 93/42/EEC or Directive 98/79/EC that remain valid by virtue of the transitional provisions in Regulation (EU) 2017/745 or Regulation (EU) 2017/746, are considered valid for placing devices on the market in accordance with regulations 19B, 30A and 44ZA. Irrespective of these amendments, manufacturers need to ✔ Manufacturers of Class I devices that do not require notified body involvement under the EU MDD or the EU MDR must act now to ensure compliance with either the EU MDR or UK MDR 2002 prior to placing devices on the UK market. ✔ Make sure your Quality Management Systems are in Place. ✔ Ensure appropriate Transition plan from EU Medical Device Directives [EU MDD] to EU Medical Device Regulation in accordance with UK Medical Device Regulation are in Place. ✔ Contact Experts at Med-Di-Dia who can support you with completing your transition plans, technical files and documents. ✔ If you are yet to launch your medical device on the EU or UK Market, speak to our experts, who can create a comprehensive Regulatory Roadmap for a smooth launch. We are here to be your Regulatory Risk Partners for Medical Devices, Diagnostics and Digital Health!   Drop us an email at mdd@mddltd.com or fill out an interest form https://lnkd.in/gEMGNiNn #YouInnovate we shall partner your #RegulatoryCompliance #MedDiDia #PRRC #EUAR #USFDA #MDR #IVDR #MedicalDevices #Diagnostics #DigitalHealth #QMS #UKCA #UKRP #medicaldevice #management #compliance #quality #PersonResponsibleForRegulatoryCompliance #CyberSecurity #RegulatoryAffairs #MDCG #IVDRReady #MDRChampions

Annette Van Raamsdonk, from the Emergo by UL’s team, live on January 17, 2024 from 9 – 9:45 AM CST as she shares insights on what has changed with the adoption of Regulation 2023/607. In this presentation, the presenter will summarize: - What has changed with the adoption of this regulation - How can you determine whether you are eligible for the extension - Who can make use of the extended deadlines to transition to the MDR. Register today: https://s.ul.com/3NYpQn0 #regulatory #regulatorycompliance #webinar #medicaldevice #marketaccess #EU #weareULSolutions

𝐌𝐃𝐑: Are you ready? As the healthcare industry continues to evolve, so do the regulations governing medical devices. The transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) represents a paradigm shift for manufacturers, regulatory authorities, and Notified Bodies. Let’s explore why regulatory activity is crucial and the challenges posed by this transition: 1.    𝐏𝐚𝐭𝐢𝐞𝐧𝐭 𝐒𝐚𝐟𝐞𝐭𝐲 𝐅𝐢𝐫𝐬𝐭: Regulatory frameworks exist to safeguard patient safety. The MDR enhances clinical safety by imposing stricter requirements on medical devices, ensuring they meet the highest standards. 2.    𝐌𝐚𝐫𝐤𝐞𝐭 𝐀𝐜𝐜𝐞𝐬𝐬 𝐚𝐧𝐝 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞: Manufacturers must proactively adapt to MDR requirements. Compliance measures include clinical evaluations, risk assessments, and post-market surveillance. Collaborating closely with regulatory bodies and Notified Bodies is essential for successful market access. 3.   𝐂𝐨𝐥𝐥𝐚𝐛𝐨𝐫𝐚𝐭𝐢𝐨𝐧 𝐚𝐧𝐝 𝐄𝐝𝐮𝐜𝐚𝐭𝐢𝐨𝐧: Healthcare professionals, manufacturers, and regulators must work together. Training programs, workshops, and knowledge-sharing sessions facilitate a better understanding of MDR requirements. 4.    𝐒𝐮𝐩𝐩𝐥𝐲 𝐂𝐡𝐚𝐢𝐧 𝐑𝐞𝐬𝐢𝐥𝐢𝐞𝐧𝐜𝐞:The MDR aims to address shortages of medical devices by ensuring a robust supply chain. Manufacturers need to adapt swiftly to maintain market availability. 🚀 𝐋𝐚𝐥𝐥𝐞𝐦𝐚𝐧𝐝 𝐏𝐡𝐚𝐫𝐦𝐚 and its RA team is embracing these changes, safety, and collectively navigate the evolving regulatory landscape 💪 Do not hesitate to reach us and our RA team to get more news! #HealthcareRegulation #MDRTransition #PatientSafety #MedicalDevices