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.
Additionally, manufacturers will be required to extend MDD certificates, and comply with the increased requirements for clinical evidence for medical devices previously CE-marked under the MDD and demonstrating equivalence.
CiteMed’s Innovative Approach to Regulatory Affairs
Companies like CiteMed have built sophisticated software platforms in order to increase efficiency and decrease costs/timelines for device manufacturers. Their MDR Clinical Evaluation Reports and Literature Search process has seen growing interest from manufacturers.
“The new MDR has really boxed device manufacturers into a corner.” reflects Ethan Drower, a Partner at CiteMed. “Firms, especially smaller ones, simply don’t have the budgets or manpower to comply across their entire device portfolios in time”.
The EU MDR has raised the bar on not just the need for clinical evidence and evaluation, which translates to more stringent Post-Market Surveillance (PMS) requirements, but also the expected level of scrutiny leading to enhanced examination by NBs.
This may necessitate modification in CER processes and collection of additional data from clinical investigations, such as the grounds of establishing equivalence with another device, the quality of data and processes considered in the clinical evaluation.
CiteMed has devised and tested a template based system to streamline Post Market Surveillance processes, and has already contracted and used this process to successfully assist a large equipment seller to secure EU approvals for a number of products.
“Without a systematic approach, most firms will be plagued with Notified Body corrective actions and delays in their submissions” says Ethan.
Manufacturers Moving Forward with Caution
Manufacturers should begin with a general review of documentation for the date of application in May 2021and re-evaluate the CERs across their portfolios (which is especially important in cases where the initial CE marking was supported with limited, clinical data).
In order to establish equivalence, manufacturers must demonstrate that the device under evaluation is substantially equivalent in terms of safety and effectiveness to the aforementioned equivalent devices (termed predicates). Here, equivalent devices can be identified through a comprehensive literature review of devices having similar technical, biological & clinical specifications. Often a uniform review of sales literature from comparable products and services can contribute to an extensive and useful product review and provide an understanding as to the current state of the art.
It is in this area specifically that the CiteMed team is thriving. Their experienced Researchers use a proprietary platform designed with EU MDR literature search and clinical evaluation in mind.
“The results have been stunning”, writes Ethan Drower. “By focusing on Literature Search and CER, we’ve been able to cut timelines by an average of 80%. Allowing our clients to actually submit their documentation early”.
Additional Clinical Requirements Pose a Challenge
However, manufacturers who previously submitted only literature reviews containing existing clinical studies for equivalent devices will now also be required to carry out pre-market clinical studies for new technology and indications. Though such studies are time consuming and more expensive, under the EU MDR the use of scientific literature as a sole means for clinical assessment is strictly regulated.
The CER should include a comprehensive PMS plan detailing the activities and post-market clinical studies, such as PMCF, organized and developed in a uniform and smoothly reproducible process.
The impending implementation of the EU MDR will result in an inevitable shift towards heavier PMS requirements, among others, meaning more emphasis on risk management, post-market clinical evaluation and additional scrutiny by NBs.
Given the current adverse global scenario and increased requirements of the MDR, manufacturers must use this additional time to evaluate their MDR transition plan, taking into consideration their current MDD certificate expiration dates, and consult with their NB, for each of their devices, in order to understand if further MDD early renewal audits may be possible.
If used constructively, this extra time will help manufacturers get organized, put a better implementation system in place, enabling compliance with more stringent requirements for technical documentation and clinical evaluations. And, as noted here previously, a well organized response can also serve to enhance product development.
“We’re getting more experienced and more efficient with our process” reflects Mr. Drower. “We hope to see more Medical Device manufacturers adopting our approach and not only completing MDR submissions on-time but with high success rates as well.”
(Syndicated press content)
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