Engineered medical devices are introduced to the market for use in clinical scenarios. From a user’s perspective, the safe and effective usage of a medical device is highly influenced by providing appropriate accompanying information with the device labels and user instructions.
An international standard that defines the information to be supplied by the manufacturer of Medical Devices is ISO 20417, with the latest version as ISO 20417:2021. Besides, ISO 15223 stands for requirements that identify requirements for symbols used in medical devices with information to be supplied by the manufacturer. These two standards are taken into consideration hand in hand by the manufacturer(s).
No more EN 1401:2008
EN 1041:2008 was the standard that discussed requirements for information to be supplied with a medical device that complied with the requirements per Medical Device Directive (MDD). The transition from MDD to Medical Device Regulation (MDR) imposed EN 1041 to be replaced with ISO 20417, which supersedes EN 1041 with additional requirements aligning to the MDR. The ISO 20417:2021 is not yet added to the harmonized list of European MDR.
ISO 20417:2021 lays requirements that stay in concurrence with the below EU Regulations:
- EU MDR 2017/745
- EU IVDR 2017/746
The manufacturer must consider the Risk Management process (ISO 14971) and Usability Engineering process (IEC 62366) while determining the relevant information for the device, including the information for safety.
Here is what you need to know
The standard specifies generally applicable requirements. However, for a specific product group, the manufacturer must focus on the unique needs of the particular medical devices or a group of medical devices. The standard details about various elements to be as part of the information supplied with the medical device:
- Units of measurement: Numerical indications of parameters expressed in SI units, units relevant to specific product standards, and other units relevant to clinical convention.
- Graphical Information: Any graphical information in the form of symbols, pictorial representations, and artwork form the meaning to be explained in the accompanying documentation (manual, user guide, etc.)
- Country and language information: Country information should be supplied by the manufacturer recognizing the country name in plain text and in its national language. The language used should clearly link the data.
Example: A Russian section should be indicated as ‘Русский’ or ‘ru’ or ‘rus’.
- Address and date format: Address of manufacturer, distributor, importer, or authorized representative must contain street/road, number/house/floor, city, state/region, postal code, and country. If a corporate postal code is to be used, street/road and number/house/floor may be omitted. The date of the manufacturer should be in the YYYY-MM-DD, YYYY-MM, or YYYY format.
- General requirement: Any medical device/accessory should have the model number, catalogue number, and commercial product name linked with the unique device identifier (UDI) for identification and traceability purpose.
Information to be provided on the website
The manufacturer’s website must maintain up-to-date information regarding the general information required to identify the device and the manufacturer and provide performance and safety information. Instruction for Use and sample labels can also be included on the website. However, the website providing the e-IFU of the devices rather than paper form must meet the following criteria:
- IFU should be published in a generally used format readable by publicly available software.
- It must be safeguarded from hardware and software intrusion.
- It must be delivered, so that server unavailability and display problems are kept to a minimum.
- It must specify which languages the manufacturer published the e-IFUs in.
- The displayed Internet address must be steady and immediately accessible for at least two years following the expiry date of the last manufactured device.
- All prior electronic versions of the instructions for use and publication date must be made available on the website.
Information to be supplied on the Label
- Identification of the Manufacturer: The label should have the name/trade name, the address of the manufacturer, and the authorized representative (if the manufacturer doesn’t have the address within the region).
- Identification of the device: The medical devices/accessories should clearly mention themselves, like ‘Pulse Oximeter’ or ‘Infusion Pump’ for identification. Storage or handling conditions, operating instructions, and necessary warnings or precautions should be expressed along with relevant symbols and colours for special category devices. If e-documents are available, they should be indicated. Information about the usability of a device, such as single-use or reusable, should be provided. In the case of reuse, the maximum number of allowable reuses or processing cycles is expected. If any device contains medicinal substances and is in direct contact with the patient, details about the strength, quantity, or portion of that substance should be presented.
Durability of the markings
- Label markings of the medical device or its accessories are required to be in such a way that they maintain the durability and are readable throughout their lifetime or shelf-life period, which shall not be affected under the claimed environmental and mechanical conditions of the device usage.
- The standard specifies certain testing aspects to test the durability of the labelling, such as rub tests that involve water, ethanol, and IPA. The projected lifetime of the device must be taken into account while defining the test cycles.
Information for the Instruction For Use
The information provided in the instructions for use (IFU) is equivalent to that needed on the labels.
- The details identifying the device/accessory, manufacturer/authorized representative, and device’s general information are the standard information that should be included in an IFU.
- A detailed description of the risks associated with sterility, storage, and handling should be added.
- Furthermore, if the device contains a medicinal substance, such as a human blood/plasma derivative, tissues or sales of animal or human origin, and animal tissue derivatives, the IFU must provide descriptive and precise information.
- If the CMR/endocrine disruptor content of the device exceeds 0.1 per cent by weight, the IFU must include information regarding it along with the treatments for vulnerable groups such as children and pregnant and nursing women.
- Finally, the IFU should consist of information regarding the qualitative composition and quantitative data of the major constituents that are absorbed or locally diffused to produce the primary intended effect. Example: Details about the composition in mg/g/ml, and quantitative details such as Hydroxide – 0.5mg, Benzoyl – 1.2mg, etc., used in a medicated Band-Aid, to attain the principal action of healing as the drug gets absorbed by the wound.
Additional information to be supplied with the medical device or an accessory
- Importer and Distributor: A label can also include the name/trade name and the registered address of an importer or a distributor.
- Repackaging: If any entity modifies the original manufacturer’s packaging and manipulates any medical device/accessory, the name and address of such entities should be printed on the label.
- Translations: If the translation of documents such as IFU and label is required by any region, then the details about the translator can be included in the label.
- Regulatory proofs: To check the authenticity of the documents and details supplied by the manufacturer, various regulatory references, compliance and classification graphics, and official guidance details must be provided.
ISO 20417:2021 provides more clarity on the information supplied with the medical device compared to the obsoleted EN1041. Since the standard is yet to be harmonized by the MDR, the manufacturer should not rely solely on this standard but refer to this standard in conjunction with the MDR, where the requirements of the MDR takes preference when any conflict arises. Manufacturers are required to update their accompanying information documentation based on ISO 20417 to better comply with the regulatory needs of medical device labelling and information.