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.
What are EU MDR and IVDR and why are they important?
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.
EU Medical Devices Regulation (MDR)
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.
In Vitro Diagnostic Regulation (IVDR)
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.
- Software as a medical service: The earlier guidelines of the MDD were laid down way before ‘software as a medical service’ came into existence. Today, where there are a lot of devices to monitor health and apps that let you keep a track of your blood pressure, heart rate, and more, it is very necessary to set a standard guideline for their functioning.
- The lack of transparency: The MDD guidelines didn’t make the transparency of technical information of medical devices a necessity. So, the general public did not have access to clear information about the devices being used to treat them.
- Standardization of devices: The two guidelines allow standardization of medical devices and in-vitro devices across Europe and encourage compliance at a much wider level. The guidelines focus on providing an easier understanding of the medical devices and in-vitro devices in use to the public.
- Safety of high risk devices: The MDR emphasizes the specifications of high-risk medical devices to ensure safety of the devices and enhance their performance. This will also bring consistency to these devices’ results.
- Better governance: With proper coordination and governance to the system, the EU can now make provisions for the administration of scientific and technical systems.
The new labeling and artwork requirements
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:
- UDI (Unique Device Identification) for identification of medical devices in the supply chain.
- Product’s name and serial number.
- Package content and purpose of the device.
- Details of the manufacturer (non-EU manufacturers must mention their representatives)
- Storage and handling instructions.
- The time limit for safe device usage and date of manufacture.
- Indication if a product is single-use.
- Other precautions to be taken by the user and warnings.
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:
- Detailed information about the purpose of the device and the performance characteristics of the product.
- The clinical benefits along with any side effects or residual risks.
- Information on the handling of sterile devices or instructions for sterilization in cases of non-sterile devices.
- Radiation information and any special requirements for it.
- Information about the disinfection and cleaning process.
- Hazards of reusing the device in the case of single-use devices.
- Information about the disposal procedure for the devices and/or their accessories.
What should you do to be compliant?
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. Implementing label design software can facilitate these changes, ensuring that your labels adhere to the required standards and guidelines.
Here’s how businesses can prepare themselves to become compliant:
- Start with a gap analysis: Analyze where your existing procedure stands with the new regulations. Studying this gap can help you fill it up strategically with a robust plan.
- Prepare a list of compliance guidelines to be followed: List the regulations applicable to your product labels and see what new changes are to be made in each category. This will help you come up with a strong plan to include the new information according to the regulations into your existing labels and IFUs.
- Systematize the approval and feedback process into steps: Making the labeling changes requires the contribution of your design, legal, and medical teams. So, it is important to set up a step-by-step process for approval and divide responsibilities for better accountability and tracking.
How can Artwork Flow help you stay compliant with the new guidelines?
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!