Within the next four years, over 500,000 medical devices will undergo a recertification process to better adhere to the European Union’s Medical Device Regulation (MDR) 2017/745. It sounds simple enough, but this isn’t just a simple renewal of their already-established status: the regulations have changed as the EU has placed a greater emphasis on safety and efficacy.
Man-hours and capital will have to be expended in order to ensure that the devices are both safe and efficacious, and the clock is ticking – 1200 days may seem like a long time on paper, but the data needed to satisfy these requirements is often generated at a glacial pace. Yet opportunities abound for those not content to simply meet the bar and choose, instead, to surpass it. The MDR recertification process presents a chance for medical device manufacturers to expand and diversify their customer bases and can be a transformative moment for the industry.
Alongside GCP-Service and Gouya Insights, our partners in the MedTech Alliance, we’ve written a new white paper, “Ensuring MDR Compliance: Looming Challenges in the EU for Medical Device Manufacturers,” that outlines the difficulties that Life Sciences companies with a presence in that sector and this market will face, and how to meet and overcome them with support.
This nineteen-page paper outlines how the regulations have changed, covering where they’ve been tightened, where added surveillance has been implemented, and where access and coverage for specific groups have been expanded. We’ve identified major problems that companies will run into throughout this process – namely, the altered criteria for the General Safety and Reporting Requirements (GSPR), the delayed timeline, and the shortage of notified bodies to perform their key role in recertification – that companies like the ones in the MedTech Alliance can help solve.
From ensuring that qualified subject-matter experts and linguists work on updating your documentation to providing support for both real-world data gathering and conducting clinical trials, this paper poses a key question, as well as its answer, to medical device manufacturers stressing over deadlines and the minutiae of these regulations: What if MDR recertification didn’t have to be this difficult? We answer that it doesn’t.
To read the paper, click here. To learn more about MedTech Alliance and how it may help you get your medical devices certified/re-certified in the EU, please send an inquiry to medalliance@csoftintl.com.