The term “labeling” in the European in vitro diagnostic medical device Regulation 2017/746 (EU IVDR) refers not only to a physical device label but encompasses all accompanying “written, printed or graphic information appearing either on the device itself or on the packaging of each unit or the packaging of multiple devices” as per Article 2(13). Concerning in vitro diagnostics (IVD), the requirements on labeling and Instructions for Use (IFU) are derived from Chapter III, Section 20 of the EU-IVDR. While manufacturers of IVDs selling in Europe are familiar with the requirements of the in vitro diagnostic directive (IVDD: Directive 98/79/EC); the EU IVDR’s extensive labeling requirements can be challenging to implement.
The key topics that the EU IVDR focuses on in comparison to the previous directive include:
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- Traceability: introduction of machine-readable device and production identifiers to ensure the device can be traced back to the source;
- Eco-Friendliness: implementing electronic IFUs (eIFU) have eased the requirements for paper copies accompanying the device.;
- Near-Patient Testing: formally inducted into Chapter III for testing which happens outside a traditional clinical lab;
- Respecting Users Language Proficiency: translations of the labels and IFU in the local language of the EU member state;
- Patient Protection Against Misleading Claims: requirements to align labeling with product specifications so that the claims made have valid clinical evidence and in the case of Class C and Class D IVDs, Article 29(1) requires that the Summary of Safety and Performance (SSP) is accessible via the label.; and
- Software as an IVD: keeping in line with the usage of software in recent years for diagnostics, measurements, and validation for IVDs.
Key elements of labeling IVDs under the IVDR
In this article we highlight key elements and requirements when it comes to “labeling” in vitro diagnostic medical devices under Regulation 2017/746 (EU IVDR).
Essential information for preparing IVD labels
Typical information for IVD Labels (Chapter III, Section 20.2) includes:
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- Device Name, Trade Name with Serial and Lot Number;
- Package content and Intended Purpose;
- Standardized EN ISO 15223-1 symbols to identify the device as an IVD (including self-testing or near-patient testing), risks, warnings, storage conditions, handling, sterility, single-use indication (if any);
- Identification of an Authorized European Representative and Importer as detailed in Article 13(3);
- Unique device identifier (UDI) as referred to in Article 24 and Part C of Annex VI;
- Shelf Life indicates the duration of safe usage and date of manufacture.;
- eIFU and company website link; and
- Specimen Requirements for use for self-testing IVDs (e.g., blood, urine, saliva).
Inclusion of UDI-DI and UDI-PI on IVD labels
Labels under EU IVDR regulations must have both human and machine-readable formats. These labels must be on all individual reagents and components within the kit.
While UDI compliance may initially be complex to implement, incorporating UDI information on labels which aligns with the Global Unique Device Identification Database (‘GUDID’) requirements, is essential to selling IVDs in Europe.
To comply with UDI regulations, manufacturers must incorporate both UDI-DI and UDI-PI on the device labels. Coding standards used are as per Article 24(2) of the EU IVDR. These device identifiers must be available on the Declaration of Conformity and uploaded on the EUDAMED database as well. The UDI-DI is a fixed code specific to the model of the device while the UDI-PI covers the variable information of the device such as lot number, expiry, etc. This ensures that each device can be traced back to its source and production history.
Regarding the UDI-DI number for IVD kits where components within the kits can be commercialized separately, the kits and every sellable part must have its own UDI number.
Translations
The EU IVDR requires the translation of labels and IFU content for multilingual markets. The regulations for translation into the local official language of the member countries of the European Union have been introduced to safeguard users against misinterpretation which can put the IVD’s safety and performance at risk. For instance, Article 15 of the Swiss regulation (‘IvDO’) requires labels and IFU in the three official languages of Switzerland (Italian, French, and German).
IVD labeling elements and placement
Legible versions of all applicable levels of labels should be provided (e.g., secondary packaging, primary packaging) and should be representative of the finished form. Specific requirements of relevant harmonized standards or Common Specifications are addressed in the labels and IFU. You will need to consider how to present all the necessary information, whether you need to increase the size of your labels, and how this will affect your labeling processes and labeling equipment. One way to reduce the amount of space needed on the labels is to use symbols. This also avoids having to provide the information in multiple languages. The regulations permit that the information supplied by the manufacturer can be provided as internationally recognized symbols following the EN ISO 15223-1 standard.
Labeling for software as IVDs
In addition to the standard labeling and IFU requirements, in case of Software as IVDs – the below must be available on the label,
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- hardware configurations;
- system requirements;
- downloading instructions; and
- emergency handling care.
Standalone software when provided in a hard drive can contain a hard copy of the IFU while a downloadable standalone software must have an eIFU.
Amendments in EU IVDR over previous directives
In addition to the above explained updates, some of the other additional requirements that manufacturers must bear in mind while preparing for the transition from IVDD to EU IVDR for their labels and IFU include:
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- Presenting the manufacturer’s information, address, and contact details;
- Ensuring legibility, font size, and contrast for optimal readability;
- Conveying the risks to users including those posed by the device itself and its detachable separate components;
- When multiple testing by a professional is carried out, a single set of instructions can be provided with additional copies available if requested by users;
- Making the eIFU available and keeping it up to date on the website. The reference to this must be available on the label;
- Emphasis is given to making the label content appropriate and user-friendly to the experience, technical knowledge, training, and education of the intended user;
- Supplementing the instructions with drawings and diagrams;
- While STERILE indication is covered in the IVDD, clearly indicating the sterilization methods used. For example, sterilization using ethylene oxide, irradiation, etc;
- Comprehensible instructions to be given on what to do if the sterile package is damaged must be outlined in the IFU as per Section 20.3 of Annex I;
- Presenting relevant hazard pictograms and complying with the requirement of (EC) No 1272/2008 in the case of devices containing a dangerous substance or a mixture;
- Complying with Regulation (EC) No 1907/2006 on safety data sheets for the safe use of chemicals;
- Maintaining consistent labels for devices that are for SINGLE USE across all countries in the European Union; and
- When there is no shelf life, provide the date of manufacturing. Devices with a shelf life should ideally provide the date in dd-mm-yyyy format.
Additional requirements for self-testing devices (Section 20.2 (u)) include:
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- Specimen type (e.g. saliva, urine, blood;
- Additional materials the user may need to do the testing;
- Contact information for advice and assistance; and
- The device name should not be ambiguous leading the user to misconstrue the intended use of the product.
Symbols and specific considerations for IVD labeling:
The below table contains some IVD symbols which are relevant under the EU IVDR:
Utilizing MedEnvoy’s Authorized Representative services to ensure compliance
As a manufacturer of IVDs, it is common to have multiple product lines with different sizes, kits, and components. The process of updating the labeling when there is a design change, product upgrade, regulatory update, etc. involves a structured approach. Additionally, keeping the labeling variability consistent across all product variations can be a logistical challenge. Strong data management to handle this level of complexity helps in the process. Contact MedEnvoy today to ensure your device meets all regulatory standards and safety requirements.
In conclusion, manufacturers should incorporate meticulous procedures to ensure that their EU IVDR labeling aligns with regulations for compliance and broader market access. These strategies should embrace a collaborative method involving various departments. The EU IVDR labeling prerequisites, as outlined in the EU IVDR guidelines, might appear overwhelming, even for an established manufacturer with a legacy device.
IVD labeling under the IVDR with MedEnvoy
If you have any questions regarding IVD labeling under the IVDR or require relevant training/consulting services, get in touch.