Alwin van den Broek, Project Manager and Data Protection Officer
Anne Leijsen, Director, Medical Writing
Long before the pandemic, medical device companies were scrambling to meet the European Union’s new Medical Device Regulations (MDR), slated for adoption on May 26, 2020. As COVID-19 began to take hold of the world in March 2020, the Trade Association MedTech Europe came forward calling EU institutions to postpone the implementation in order to facilitate the fight against the pandemic. In response, the EU legislator adopted a proposal to delay the application of many sections of the MDR by one year. While this news may have come as a relief to many companies already facing the mounting challenges of adoption, the upcoming process will be taxing regardless of the timeline — that is — unless proactive measures are taken in the interim to plan for the eventual implementation.
Beginning the Planning Process Now
Much like the FDA’s Unique Device Identification (UDI), MDR guidelines require all medical devices to undergo a conformity assessment to receive a CE mark demonstrating all legal requirements are met. Although clinical evidence is not a new requirement to support CEs, the content and acceptability are changing under the MDR. In addition to the clinical evaluation reports, a public summary of safety and clinical performance are required for certain types and classes of devices. As the framework is less focused on the preapproval stage and race to market, MDR requires medical device companies to elevate their responsibilities for their products across the entire product life cycle. As such, this involves an in-depth audit of the CE documentation where specific devices with higher risk require high-quality data.
Determining Where to Start
While there is no one-size-fits all approach to clinical evidence, there are some good places to start. For products with high risk factors, clinical investigation is the highest-quality way to gather data. This often includes:
- A systemic literature review investigating current devices to identify what risks and performance endpoints may need to be considered
- A clinical development plan that outlines what data sources are available to determine when updates will be made
- A clinical investigation plan relating to the study protocol for your device to determine what information is needed.
Another high-quality way to gather evidence is by examining equivalence data. However, the devices must be of clinical, technical, and biological equivalence, and there are many specifications to consider if the types and classes are the same. Lastly, in some instances, case reports may be utilized for devices with less risk and more practical use as well as preclinical testing and end-user testing.
Considering the Right Clinical Study Design
As MDR focuses on increased risk management, there are increased requirements surrounding the design justification. This is based on the evaluation of the preclinical data and the results of a clinical evaluation. Additionally, a positive risk evaluation is required when the potential risk outweighs the potential benefit. Additional study design considerations include:
- Risk profile to human subjects to determine device behavior
- Selection of investigational sites with access to key opinion leaders
- Manufacturing-partner portfolios and culture to find the best fit
- Geography as it relates to the uniform approach expected
- Interaction strategies with investors to meet milestones while ensuring patient safety
- Broad analysis of competitors to determine what to expect
- External factors such as public health risks including COVID-19
Identifying When You’re Ready
As the implementation of the EU MDR has already proven to be a complex and challenging process, it is important to understand if a plan is going in the right direction. From a clinical perspective, there are several steps that need to happen before your project can move from clinical study toward market access.
Partnering with a full-service contract research organization with expertise in navigating the global regulatory landscape and a deep specialization in medical writing required will aide throughout the planning process. This will not only ensure your medical device complies at every stage of its life cycle, but that you maintain your CE mark in market.
Avania is an integrated global, full-service CRO with specialized expertise in medical device, novel technology, and combination products. They advance products from feasibility all the way through post-approval trials in analytics, clinical trials, consulting, regulatory, reimbursement, and more. To learn more, visit: avaniaclinical.com
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