A new set of regulations from the European Union covering medical devices requires organizations working in this sector to ensure their employees fully understand the new EU MDR’s requirements.
This is the major reason why medical device manufacturers need to quickly implement a MDR compliance program. Failure to comply with the new regulations is not an option. As such, here are a few tips for crafting an EU MDR compliance program. Use this advice to ensure your company follows a structured approach towards a successful implementation. Remember, if your organization sells medical devices in Europe, following the MDR is a requirement.
The Reasons Behind the New EU MDR
The EU developed the new MDR to update increasingly obsolete industry standards that are decades old. Their goals for the new regulation are numerous, including consistent health and safety for European citizens, free trade for medical devices throughout the EU, and taking into account the significant scientific progress of the last 20 years. The MDR went in force in 2017 and all medical devices sold in Europe need to comply with its regulations by 2025.
The new MDR boasts a significantly higher number of rules and regulations that must be followed. For example, new requirements place the onus on manufacturers to collect and maintain more detailed clinical evidence generated during medical device trials.
Planning is Essential for an EU MDR Compliance Program
Like any other large project, significant planning is vital for a successful EU MDR compliance program. Determining the overall scope of the effort is an essential part of this planning process. Additionally, a detailed GAP assessment is another important requirement, including both the manufacturing and clinical trial elements of your company’s operations.
Once the individual portions of the compliance program are determined, formulate a schedule that ensures any time-critical tasks are completed first.
Analyze Existing Device Portfolio
Analyze the company’s medical devices currently in the EU market. Is retrofitting them to meet the new MDR cost-effective, or are new designs required? Determining your ultimate ROI is an essential part of answering this question. Of course, your company’s presence in the European market compared to the rest of the world factors into this analysis.
All this information feeds into a master compliance roadmap for your company’s EU MDR efforts. Supply chain considerations, regulatory training for your employees, and verifying the effectiveness of the compliance plan are also essential.
Ultimately, this article only touches the surface of a very complex undertaking, but one that’s vital for any medical device manufacturer hoping to thrive in the EU over the next few decades.
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