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. You must be able to comply properly, meaning it’s time to take advantage of the EU MDR regulations through electronic distribution.
What these new regulations allow you to do is make changes to your environment and make it easier to lower print cost, which benefits your consumers. To comply, start by following these steps below so you can give others better access to instructions-for-use (IFUs):
Better Customer Experience
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 can help you create a single point of access for all IFUs to integrate into your website.
The latest technology streamlines various workflows in your organization, while digital solutions allow you to accept print requests from your customers and suppliers as you track medical devices through your supply chains, for example.
The patient cares about the safety of the equipment being used on them, but doctors and medical technicians are the most common users of medical devices. By giving them access to our solution, they will be able to easily access IFUs and ensure the safety of their patients.
Reduce Print Costs
EU MDR allows manufacturers to make electronic versions of IFUS for some devices (specifically Class III implantable devices) available, eliminating the need for print. This way, customers will now have a second portal that provides electronic delivery of patient implant cards and other documentation.
Due to their regulatory validation and approval processes, the “approved” IFUs need to remain in their Quality Management Systems where they are managed and tracked most typically. 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 IFUs. Our platform allows you to share documents and manage your distribution any way you want!
Meet Regulatory Compliance
Many organizations use several tools to store and manage the documents they need for EU compliance. Our solutions provide a platform that makes it easy to quickly evolve with regulatory needs and ensure compliance.
Your team needs quick access to IFUs so you can provide patients and practitioners with up-to-date instructions they need. With Mimeo, you won’t have to rely on several pieces of software for this kind of access. Digital tools for EU MDR compliance like Mimeo will manage the efficient delivery of the approved IFUs when they are ready to share.
Follow the 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.