In the waves of MDR – has the medtech industry drowned in documentation?
In 2017, the well-known EU regulation on medical devices, or MDR (Medical Device Regulation) as it is more commonly called, was published within medtech. A set of rules that was set up to gain greater control over the safety and performance of products used in healthcare. But the regulation came with a three-year transition period, and did not enter into force until May 2021. And that with emphasis.
The new regulation means that medical devices must be CE marked to ensure market access within the EU. The regulation affects all existing medical technology products on the market as well as the products that are in the development phase. In other words – the whole medtech industry.
Seeing the need and realizing the benefits is easy: it is basically about patient safety. However, for many companies, adjusting their processes to comply with the regulation is all the more difficult. In practical terms, this has meant for medtech companies a longer distance from production to an EU-approved product – a distance lined with documentation, requirements, and cumbersome project management. An overall more time-consuming process than before, which requires large resources from companies.
Product development under strict regulations can, to say the least, be both time-consuming and devastating for efficiency – in general. But another aspect of the problem, which is probably bigger than many realize, is the systems used for the cumbersome processes. In fact, it is often the systems themselves that make them cumbersome, with their limited uses and difficult-to-operate interfaces.
The Polarion tool is our solution for streamlining process management and development. Today, it is used in several major industry areas. As experts in methodology in product development and process management, we have assisted many companies in medtech, and in the aftermath of MDR we have seen how the tool has the potential to make real use for the entire medtech industry.
In Polarion, we have developed a template specifically to be able to validate Polarion according to FDA Title 21 CFR Part 11, the rules that the FDA sets for handling electronic registers and electronic signatures.
We have a great understanding of medtech’s industry-specific challenges in general, and we are aware of the importance of processes that are fast, predictable and above all, efficient over time. With Polarion, we can help medical devices enter the EU market – despite, or rather hand in hand with, MDR.
Do you work for a company within medtech that needs to streamline product development and project management processes? Contact us today for an introduction!