Instructions For Use and Labelling FAQ

Q: What is the purpose of Instructions for Use (IFU)?

A: The purpose of an IFU is to provide clear and easy-to-understand instructions on how to use the device safely.

Q: What does the IFU need to include?

A: The EU MDR outlines a set structure for the IFU, which includes specific elements such as the device’s name, manufacturer’s information, intended purpose, indications, contra-indications, safety information, and more.

Q: Do manufacturers need electronic IFUs (eIFUs)?

A: Yes, certain medical devices are suitable for eIFUs, such as devices and accessories used by professionals, software, devices with built-in screen displays, fixed installed medical devices, and implantable devices.

Q: What should manufacturers consider when switching to an electronic IFU for their devices?

A: Manufacturers should conduct a risk assessment to ensure the safety of the eIFU compared to the paper version, consider the method of delivery, validation, online security, archiving procedures, and compliance with GDPR regulations if collecting user information.

Q: How do you create labels for Medical Devices under the EU MDR?

A: Medical device labels should comply with EU MDR regulations and include specific information, such as the product’s name, intended use, UDI code, storage conditions, and warnings. Labels should also be designed to be understandable to the intended user.

Q: What is required on Medical Device labels under the EU MDR?

A: New elements on the labels include the statement that the product is a medical device, translations into market-required languages, inclusion of UDI codes, indication of custom-made devices, and clarification of CMR status if applicable.

Q: What is ISO 15223-1:2020?

A: This is a new revision of the ISO 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.Using symbols on labels for medical devices can be extremely beneficial.

Q: What are the labelling requirements for Importers and Distributors of Medical Devices?

A: Importers must list their name and contact information on the device or its packaging, while distributors must ensure that devices are stored and transported in accordance with the manufacturer’s specifications while under their control.

Q: What are the levels of labelling and packaging for Medical Devices?

A: The levels of labelling are primary and secondary labels. The primary label contains essential information and is prominently displayed, while the secondary label provides more specific product information. The levels of packaging are primary, secondary, and tertiary, each serving different purposes in terms of protection, branding, and logistics.

Q: What should manufacturers consider when creating labels to comply with EU MDR?

A: Manufacturers must carefully plan their labels to comply with EU MDR labelling criteria and ensure high levels of quality and safety. Proper labelling is crucial to avoid regulatory enforcement issues and costly product recalls.