Focus on the NB Designation Status & Timeline, Rationale for Prioritization of Specific Product Line Compliance with New Rules & Management of Remaining Tasks, all while Addressing Ongoing MDR Uncertainties in Finalizing the Updated Regulatory Strategy
With the MDR compliance date rapidly approaching, regulatory affairs executives are currently focused on organizing and managing final steps to align corporate strategies with new demands. Strategizing to best prioritize operations necessary to finalize the transition towards the new rules is at the forefront of the industry’s concern, and is challenged by a number of unknown factors that will ultimately influence strategies. Among current uncertainties, the status of notified body designations under the MDR is creating much concern, as manufacturers are anxious to plan for product recertification, which will be complex with a large volume of files submitted to a limited number of notified bodies. Further areas of compliance with new rules continue to lack clarity, such as EUDAMED readiness, defining sufficient clinical evidence or the life-cycle approach to post-market surveillance coupled with the practical application of economic operators’ verifications.
As manufacturers aim to finalize compliance for the most pressing product lines first, such as most Class I, or devices with MDD certificates ending close to the spring of 2020, many professionals are eager to obtain insight from similar industry experiences in order to compare and debate time and cost-effective strategies. Once more, the Q1 Productions EU Medical Device Regulatory Affairs conference will include insightful formats to enable high-level presentation learning as well as peer-to-peer sharing, allowing each participant to take away practical insight from other organizations’ experience. In addition, a comprehensive blend of speakers including authorities, notified bodies as well as industry experts promise comprehensive and targeted approaches to the most burning topics for forward-thinking regulatory affairs professionals.