Regulatory bodies such as FDA, IMDRF and HMA and others are refocusing compliance requirements for the medical technology industry. In a global marketplace, not complying to regulatory changes can result in fines and penalties with an impact on companies' bottom line as well as loss of market access.
With the introduction of the new Medical Device Regulation (MDR), and the pending In Vitro Diagnostics Regulation (IVDR), the regulatory landscape in the EU has undergone tremendous change. The new situation gives rise to uncertainties and unknowns and it will take time before it settles and becomes predictable again.
In 2020 the MDR was updated requiring medical device manufacturers to provide clinical data obtained via post-market clinical follow-up (PMCF) to confirm device safety and clinical performance, ensure continued acceptability of identified risks, and detect emerging risks on the basis of factual evidence.
The changes are intended to enhance product quality and safety. They're also meant to give better insight into the entire product lifecycle via improved quality metrics and inspection process.
Following the new MDR changes and ISO 13485, companies have been evaluating the required investment to comply with the new regulatory requirements. In some cases, the cost and complexity of compliance, including expansion of regulatory teams, has reached hundreds of millions dollars as they required to perform changes within the medical device,such as adding connectivity.
Preparedness varies based on company size. Large companies appear to be more equipped to identify, execute and manage the updating process. Small size companies are struggling to execute the required changes and ultimately, they may not have enough resources, budget or time to meet the EU MDR deadline.
The new regulations bring substantial changes to how medical devices are brought to and maintained in the market. The increased requirements for clinical evidence under the MDR will have a major impact on medical device design. Running more trials will require larger investments, as well as produce a corresponding need to ensure that data is collected, stored, and available in a way that can be used easily and transparently to demonstrate compliance.
Achieving compliance with MDR dovetails perfectly with the new generation of healthcare companies that have already adopted new technologies such as the Internet of Things (IoT).
IoT technology enables medical devices manufacturers to track the devices, streamline collection of information (usage, patient feedback and patient outcome) not only with the purpose of meeting the PMCF requirements but to truly understand how their device is being used, affect on patients and validate products functionality.
Regardless of the size of the organization, it’s very often that existing internal teams lack the knowledge required to meet the new regulation requirements. This is why so many medical device companies are enlisting the help of external resources, which offer the expertise and the solutions needed to comply with these evolving regional and international regulations.
Achieving MDR compliance will be considerably simpler once companies have implemented new technology.
BioT is a no-code and open cloud-based platform for medical device manufacturers, designed to instantly connect patients with caregivers to ensure a seamless continuum of care. The platform is deployed per device manufacturer, as a service model (Platform as a Service). It can be fully customized per manufacturer needs using no-code or low-code methods. Using BioT’s platform, patient and other sensitive data is stored encrypted and secured, complying with strict regulations (HIPAA & GDPR). Access-based attribute control is used to ensure that permissions are granularly granted only to relevant entities, each to specific and relevant data, per role - caregivers, administrators, organization owners etc. BioT streamlines the tedious registration processes by automating the PMCF data collection providing several tools:
Embedded questionnaires - Provide automated questionnaires mechanism, to collect data on device usage, patient feedback and patient outcomes as part of the PMCF requirements.
Calculate sample size - providing the data required to accurately calculate the sample size for medical devices clinical investigation
Events reporting - recording and reporting of adverse events (AE) and serious adverse events (SAE) is a key aspect of a successful clinical investigation
In addition to PMCF medical device manufacturers are required to comply with HIPAA & GDPR requirements. When choosing to adopt BioT as a platform, manufacturers sign a Data Processing Agreement (DPA) to regulate personal data processing and a Business Associate Agreement (BAA) to create a bond of liability between both parties as required by HIPAA and the FDA.
BioT complies with ISO standards and supplies manufacturers with Design History Files (DHF) required in 21 CFR part 820 of the FDA.