Watercooler conversations January 22, 2024
Here's what they discussed:
1️⃣ Their Journey into Regulatory Affairs
Panelists shared their own stories about how they came to work in regulatory and clinical affairs. Despite arriving “by accident,” many said their sustained engagement has been fueled by the potential that medical devices hold to enhance lives and healthcare outcomes significantly.
2️⃣ Early Interaction is Key
The dialogue spotlighted the need for early communication between manufacturers and Notified Bodies under the MDR, emphasizing that this will bolster both innovation and confidence by ensuring alignment with regulatory expectations.
3️⃣ MDR’s Impact on Clinical Studies
Discussion elucidated the MDR’s more stringent and prescriptive requirements, propelling a shift towards randomized trials and influencing the approach and design of clinical studies.
4️⃣ Unique Device Identifiers (UDIs)
The need for distinct UDIs for devices and procedure packs brought forth interesting discussions. Especially that every component within a system or pack necessitates its own UDI, alongside the UDI for the overarching system/pack, thereby ensuring traceability and clarity.
5️⃣ Predictions on MDR Evolution
Predictions about the MDR’s trajectory in the short to mid-term were postulated, hinting at developments concerning clinical requirements, procedural points, transitional regimes, and exploring potential friction points between manufacturers and notified bodies.
6️⃣ Need for Harmonization in MDR Implementation
Desires for more clarification, simplification, and harmonization within diverse facets of MDR implementation were voiced, pinpointing needs across classification discussions, guidance packages, and member state stances on topics like notified body designation.
7️⃣ Software Device Regulatory Challenges
Exploring regulatory challenges, the dialogue veered towards software devices and products, identifying deficiencies such as undefined indications and patient populations and incorrect application of provisions like Article 61 (10), highlighting the criticality of proper understanding and application of regulations to navigate through regulatory processes effectively.
🔥 See the FLIPBOOK Below 🔥
A hearty thanks to all the panelists for their candid insights, including Sabina Hoekstra-van den Bosch, PharmD FRAPS, Natascha Cuper, Leon Doorn, Erik Vollebregt, Giovanni Di Rienzo, Sue Spencer, Armel Plaine, and Agnieszka Schreiber.
Source & attribution: https://www.linkedin.com/posts/sean-smith007_debating-eu-mdr-gray-areas-unicorns-and-ugcPost-7119072338171588610--uei/?utm_source=share&utm_medium=member_desktop
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