CiteMed have built sophisticated software platforms in order to increase efficiency and decrease costs/timelines for device manufacturers
In light of the disruptions caused by the COVID 19 pandemic, the postponement of the EU MDR brought a much needed respite to an already overstrained medical devices industry that already had been unable to focus efforts towards compliance with the impending and complex regulatory overhaul. Innovative newcomer firms such as Cite Medical (CiteMed) have found their stride in becoming an answer to the industry's MDR problems.
Although this one-year deferral or ‘grace period’ aims primarily to provide manufacturers extra time to comply with the additional EU MDR requirements, many companies will still be behind on their road to compliance.
MDCG Guidelines Provide a Path to MDR Success
Under the EU MDR manufacturers are required to follow the Medical Device Coordination Group’s (MDCG) Post Market Clinical Follow-up plan (PMCF) and evaluation report templates as they prepare their Quality Management Systems (QMS) for enhanced scrutiny by Notified Bodies (NBs).
While manufacturers will benefit from the proposed delay to the date of application, they will have to adhere to the new, risk-based classification system in which certain, low-risk medical devices are to be moved into a higher-risk class; this includes certain software which are currently classified as Class I
Thus, in order to ensure compliance with the stricter classification system, companies that are presently developing software to be used in conjunction with medical devices, or as a standalone medical device, would need to keep these changes in mind as they introduce all necessary measures to handle increased involvement by the NBs as clinical trials are executed.