EU MDR 2020: Are You Ready?
Michael Roder looks at the challenges medical device manufacturers (MDMs) face in regard to the new regulations and how they can ensure they are able to access the specialist expertise they need.
By Michael Roder, Director, Global Solutions, KellyOCG
From May 2020, the EU Medical Device Regulations will fully apply. This means that medical device manufacturers will soon be faced with much more stringent requirements on everything from labelling to instructions for use (IFU). The changes will also see the establishment of a comprehensive EU medical device database. These new requirements will improve traceability of products, track adverse effects, and promote proper use, helping to ensure greater patient safety. These efforts to increase safety have been welcomed by patient groups, healthcare professionals, and Life Sciences organizations, but they also bring with them huge challenges. MDMs face a race against the clock to ensure compliance, and, for those who have been slow to act, it can be difficult to know where to begin.
I take a closer look at these challenges and the people solutions that can help to ensure compliance with the new regulations, below.
It’s a Tight Talent Pool
The community of medical device specialists, from technical writers to regulatory experts, is small. This, coupled with the current backdrop of regulatory change, means it can be tough for organizations to access the talent they need to prepare for May 2020. A way to overcome this pressing challenge is to partner with a talent organization that specializes in the medical device space. A tailored and well-managed Functional Service Provider (FSP) solution can help to ensure that organizations are able to plug into the steady stream of expert talent needed to support MDR requirements. The FSP model is an appealing solution for MDMs looking to retain a level of control over outsourced MDR resources while leveraging the operational support and a governance framework needed to drive quality and reduce costs for critical projects. This is a subject I explored in my previous post on choosing the right service provider for clinical trials.
Regulatory Obligations are Ongoing
Preparing for the upcoming changes is not enough. The incoming regulatory obligations are ongoing, and MDMs must look at the long-term picture when it comes to allocating resources and planning for future research and development. The creation of a dedicated center of excellence can help global organizations to build a framework that enables them to navigate the complexities of these regulatory changes through 2020 and beyond.
Specialization Can Come at a Premium
Small and highly specialized consultancies may be able to find the talent that MDMs need to prepare for EU MDR changes. However, this can be an incredibly expensive option and one that is likely to be unsustainable. Organizations may, instead, consider a fully outsourced model which can offer better value, though often at the cost of control. Ideally, a strategic talent partner will offer a blend of the benefits of both of these options, helping to drive engagement with specialized talent while ensuring full visibility over the journey to regulatory compliance.
The EU MDR changes are coming, whether your organization is ready or not. Ensure you’re prepared by choosing a talent partner that supports your business as you navigate these complex regulatory challenges.