Learn how Mimeo helps with IFUs for EU MDR

EU MDR IFU

 

The European Medical Device Regulation (EU MDR) is the repeal of current regulations on medical devices, which goes into effect next year. It guarantees the highest quality and safety standards for medical devices produced and supplied in Europe. 

 

If you manufacture or distribute medical devices in Europe, then these regulations — which become fully implemented in May 2020 — might worry you. After all, if you don’t comply properly, you might not be able to make or sell your products overseas. 

 

What these new regulations demand is that instructions for use (IFUs) should now be made available for both electronic and print formats. To comply, start by following these four steps below so you don’t become trapped by EU MDR:

 

Comply With EU MDR 

 

Trying to manage EU MDR IFUs manually is a chore, and there are probably hundreds of other tasks that you need to complete. There’s good news though – our solution provides all IFUs in one place!

 

The latest tech improves EU MDR compliance and streamlines various workflows in your organization. Digital solutions allow you to accept print requests from your customers and suppliers as you track medical devices through your supply chains, for example. 

 

Digital tools for EU MDR compliance like Mimeo will manage all IFUs and distribution as products move through your sales funnels, from the warehouse to the medical office. 

 

Reduce Print Costs

 

EU MDR requires you to make IFUs available in both print and electronic format when distributing products in Europe. Our solution makes it easy for staff to distribute the documents, not access them. Otherwise, you could jeopardize compliance with EU legislation or face limitations from patients. 

 

If you want to safeguard your business for EU MDR, make sure you use a print and electronic solution like Mimeo to make it easy to provide print and electronic IFUs (e-IFUs). The Print and Digital platforms allow you to share documents and manage your distribution while following EU MDR requirements.

 

EU

 

Centralize Your Documents

 

Many organizations use several tools to store and manage the documents they need for EU compliance. This can pose a number of problems. Your team needs quick access to IFUs so you can provide patients and practitioners with the up-to-date instructions they need. 

 

Centralizing your documents with one system will improve compliance immediately. Plus, you won’t have to rely on several pieces of software. 

 

Improve Customer Experience

 

Imagine patients could access your IFUs on your website. Not only would this improve the patient experience, but it would reduce pressure on your customer service team. 

 

The latest digital tools let you embed IFUs (also called e-IFUs) on your website for quick patient reference. This can also reduce litigation from patients — point out that you include clear medical device instructions on your website. 

 

Follow the four points above and take the stress out of EU MDR IFUs. The latest technology like Mimeo makes it easy for you to adhere to EU legislation when manufacturing and supplying your medical devices in Europe.

 


Let us show you how we can improve your company’s efficiency and expenditures.

We are committed to innovation, quality, and customer service. Speak to one of our specialists to learn how Mimeo can improve ROI on your print expenditures: