For a few decades, the European Union Medical Device Directive (EU MDD) regulated much of Europe’s production and distribution of medical devices. But now, the EU Medical Device Regulation (EU MDR) has taken over, improving Europe’s medical devices for the patients who use them. The MDR is much more comprehensive and specific than the outgoing MDD, with many differences.
The U.S. is Europe’s top supplier of medical devices. Manufacturers selling devices in the EU, even if they are manufactured in the states, must comply with the rules and regulations in the MDR. The full transition to the MDR will be a yearslong process, and there are even extended transition deadlines for American organizations which meet certain conditions.
But as a U.S. manufacturer, even if you have time to comply, you shouldn’t wait. Instead, you should fully comply with the MDR as quickly as possible. Because if you lag behind, you’ll face additional compliance costs; your products will be delayed to market, and you’ll lose significant revenue. Do you have the ability to quickly comply? More specifically, do you have the expert staff in place to understand the regulations, and put policies in place to comply with them?
Comply with the EU MDR by finding expert staff.
To adhere to the rules outlined in the EU MDR, you must have staff members who can do three specific things:
- Understand the intricacies and nuances of the new rules.
- Put internal policies in place to ensure compliance.
- Effectively implement the policies across your organization.
You should look for talent who are intimately familiar with the various rules and regulations in the EU MDR. You should also seek significant compliance experience in the medical device space, or at least in the broader life sciences industry, regardless of the governing body or set of regulations. Oftentimes, that experience can seamlessly translate to EU MDR compliance.
As for soft skills, it’s important to hire contract or permanent talent with a high attention to detail, simply because of the painstaking analysis and remediation activities that may be required for compliance. The ability to be organized and manage a project with very particular details and timelines is also key. Lastly, considering the high-level of detail and organization needed, prioritize strong communication skills, which can help to eliminate gray areas on project teams, and express the risks and rewards associated with compliance across your entire organization.
Partner with Medix to find expert staff, comply, and maintain revenue.
Here at Medix, we specialize in medical device staffing. We understand the entire lifecycle, from conception to R&D to commercialization (and compliance), and the rigorous work that goes into it. Our deep understanding, along with years of building relationships with clients and candidates, has allowed us to create a deep network of not only compliance professionals, but also assemblers, engineers, managers, and technicians.
While you shouldn’t wait to find expert staff to help your organization comply with the EU MDR, you also shouldn’t take any chances. To hire the professionals you need, partner with us. You will:
- Enable your internal HR and recruiting teams to focus on other responsibilities, and avoid burnout related to EU MDR recruiting.
- Reduce increasingly expensive recruiting costs related to advertising, screening, interviewing, and onboarding hard-to-find candidates.
- Quickly and cost-effectively get the specific talent you need for your organization’s EU MDR compliance efforts.
- Ensure compliance with the new regulations, and, in turn, keep your European market share and revenue.
The worst thing you can do is wait to become compliant with the EU MDR. Prioritize it today to beat your competition, and maintain your European revenue. Contact our experts now.
