Marcus Torr’s Post

Danke Berlin, Danke Regulatory Affairs Professionals Society (RAPS)! 💡 Our PMCF team attended RAPS Euro Convergence last week, where the plenary session kicked off asked the question: "𝗜𝘀 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗮𝗳𝗳𝗮𝗶𝗿𝘀 𝘀𝗰𝗶𝗲𝗻𝗰𝗲 𝗼𝗿 𝗮𝗿𝘁?" We certainly believe there is an art to ensuring the approaches taken for MDR / IVDR compliance are appropriate! Here are four key learnings that our team observed from the event and shared with us 💡 Marcus Torr / Tonika Chester / Chris Webb / Alice Robertson #RAPS #RAPSEuroConvergence #pmcf #pmcfsurveys

Regulatory Affairs Professionals Society (RAPS) once again put on a great RAPS Euro Convergence, with lots of insightful talks and some great networking opportunities! 👇Here are some of our key takeaways from the conference 👇 If you attended, what were your takeaways?

We at Emergo by UL love global regulatory discussions. Two of our colleagues on our global vigilance team, Amelia Boldrick and our manager of the team Elizabeth Pugh, write about the International Medical Device Regulators Forum (IMDRF) Adverse Event Codes. Have you had much exposure to the IMDRF Adverse Event Terminology Working Group or the guidance (AE WG/N43)? Have you reviewed any of the corresponding Annexes of the IMDRF guidance, Annexes A-G? Are you aware of the other coding systems, some which use the IMDRF codes and some that do not? Did you know that the US FDA MDR Adverse Event Codes map to the IMDRF codes? Ever thought about the European Trending of Similar Incidents or Periodic Safety Update Reports and the relationship to IMDRF codes? This Regulatory Update addresses the above. Read it: https://lnkd.in/gpp_dKHG. Image from our Regulatory Update of the IMDRF Annexes. #regulatory #regulatoryaffairs #regulatorycompliance #AE #IMDRF #vigilance #EmergobyUL #weareULSolutions #welovewhatwedo #weloveglobalregulatory

At the half way point of Regulatory Affairs Professionals Society (RAPS) Convergence Montréal….here are some high level takeaways: 🍁 Regulatory professionals love throwing balls at a target (see below👇) 🍁 The challenges with the MDR are still a hot topic conversation (including concerns over innovation & orphan devices) 🍁 SMEs in particular are confused & worried about what actually is required of them 🍁 NBs are working together to provide harmonisation & their capacity is greatly increased 🍁 There is optimism that although these conversations will continue, the industry will be in a much better place, with greater clarity over the next 5 years Thanks Bassil Akra for moderating some excellent sessions! #RAPS #RAPSConvergence #pmcf #pmcfsurveys

To help you better understand the Regulatory landscape of the EU MDR and IVDR, join me and Dr. Ceren for a live webinar session on 17th April. We will specifically focus on classification and re-classification to clinical testing requirements, designating a Person Responsible for Regulatory Compliance (PRRC), and appointing a European Authorized Representative (EAR). Save your seat today! https://shorturl.at/nqOP6 #medicaldevices #ivd #eumdr #ivdr #amr #eu #row #regulatoryaffairs #freyrsolutions #webinar 

Upcoming Regulatory Affairs Professionals Society (RAPS) #virtual event! Scroll for more info 👇 💬 "In the popular television series 'Survivor,' contestants are left on an isolated island with the odds stacked against them; they fight for survival amid constantly changing rules. Without knowing how to navigate the 510(k) program, and what alliances are critical for survival, a medical device company is likely to be an early exit from the FDA island with little chance of being 'the survivor.' Gaining an understanding of the program and its evolving expectations is like being equipped with the clothes, shelter, tools, and food essential to survive on the show. Unlike TV—there is plenty of room for more than one to survivor!" The registration deadline may have passed, but it's still worth clicking for more info, and reaching out to see if there are extra spots available 👉 https://lnkd.in/gMmGUWhp #QRxPartners #QRxInforms #mlv #510k #medicaldevice #CE #regulatory #compliance #RAPS #quality #FDA

Navigating the complexities of EU MDR and IVDR compliance can be a daunting task. TÜV SÜD's Structured Dialogues\ allows customers the chance to clarify the timing, procedural, and regulatory aspects of the application process, forms, and submission documents prior to lodging a formal MDR or IVDR application with TÜV SÜD. Partner with TÜV SÜD today to navigate the EU regulatory landscape with confidence and clarity. MDR: https://lnkd.in/gdPeE8h3 IVDR: https://lnkd.in/g_Dz432b #TUVSUD #MedicalDeviceRegulation #MDR #StructuredDialogue #IVDR #NotifiedBody

Emergo by UL posts about the European Commission (EC) proposal to delay compliance of legacy IVDs and to permit compulsory use of individual modules within EUDAMED.   Thanks to our global regulatory team, and their ability to monitor regulatory developments, we share the official website where one can monitor the progress of this proposal.   In addition, with Ma. Klarizza Pacris and Annette Van Raamsdonk, we share an update of the progress with Council and the first reading: https://lnkd.in/gmDY3GFm .   Now onto the European Parliament.   Image of the progress of the procedure 2024/0021/COD.   Thank you to our marketing team for managing our regulatory updates: Kathy Burke, Stewart Eisenhart, and Khalid Mandil.   #medicaldevice #regulatory #regulatoryaffairs #regulatorycompliance #ivdr #eudamed #mdr #eudamed #EmergobyUL #weareULSolutions #welovewhatwedo #weloveglobalregulatory

Interested in the challenges and opportunities of the Regulatory Affairs landscape?💡 Hear from Prof. Dr. Rudolf Blankart from sitem-insel on the critical role of understanding Regulatory Affairs and how the MDRQ program equips professionals for an impactful future. 🚀 Watch the insightful video interview on our blog: https://lnkd.in/dJRKPP_D   #RegulatoryAffairs #MedicalTech #MDRQ #siteminsel

MDR and IVDR guidance planned for 2024 ⭐ The MDCG list of planned guidance, including revisions of existing documents, has been updated. The planned guidance cover topics such as post-market surveillance, clinical investigations and evaluation, and notified body oversight. https://lnkd.in/gj5ggyq2 #Medicaldevices #Diagnostics #EuropeanUnion #Regulatory #Compliance