The new EU Medical Device Regulation is effective since the 25th of May, which means that the Medical Device sector needs to increase its compliance level. To succeed in complying with the new MDR you need an overview of where your company and devices are currently standing. Based on your GAP analysis you can determine your strategy and start making a planning. It all starts with overview. To provide you some first aid in the lengthy process of MDR implementation we designed the EU-MDR First Aid App.
How can this app help me with a complicated project as getting in compliance with the EU MDR?
Gert Bos, one of Qserve’s Partners took part in the discussion group setting up the new European MDR. Based on this knowledge and the broad Qserve experience we are the front runner in helping manufacturers to implement the MDR. To help manufacturers worldwide with a simple tool to verify your status of the MDR implementation we created the EU-MDR First Aid App.
How can I use the app?
First you need to download the app in the app-or play store by using the search words “Qserve” or “EU- MDR”.
- To get started in the app, you need to create a profile. The profile consists of 2 parts: a personal profile and a product profile. It’s also possible to create multiple product profiles. Most companies have multiple product lines and that’s why we created the option to do the compliance check for multiple products. After you created a profile you can start with the compliance check. When you start, please check your product profile to make sure you provide answers that reflect the selected product.
- The compliance check is divided in 9 chapters. All chapters represent a part of the EU MDR. Within each chapter you will get questions you need to answer with “yes” or “no”. After completing a chapter, you see your compliance status. The status contains a graphic with your status and the market status. If you are in compliance, you will see an ‘ok mark’. When this chapter is not applicable you will see a ‘N/A’ mark and otherwise you will see a percentage. In case you are not fully in compliance (yet) you will see “next steps”. This is a brief advice what to do to reach 100%. By clicking on the “go further" button you will go into the first aid kit. The first aid kit is a step by step approach to get in compliance.
- After you have completed a few chapters, it is possible to go to the compliance dashboard. Here you will find your status per chapter. By clicking on a graphic, you can do the compliance check, update your status, or check the advice how to get in compliance.
- After completing the compliance check, it’s possible to create a report. This report contains all chapters, your outcome per product, but also all the questions you have answered. This report can be sent to a colleague, yourself but also to Qserve if you want advice or support with implementing full MDR compliance.
- The app is designed for long term use, it is possible to update your app on a regular base. We will keep updating the app with more useful practical advice.
Should you have any questions or need support with implementing the EU-MDR after you have done the compliance check, please don’t hesitate to contact us.