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 manufacturer is also placing devices into any of the markets of the MDSAP RA’s (USA, Canada, Australia, Japan, Brazil).
Can you explain how the CE mark program changes with the EU MDR?
Brooks: From 30,000 feet, the CE process looks similar, but the changes in the details are significant (changes to safety performance requirements, clinical expectation, labeling, technical documentation, postmarket requirements, etc.). Every device will be impacted.
What is the difference between an MDD recertification and MDR certification? What should companies pursue?
Brooks: New MDD CE certification is only available until 2020, [and] then MDR certification will be required for all new devices. Legacy MDD devices will have additional time to transition to being under MDR certification.
Your report mentions a “gap analysis.” What would a gap analysis include, and who would it be provided to?
Brooks: Gap analysis can be conducted by trained internal or external (consultants). The specific scope would depend on many variables (experience, classification, number of legacy devices, available/quality clinical data, compliance with state of the art). During transition, lots of guidance is not yet available, so [the] judgement of experts is critical to ensure gaps are correctly identified and addressed.
What do you expect will happen with notified bodies and how would this impact medical device manufacturers?
Brooks: MDR notified bodies will probably not be designated until early 2019. Capacity and experience will be a significant concern—there will most likely be a much smaller pool of NBs under the MDR compared with under the current MDD.
How have the requirements for clinical evidence changed, for new products as well as for already marketed products?
Brooks: More prescriptive clinical requirements require more data and evaluation for all new and MDD legacy devices.
What should medical device manufacturers do to prepare their data for the EUDAMED?
Brooks: Understand the expectations and prepare the data, irrespective of whether EUDAMED is functioning to receive the data. Manufacturers must address the data requirements and have [their data] available.
For more details from the survey by RAPS and KPMG, visit “The Race to EU MDR Compliance.”