RQM+ releases new whitepaper to assist medtech businesses with MDR compliance activities
Medical device and diagnostics-focused consultancy RQM+ has released a new white paper which could help medical device manufacturers in the mobility sector comply with meeting the European Union’s Medical Device (MDR) regulations.
The new white paper focuses on Post Market Clinical Follow-up (PMCF) – investigations which must be carried out by manufacturers to collect additional information about devices which have reached the EU market.
The white paper, Three key stages – Three common pitfalls: Post-Market Clinical Follow-up under MDR provides a planning strategy to keep businesses on track with their PMCF efforts.
It draws attention to three major pitfalls encountered by medtech companies and advises on best practices to avoid these common hurdles.
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.
As the MDR significantly raises the bar for the quantity and quality of clinical data required for PMCF, RQM+ say that it is critical that medical device companies do not fall behind in their compliance activities, as they continue to face ongoing pressures.
A planning strategy based on best practices, it says, 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 prioritize 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.”
The spectre of EU MDR regulations has been looming large over the medical device industry over the past year, with further regulations coming down the pipeline for different types of medical devices in the coming years.
According to a recent report, 44 per cent of medical device organisations admit MDR regulations are a top priority.
