The Medical Device Directives (MDD), implemented in 1992, don’t work well with how the present medical device industry is progressing. Owing to the newer solutions the medical industry has come up with in the form of devices, test kits, and even mobile applications, the regulations called for a major update.
The European Union decided to give this update to the regulations in the form of the Medical Devices Regulation (MDR) and In Vitro Devices Regulation (IVDR). Implementing these regulations will not only make monitoring of the production and distribution of medical devices more standardized but also transparent.
The introduction of these regulations has posed some challenges for medical device manufacturers in the form of compliance in labeling and artworks. There is a need for a robust system that can help them stick to the guidelines and stay compliant with the latest rules.
So, in this article, we’ll discuss what changes these two new regulations have brought to the labeling requirements and how you can comply with them.
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The European Union’s medical devices industry saw a major change in the regulatory environment in about 20 years in the form of Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). These two regulations were introduced to replace the existing Medical Device Directives (MDD) as the older directive did not include the recent developments in the field of medical devices.
So, let’s look at just what these two regulations are about.
The Medical Devices Regulations govern the production and distribution of medical devices in the European Union. The 27 member countries have to follow these regulations to sell their products in the European economic area.
The new MDR is focused on the life-cycle approach to the regulation of devices rather than a pre-launch stage approval. The aim is to make the manufacturers more responsible for their products throughout their life cycle.
The In Vitro Diagnostic Regulations are to regulate the in-vitro medical devices like SARS-CoV-2 tests, HIV tests, and more. The introduction of this regulation was important because of the large number of clinical decisions taken on the basis of its results.
IVDR is introduced to ensure better protection of public health by keeping a check on the manufacturers of these in-vitro devices. The regulations also include in-house devices that are manufactured by health institutions.
Now that we have a general idea of the EU MDR and IVDR, let’s understand why these regulations are important.
The EU MDR and IVDR have also introduced some changes in the labeling and artwork requirements for medical devices.
Here are some of the new labeling rules you need to comply with as a medical device manufacturer:
The MDR and IVDR also include guidelines for user manuals and Instructions For Use (IFU) of medical devices.
Here’s what the IFU must now include:
To comply with the latest guidelines of the MDR and IVDR, your brand needs to take some solid steps. Both your quality-checking process and label proofing methods will see some significant change to make your brand compliant.
Here’s how businesses can prepare themselves to become compliant:
Along with the labeling and artwork changes, you also need to take care of various other operational changes in the manufacturing and distribution process to stay compliant. At this point, having an artwork management platform that can handle all labeling compliances with its smart tools and features can be a boon. It can make the compliance process simpler and systematic.
With features like comparison, version control, and efficient proofing, these tools allow your brand to stay compliant while maintaining creativity and consistency of brand voice. One such tool is Artwork Flow which provides all these features and more. It will also help you align and speed up your approval process in addition to adhering with all rules and regulations.
Here’s how Artwork Flow can be beneficial for your medical device brand:
While the MDR and IVDR have brought about many changes in favor of end users and the general public, medical device manufacturers have to go through major changes in labeling and quality management. You need to make sure your products and devices are compliant with the latest guidelines to avoid legal action, fines, or costly product recalls.
And this can be done only when you have a strong system that can handle all the labeling and IFUs at one place and streamline the approval process to make it faster and more accurate.
Artwork Flow has all these features and much more to help your medical device brand stay compliant with MDR and IVDR. If you’d like to see first-hand how the platform can help you on your compliance journey, talk to one of our product experts today!