Is Your Documentation Compliant With EU Medical Device Regulations?
On May 25, 2017, the European Union Medical Device Regulation (EU MDR) came into force, marking a key point of transformation for the medical device industry.
This new set of regulations put additional responsibility on global device makers, obliging them to comply with a greater amount of regulatory scrutiny and many other stipulations. Already-approved medical devices were given a transition time of three years to meet the new MDR requirements.
From compliance officers to medical researchers to documentation managers, a range of industry professionals have been tasked with meeting these requirements by May 26, 2020.
The EU MDR is a new set of regulations that govern the production and distribution of medical devices in Europe. Any medical device company that wants to sell their products in the European marketplace must comply with them.
The regulations are set to impact a variety of processes related to medical devices. One notable impact is that companies will be required to increase the volume of documentation they produce and manage, as well as the frequency with which they do so.
The official 175-page document outlines more than 40 specific conditions for the creation, maintenance and substance of technical documentation.
Below, we address the four main criteria that medical device companies must meet in order to make their documentation MDR-compliant.
Since technical documentation is often abundant, spread across different locations, and created by multiple teams, complying with these regulations can be a daunting challenge.
To help solve this challenge, we'll also share how Zoomin enables organizations to satisfy MDR criteria while enabling the creation, management and translation of their ever-expanding documentation libraries.
MDR Annex I (23.1): Information accompanying medical devices shall be made available and kept up to date on the manufacturer’s website.
Typically, as an organization grows, so too do the volume, complexity and logistics of its documentation. Without comprehensive publishing and orchestration, content can easily become mismanaged in its distribution or maintenance.
Zoomin ingests all your documentation, regardless of your authoring tool or format, and surfaces it intuitively through your website, products, community and CRM. In addition to facilitating MDR compliance, this ensures that people find the answers they need, when and where they need them.
MDR Annex 38 (3): Documentation shall be updated whenever relevant changes occur, in order to monitor and verify continuous compliance with all the requirements.
In other words, companies must update their documentation promptly and comprehensively throughout the entire lifetime of a device.
To streamline the process for keeping content consistent and up to date, Zoomin immediately reflects any changes or updates made to your documentation – no matter where the changes were made, what authoring tool or format was used, and where the documentation is being delivered. Furthermore, Zoomin allows users to instantly access multiple versions of the same topic (for example, if they need to access documentation for a different version of a product.)
MDR Annex II: Technical documentation shall be presented in a clear, organised, readily searchable and unambiguous manner.
This is a rather ambiguous requirement, since there are varying standards of content being "organized" and "searchable". However, there is a large gap between simple search engines and elastic search engines that employ intelligent features such as weighted search, and dynamic filtering.
Zoomin provides powerful search across all your documentation – no matter the source – so people can easily find the answers they need, and can also optimize content for SEO so it shows up at the top of search results.
MDR Article 10 (11): All accompanying information shall be made available in the official Union languages(s) of the Member State in which the device is distributed.
This means that organizations will need to provide online, searchable and up-to-date documentation in up to 24 languages. This not only requires significant translation resources, but also an effective solution to integrate and publish the various localized versions.
With Zoomin, you can publish content seamlessly in multiple languages and get powerful localization analytics. Documentation language is automatically matched to the viewer, and viewers can instantly switch between languages in your portal.
There are large gains to be made by forward-thinking companies who transition to a dynamic publishing platform. By providing a unified and up-to-date place for documentation, they can dramatically reduce content costs and turnaround, improve customer self-service and support, and ensure MDR compliance.
According to Marc Miller, Division President of TransPerfect Medical Device Solutions, “Faced with substantially increased content volumes due to MDR and IVDR, structured content and automation technologies are emerging as the key components for an effective compliance strategy.”
By ingesting structured content from any source and making it dynamically available to customers, Zoomin provides an efficient and effective way to meet new regulations while freeing up precious IT resources. The platform offers enterprise-grade security, along with flexible permission models that ensure people can only access what they're entitled to see.
If you're a medical device manufacturer, distributor or importer, talk to a product expert today to learn how Zoomin can help you comply with EU MDR documentation regulations.
Note: some of the above EU MDR excerpts have been edited for clarity and concision.
