Instructions for use are part of the labeling of medical devices and are subject to strict regulatory requirements, which will be tightened significantly with the entry into force of the MDR (PDF) relative to the provisions in previous Directives.
Definition of “Instructions for Use”
In accordance with the Medical Device Regulation, the term “instructions for use” refers to the information provided by the manufacturer to inform the user of a device’s intended purpose and proper use and of any precautions to be taken.
The instructions for use must be provided together with the device. By way of exception, instructions for use are not required for Class I and Class IIa devices if such devices can be used safely without any such instructions and unless otherwise specified in the MDR. Manufacturers which do not plan on providing instructions for use will have to confront the question as to whether their device can be used safely even without accompanying instructions for use as part of their risk management activities. It will be necessary for them to identify and evaluate potential risks and to explain why instructions for use are not of critical importance in this particular case.
If instructions for use cannot be dispensed with, manufacturers may have the option in certain cases to provide the instructions in electronic form. Regulation (EU) No. 207/2012 (PDF) on electronic instructions for use of medical devices will continue to apply in this regard for the time being, even under the MDR.
Minimum Content of Instructions for Use under the MDR
In accordance with the MDR, instructions for use for medical devices must contain certain key information. Aside from information about the product (name/trademark, product ID) and the manufacturer (name, address, contact information), information about the following is also required:
- intended purpose;
- indications and contra-indications;
- patient target group and intended users;
- specification of the clinical benefit to be expected;
- availability of the summary of safety and clinical performance (high-risk devices);
- the device’s performance characteristics;
- specifications which are required for appropriate use of the device;
- sterilization, final assembly, calibration, cleaning and disinfection;
- necessary qualifications for users;
- any reconditioning procedures;
- storage, transport, durability;
- combination with other devices, including accessories;
- maintenance and repair;
- symbols and identification colors.
Design of Instructions for Use
Instructions for use are to be designed in such a way as to satisfy regulatory requirements while at the same time being clear and understandable for the users specified in the device’s intended purpose. A structured and consistent design are of essential importance in this regard. In particular, it should be ensured that symbols are used in a consistent manner and that the information pertaining to intended use, handling, cleaning, maintenance, etc. is presented in a non-contradictory manner. Aspects which are not relevant for this specific device should be left out (e.g. no information about reconditioning if the device cannot be reconditioned).
The language in which the instructions for use must be provided is determined by the member states. The general rule under the MDR is that instructions must be provided in the languages accepted in the member states where the device is to be sold.
Relevance of Instructions for Use for Regulatory and Liability Purposes
Manufacturers are required to ensure that the instructions for use of their devices conform to the requirements of the MDR. If the instructions for use fail to conform to the provisions of the MDR, particularly those in Annex I Chapter III (Requirements Regarding the Information Supplied with the Device), this may result in the competent supervisory authority ordering a marketing or sales freeze.
Manufacturers could also face liability risks: after all, manufacturers could be held liable not only for injuries arising from the use of an unsafe or defective device, but also for injuries suffered by patients or users who used the device improperly because the instructions for use were confusingly formulated, wrong or incomplete. This also applies with regard to erroneous information in translated versions of the instructions for use. The liable party is the manufacturer in each case, regardless of whom the manufacturer hired to translate the instructions for use.back