Mark Rhys Burke, Senior Account Executive, Pilgrim Quality Solutions, an IQVIA company
In May 2017, the European Union (EU) embarked upon a three-year transition period designed to give medical device manufacturers time to comply with new regulatory requirements. The enforcement deadline for compliance with the Medical Device Regulation (EU MDR) is May 26, 2020. That deadline is looming large for everyone in the industry.
That said, I regularly speak to individuals who express trepidation about this rapidly approaching date. They simply don’t have the necessary documents and data prepared to meet the stringent new requirements – and they’re not alone. A recent survey of more than 200 regulatory and quality leaders at major medical device companies showed that 78% of those polled did not have sufficient understanding of the new regulations.
So, which camp do you fall into? Are you prepared for the implementation of EUMDR, or do these impending regulations have you more worried than you’d like to admit?
What is the MDR?
The new Medical Device Regulation (MDR) has been drafted to replace the EU’s Active Implantable Medical Devices Directive (AIMDD) and the Medical Devices Directive (MDD). With an emphasis on hard data and clinical evaluations, the MDR is meant to improve the patient experience by increasing reliability, safety, and performance.
The new requirements mandate that devices be more traceable throughout the supply chain and device lifecycle. While this is certainly not controversial, some are up in arms at the call for more clinical evidence on all devices, even those that have been on the market for decades.
You might be wondering why this legislation is being enacted at this point in time. The answer is that there has long been a lack of industry regulations within the European Union. Recent incidents such as the hip replacements and the breast implant crises drove the need to improve requirements. Though the AIMDD and the MDD were designed to address these same issues, they contain certain oversights and weaknesses that are due to rapid advancements in the technology.
These issues have led to consumer distrust and sullied the reputation of the medical device industry among healthcare workers. This new EU regulation will go a long way to assuaging potential problems in the future.
The Most Important Thing Companies Must Consider
Simply put, the most important thing you can do is plan, plan, and plan. Companies need to act quickly and ensure that they are taking all appropriate steps to understand and address MDR. This is not something that any organization should leave to the last minute – without a sensible amount of preparation, you’ll likely find yourself in deep trouble. You need a sufficient amount of time to evaluate product portfolios and gauge if the clinical data that you currently have captured will at a minimum meet, and hopefully exceed, the new requirements.
Today’s Action Plan
Here are three things that you can do today to be equipped to comply with EU MDR tomorrow:
- Start planning for EU MDR timeline – Now is the best time to start understanding the forthcoming regulations and all the ways that it could potentially impact your business. Start working on a comprehensive plan to test and assess your devices against the new EU MDR requirements.
- Review your portfolio in case you need additional data and documentation – Note, the EU MDR does not grandfather legacy devices into compliancy. This means that each and every one of your current devices needs to be thoroughly reviewed for compliance with all new requirements. The new regulation requires a lot more supporting data and documents than was needed in the past. These documents include:
- safety update reports
- post-market surveillance plans
- summaries of safety and clinical performance
- regular post-market clinical follow-up reports
More emphasis will now be placed on clinical evaluation requirements, so you will be required to collect and maintain the necessary clinical data. Finally, you need to remember that certain devices that you use or sell might need to be reclassified. This will involve collecting additional data and documentation — processes that will cost you valuable time and resources.
- Undergo a ‘technology landscape assessment’ – This is the best time to start evaluating your organization’s regulatory, clinical, and quality systems. Your systems should all improve your MDR compliance, increase your transparency, and reduce the risk of falling afoul of the new regulations.
You Don’t Have to Go It Alone
Confused? Worried? IQVIA is here to help you navigate all the new requirements of the EU MDR. The IQVIA MedTech Regulatory team is comprised of top industry professionals and former FDA officials, all working together so that your business remains ahead of the game. By using smart solutions highly tailored for our industry, IQVIA will ensure that you’ll sail through the complexities of this transition.
Planning for the New European Regulatory Environment
This brochure from IQVIA outlines the key elements to both the Medical Device and IVD Regulations, and more.