The European Medical Device Regulation (MDR) went into effect on May 25th, 2017, and manufacturers have until May 26th, 2020 to align existing devices with these regulations. For these manufacturers, thinking about this impending “due date” is cause for concern. Ensuring everything is constructed according to regulatory standards is daunting and complicated, especially in a business where profuse governance is commonplace.
Why is it Complicated?
Conventionally, the teams involved in the lifecycle of a product operate independently of one another.
The Traditional System:
- Engineering Team: Design → Manufacture → Service
- Regulatory Team: Submit design to EMA for approval → Receive approval
- Quality Team: Recognize product errors → Correct errors
The breakdown of the three systems, in part, happens because of how each team engages with the design of the product.
The engineering team is responsible for the design, manufacturing, and service of the product. They rely on Computer-Aided Design (CAD) files to complete each phase. These files are remarkably detailed and include even the most mundane specs.
On a different track is the regulatory team which is responsible for achieving approval for the devices through the European Medicines Agency (EMA). To do this, they reference 2-Dimensional printouts for information on the design of the product. Here lies the first dilemma: The regulatory team and engineering team use different mechanisms to reference the same product’s design.
Adding insult to injury, the engineering team often makes changes to the design while the original model is awaiting approval. Consequently, the product that reaches the market is different than the one that was approved.
On the third track is the quality team. They perform Corrective Action Preventive Action (CAPA) on non-conformant or non-compliant products. Measures are taken to ensure the same problems don’t arise again. To do this, the team references a parts list of the product in question.
Without a system which can aggregate data from all teams, time to market increases, the quality of products decreases, and compliance issues run rampant.
It’s apparent that having three separate systems to produce one product is counterintuitive, so there must be a solution.
What is the Solution?
It’s crucial to remove the invisible wall between teams. Instead of having MANY systems, have A system. PLM software provides an efficient mechanism to accomplish this goal. An effective PLM system has the power to integrate data across all teams within a company throughout all stages of the manufacturing process. This reduces the time to market, increases the quality of a product, and ensures compliance.
Instead of an array of systems which do not align, PLM enables a system where all teams can have the most up to date information on a product. Instead of three uncoordinated teams on three loops, there are three coordinated teams on one loop:
Design → EMA Approval → Manufacture → Service → Fix Issues
It comes as no surprise that categorized industry leaders are more prepared for the impending regulations than categorized followers. 86% of industry leaders say they utilize PLM to create a unified quality process. Industry leaders are also 1.4 times more likely to be compliant with EMA regulations. The correlation between the two is self-evident.
Final Thoughts:
Updating your medical devices so they comply with MDR is complicated and time-consuming. Your team has a common goal, but without a system that can aggregate information across all teams, that goal can be difficult to reach.
A system, like PLM software, can help ensure your company’s medical devices are up to the EU’s regulatory standards by May 26th, 2020.
Contact ArcherGrey to explore how your company can use PLM to navigate MDR.
