To help businesses maintain momentum in their MDR preparations, RQM+ has released a new white paper, focusing on Post Market Clinical Follow-up (PMCF).
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Following a challenging year, this paper from the international consultancy provides a clear and positive planning strategy to keep businesses on track with their PMCF efforts, drawing attention to common pitfalls encountered by medtech companies.
The delay of the MDR deadline to May 2021 provided welcome relief to the industry, allowing businesses to focus on managing the impact of the pandemic. It is critical, however, that medical device companies do not fall behind in their compliance activities, as they continue to face ongoing pressures. The positive message of this paper is that in these demanding circumstances, good planning will deliver optimal results in PMCF compliance.
The MDR significantly raises the bar for the quantity and quality of clinical data required for PMCF. As this is a new level of clinical evaluation, many businesses are experiencing similar challenges. This white paper outlines three major pitfalls which medtech companies are often falling into, as well as best practices to avoid these common hurdles. A planning strategy based on these best practices will help companies to develop a strong rationale for PMCF activities, that can then be clearly presented to a notified body.
Lisa Casavant, Executive Vice President at RQM+, comments: “We’re aware that businesses may be under significant budgetary constraints in light of the pandemic, but this doesn’t mean that quality will have to be sacrificed. The key is to prioritise PMCF preparation efforts and get started as soon as possible.
"We hope that this paper will support these efforts by providing some of the best practices, lessons learned, and collective knowledge from our regulatory, clinical, and former notified body experts who have supported our clients with MDR implementation over the last few years. At this critical juncture for MDR compliance, these lessons are invaluable in avoiding failed regulatory submissions and the resulting consequences.”