8 Things You Should Know about the EU MDRs

A recent survey by the Regulatory Affairs Professionals Society (RAPS) and KPMG revealed some shocking statistics. According to “The Race to EU MDR Compliance,”a solid majority (78%) of medical device companies responding to the survey do not have a sufficient understanding of EU MDR. And even more shocking: more than half of respondents (58%) have no strategy in place to remediate gaps in their clinical data or processes for collecting data, despite the new regulatory expectations for such data. Education is clearly still needed to help companies prepare for May 2020, when the EU MDRs begin taking effect, so we asked Paul Brooks, executive director, RAPS, a few questions.   Your report mentions aligning cross-functional resources and teams to prepare for the EU MDRs. Why is this needed? Brooks: Preparing for the MDR may be led by RA [Regulatory Affairs], but [it] will significantly impact other departments (R&D, clinical, quality, purchasing, customer service, marketing, etc.). It’s important that all relevant departments understand the changes and provide input from their perspectives.   How would the Medical Device Single Audit Program (MDSAP) help with compliance with the EU MDR? Brooks: Addressing QMS requirements with an all-inclusive perspective may be more efficient to avoid multiple revisions and duplications. Addressing the QMS requirements of the MDR and MDSAP makes sense if a manufac...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news