You will never believe it but the labels are an integral part of your medical devices, so I wanted to help you understand labels and how to implement them on your systems.
I had made a presentation during the Greenlight Guru event and wanted to answer the questions received, So below you can see the podcast episode with my answers
Podcast episode 120 - Create a Label Q&A
Table of Contents
How to create a Label per EU MDR 2017/745?
The first thing to say is that the label content depends on the region where you are selling your products. So here we will focus on the European Union.
According to the definitions in the European Union’s Medical Device Regulation (MDR) (Article 2)
“label” means any written, printed, or graphic information appearing either on the device itself or on the packaging of each unit or on the packaging of multiple devices.
The purpose of the labeling process is to identify a medical device and its manufacturer and to communicate essential information on safety, use, and performance.
It is intended for users of medical devices, both professionals and consumers, and for relevant third parties.
Here you may understand that this label is really important as it provides information that is critical for the users or patients. This is why there is a regulation telling exactly what should appear on it.
Labeling requirements under the new MDR
Compared to the MDD 93/42/EEC, there is a need for much more information on the labels under the EU MDR 2017/745, because device safety and clinical effectiveness data are required to be shared transparently with users (both medical staff and patients/end users).
All requirements regarding the information supplied with the medical devices are covered in Chapter III of Annex I, General safety and performance requirements, in the EU MDR.
There are two possible problems when trying to comply with the EU MDR labeling requirements.
- One is to be sure that all necessary symbols and information are covered.
- The other is the size of the label.
As there will be many more symbols and data required, the big challenge will be how to fit it all on the label.
During label design, keep the following in mind: the medium, format, content, legibility, and location of the label and instructions must match up with the technical knowledge, experience, education, or training of the intended user(s).
Furthermore, instructions for use must be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams.
It is also good to know that you have a choice in format(We provide some examples at the end of the article). Labels can be provided in a human-readable format and should be supplemented by machine-readable information for example for UDI. Check UDI Article.
Symbol vs no Symbol
Let’s imagine what would be your experience with and without symbols. This is I am sure very convincing.
So we start first with this image without symbol:
So, you should understand that 1 symbol can avoid you to translate the information in all languages. Here we have only 3 languages but imagine that you also sell this product in Greece, Spain, Italy, the Netherlands.
Now let’s see the same label with symbols. I am sure you will see this as a more convenient solution.
New revision of ISO 15223-1
As seen before, one of the tools that are used to create labels is symbols. These are really important as 1 symbol can replace a sentence and then can avoid you having to translate words in all the different languages. So you can create your own symbols but what is recommended is to use international standards like ISO 15223-1.
There is a new revision of the standard:
ISO/DIS 15223-1:2020 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.
There are completely new symbols that cover the new MDR requirements.
If you want to know more about new symbols, you can acquire the ISO standard and also check this guidance from Medtech Europe.
One thing that you still have to do is to describe those symbols inside your instruction for use. So don’t forget that.
How to be prepared?
Achieving compliance with the MDR will naturally create labeling challenges for medical device manufacturers.
Companies need to ensure that their current labeling system is fit for purpose. Therefore, the best way to prepare your MDR labels is to go through Annex I General safety and performance requirements, Chapter III, requirements 23.2 and 23.3, and to find out which of these requirements is applicable for your medical device.
After you define that, you need to create the design of your label using symbols from ISO 15223-1:2020. Nevertheless, keep in mind that this design has to be flexible, because regulations are often changing, and you need to be able to respond to those changes very quickly.
When do medical device manufactures have to meet the new EU Medical Device Regulation?
Originally, there was a transition period of 3 years for the implementation of the new EU Medical Device Regulation.
Accordingly, most of the articles of the regulation should be enforces from May 26, 2020. Due to the COVID-19 pandemic, the enforcement was postponed by one year. The new deadline is therefore May 26 2021.
But mainly, class I devices should update their labels immediately from May 26th, 2021 unless they still benefit from a transition period (Software or Reusable Surgical Instruments).
And the products that are still under MDD can continue with their label and will need to change as soon as they transition to MDR.
Innovations by MDR 2017/745
Manufacturers of medical devices are subject to a number of new requirements as a result of the EU Medical Device Directive, mainly the following:
- The scope of application also extends to non-medical products (e.g. contact lenses, devices for liposuction).
- Each medical device must bear a unique identification number (UDI).
- Manufacturers must register themselves and their products via the Europe-wide EUDAMED database and submit their data.
- Higher requirements are placed on technical documentation, especially in connection with the required risk management.
- Clinical trials and evaluations are being tightened and products are being monitored even after their market launch.
- Responsible persons who have qualified expertise on the manufacturing of medical devices must be appointed.
- For high-risk medical devices, an additional control procedure (called ‘scrutiny procedure’) for conformity assessment by a panel of experts is planned.
- Notified bodies are more strictly regulated, so that a renewed selection and inspection may be necessary.
What are the new elements on the labels?
You may ask yourself what has changed. So here we go through some of the points.
One of the main changes is the fact that you have to mention on your label that your product is a Medical Device.
You can write it. But if you are selling your products in many countries then you’ll need to translate each of the mentions into different languages. Or you can use the MD symbol made for it.
The other element that changes is the inclusion of the UDI code. You may still have some time before to place it on the product but you can put it as of today if your product is compliant to EU MDR. Look at this article on UDI.
For some special devices, you should also clarify their status, If the device is intended for clinical investigation only, then the labels must contain the words “exclusively for clinical investigation. Same if the device is “Custom made”.
One new element is also the mention of CMR if your product contains more than 0.01% w/w CMR substance.
Below you’ll see the list of requirements coming from Annex I chapter III.
Medical Devices Labeling Checklist for EU MDR Compliance:
Manufacturers must conduct the labeling criteria with utmost priority and caution as the EU MDR transition deadline approaches and must maintain high levels of quality and safety for enforcement.
Prior to implementation, it is important to consider the current labeling standards and ensure that they are correctly implemented.
Any labeling errors may lead to Product Recalls and trigger costly affairs for the manufacturer.
This is why I have said at the beginning that the Label is part of your device. Because an error on it is like an error on the device. And I have already recalled some products because the expiration date was wrong on the label for example. Don’t take this too easy.
As a result, it is important to carefully plan medical product labels that comply with EU MDR labeling criteria, such as:
Medical Device Labeling Requirements as per EU MDR:
- If there is no expiration date, manufacturers should include the device’s name and trade name, as well as the manufacturing date.
- A Standardized Symbol/Logo/ ICON must appear on all labels of the Product, indicating that the product being delivered into the Europe Union includes a medical device.
- The label must provide all the information needed for a customer to recognize the packaging’s contents and intended use.
- If a medical device manufacturer is located outside of the EU, the approved licensed EU representative details should be prominently displayed on the label.
- The time limit should be expressed on the label in terms of the year and month for safely using or implanting the product.
- The Medical Device label must be listed with the warnings, instructions, precautions, or contradictions that need to be brought to the immediate attention of the user, while in use.
- The Unique Device Identification (UDI) carrier should be present on the each label. Unique identifying “part numbers” issued by a neutral party and allocated to finished products, product packaging with UDI logo, UDI on the product itself (direct part marking) for certain products, and UDIs must be registered in the EUDAMED database are all necessary components of a UDI.
- Web address along with the eIFU (electronic Instructions for Use).
- Device Identifier (DI) and Production Identifier (PI) must be included in the UDI symbol’s composition (PI).
- Machine-readable information can be added to the labels, which must be given in a human-readable format.
- For devices with absorbent materials, the labels must provide overall composition in addition to quantitative details on the key constituent(s).
- Product name
- Product’s lot number or serial number
- All details needed for a user to identify the device, the contents of its packaging and the intended purpose of the device.
- Contact details of the manufacturer (e.g., name and address)
- In the case of non-EU based manufacturers, the name and address of their authorised representative
- Where relevant, information per Section 10.4.5. of the MDR
- The UDI carrier referred to in Part C of Annex VII of the MDR
- An indication of any special storage or handling conditions
- A clear indication of the time limit for using the device safely, or where this is not applicable – the date of manufacture
- If the product is supplied in a sterile condition, an indication of its sterile state and method of sterilisation
- An indication if the product is for single-use
- An indication if the device is custom-made or intended for clinical investigation only
- Other warnings and precautions to be taken that need to be brought to the user’s immediate attention.
- Finally, recognizing and enforcing the above EU MDR labelling criteria is the most difficult part of making your medical device label EU MDR Compliant. Failure to follow proper protocols would result in needless Regulatory enforcement issues and expensive product recalls. As a result, manufacturers must be aware of the latest MDR labelling standards in the EU. What is the effectiveness of your device labels? Are they in line with the specifications? For a straightforward assessment, contact a Regulatory Device Labelling specialist. Keep yourself up to date. Maintain your composure.
Legal Manufacturer or only Manufacturer
The label is the place to go to understand the status of a device. For example, when you want to understand who is the Legal Manufacturer of a device. And this doesn’t specifically mean that this company his having a manufacturing process, but this means that this company is taking the responsibility of this product in the European Market.
We have this confusion when we talk about Own Brand Labelling (OBL) or Original Equipment Manufacturer (OEM). This economic model is not authorized anymore by the EU MDR. You can still ask someone to manufacture a product for you but they will be considered as suppliers and not Legal Manufacturers.
Now, you have to choose your status. If you are the legal manufacturer of the product then you need to have your name behind the Black Plant Symbol.
For example, you are located in the Netherlands, and your product is produced in China. But you want to be the legal manufacturer of this product. Then you have to mention your name only behind the Black Plant Symbol.
If you want to follow Article 16 of the EU MDR, where you are willing that your Supplier is the legal manufacturer but that they use your trademark, then the supplier will have to place his name behind the Black Plant Symbol. Your name will be placed behind the Importer or Distributor Symbol.
Below I wanted to show you the different levels of Labelling and packaging. You can have multiple labels on different levels of your products. So this is really important that you understand at which level you are.
Levels of label
The primary or prime label is generally placed in a prominent position on the top or front of a product. It is usually decorative and eye-catching and includes only the most important pieces of information about the product.
This may include the product name, contents, company name, a slogan or tagline, logo, and brand colors.
The primary label should grab a potential customer’s attention and convey the brand identity of the product.
If your primary label is too small to contain all the details, it is authorized if justified to then transfer some information to the secondary label.
For example, if the UDI cannot be placed on the primary label, then we transfer it on the secondary label.
A secondary label is generally placed in a less prominent position at the bottom, back, or side of a product.
A secondary label contains information about the product such as its ingredients and nutritional values, health and safety warnings, instructions for use, manufacturer or supplier details, contact information, or detailed tracking and product information in a barcode format.
This label should contain information that is specific to a particular product; this may be specific to a product line, an individual product, or bespoke products that have information that is unique to a single item.
A secondary label should provide potential customers with more detailed information about the product they are considering purchasing.
Levels of packaging
Primary packaging is the packaging in direct contact with the product itself and is sometimes referred to as consumer or retail packaging. The main purpose of primary packaging is to protect and/or preserve, contain, and inform the consumer.
Secondary packaging’s main purpose is for branding display and logistical purposes. As well as protecting and collating individual units during storage and are often used by the beverage, food and cosmetic sectors for displaying primary packs on shelves and are sometimes also referred to as grouped or display packaging. Secondary packaging also includes packaging purposely made to display multiple product units for sale which speeds restocking from storeroom to shelf, this packaging includes retail-ready packaging (RRP), shelf-ready packaging (SRP) or counter-top display units (CDUs).
Tertiary packaging facilitates the protection, handling, and transportation of a series of sales units or secondary packaging in order to group everything into unit loads during transit. This type of packaging is rarely seen by the consumer.
Example of Primary, Secondary & Tertiary Packaging
I hope that you understand now that the product label is critical for your medical device. Without it, there can be some issues as users or patients will not understand its content or its purpose. So having this information on it is critical to the success of your product.
If you need someone to create or review your label, don’t hesitate to contact me so I can help you.
Label Template Examples: