Overview of Legislation and Regulations Applicable to Electronic Instructions for Use (Electronic Labeling)
Current US and EU regulations allow manufacturers to use eIFUs with:
- Active Implantable Devices and their accessories,
- Implantable Devices and their accessories,
- Fixed Installed Medical Devices,
- Medical Devices and their accessories fitted with a built-in visual display screen
- In Vitro Diagnostic Medical Devices
that are intended for Professional Users, and sold within the US or EU, who need instructions for use for medical device products.
Applicable Legislation, Regulation and Guidelines
EU - European Union
US - United States
Definitions for use in eIFUs From European Regulations and Guidelines
From Commission Regulation (EU) No 207/2012 on electronic instructions for use of medical devices (LINK)
‘fixed installed medical devices’ means devices and their accessories which are intended to be installed, fastened or otherwise secured at a specific location in a healthcare facility so that they cannot be moved from this location or detached without using tools or apparatus, and which are not specifically intended to be used within a mobile healthcare facility
‘Professional users’ means persons using the medical device in the course of their work and in the framework of a professional healthcare activity
‘instructions for use’ means information provided by the manufacturer to inform the user of the device of its safe and proper use, of its expected performances and of any precautions to be taken as outlined in the relevant parts of point 15 of Annex 1 to Directive 90/385/EEC and of point 13 of Annex I to Directive 93/42/EEC
From MEDDEV 2.1/1 – Guidelines on Definitions in Directives 93/42/EEC & 90/385/EEV (LINK)
Devices - accessory
The definition of the term "medical device" together with the definition of "accessory" is determinant for the delimitation of the field of application of Directive 93/42/EEC. A slight difference exists between the definition in article 1(2) (a) of Directive 93/42/EEC and in article 1(2) of Directive 90/385/EEC.
Following the latter directive, accessories are by definition medical devices, whilst following Directive 93/42/EEC, a distinction is made between "devices" and "accessories". Therefore within the meaning of Directive 93/42/EEC, accessories are products in their own right and, although being treated as devices (article 1(1)) do not follow, as a general rule, the classification of related devices in conjunction with which they are used.
Accessories are therefore following Directive 93/42/EEC to be classified in their own right.
Definition of "accessory"
The question whether a product is a "device" or a "accessory" has not practical consequence. Following article 1(1) of Directive 93/42/EEC, "accessories shall be treated as medical devices in their own right". Therefore the main question is whether a product with a rather remote link to a medical use can still be considered as "accessory" (article 1(2)b) and as a matter of consequence is covered by the directive.
The definition of "accessory" requires that the accessory is specifically intended by the manufacturer of the accessory to be used together with a device. The intended use of the accessory must be such as to enable a device to be used in accordance with its intended use. Therefore a product can only become an accessory to a medical device if the manufacturer of such a product establishes an intended use in conjunction with one or several medical devices.
Examples for accessories depending on defined circumstances of device-related use:
- sterilizers for use in a medical environment,
- pouches for packaging re-sterilised medical devices,
- specific battery chargers for battery driven electromedical devices,
- contact lens care products, disinfectants specifically intended for invasive medical devices
- special water treatment device for use in conjunction with dialyzing machines,
- gas cylinders/pressure release devices for use in conjunction with anaesthesia machines.
Definition of "manufacturer"
Users in-house manufacturing
The Directive defines a manufacturer as the natural or legal person responsible for defined manufacturing activities related to a device with a view to its being placed on the market under the manufacturers own name. The reason for this link with the placing on the market is that the directives aims to subject to its protection requirements the transaction of a device from the sphere of a manufacturer towards the public. The directive does not provide any specific provisions for the case where a device is manufactured by the user (for example, a hospital) without being transferred to another person. The decision to which extent such in-house manufacturing activities by hospitals are subjected to legal requirements, belongs therefore to the national legislator. This relates however exclusively to such in-house manufacturing activities where a device remains within the users, but not to cases where, for example, a hospital produces orthopaedic devices for use with patients.
From MEDDEVB2.4/1 Rev.9 – Guidelines on Classification of Medical Devices in Directive 93/42/EEC (LINK)
Instructions for use
Instructions for use are not required for Class I and IIa devices if these devices can be used safely without any such instructions (Annex I Section 13.1. of Directive 93/42/EEC).
Any device which is intended:
- to be totally introduced into the human body or,
- to replace an epithelial surface or the surface of the eye,
by surgical intervention which is intended to remain in place after the procedure.
Any device intended to be partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least 30 days is also considered an implantable device.
One of the key elements in defining an implantable device is the concept of "procedure". Thus an implantable device must remain in the patient after the procedure. A "procedure" must be understood in this context to include the surgical procedure during which the implant is placed into the body and the immediate post-operative care that is associated with the procedure. The "procedure" does not extend to the conclusion of the therapeutic treatment, e.g. the removal of an implant must be considered to be another "procedure". Thus a plate used to reduce a fracture of the bone is an implant even if it is taken out after the fracture has healed. In this case the placing of the plate and its explanation are two different surgical procedures.
Some partially implanted devices are deemed to be implants. For instance, if an operation is carried out specifically to place an infusion port into the body, then such an infusion port would remain for at least 30 days after the procedure and consequently be an implant. However, a non-tunnelled central venous catheter which is intended for use for temporary vascular access and intended to be removed after 7 – 10 days is not a long-term implantable device. Nor would a suture used for skin wound closure that is taken out prior to 30 days be considered an implant.
Critical anatomical locations
For the purposes of the Directive 93/42/EEC, ‘central circulatory system’ means the following vessels:
arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior.
For the purposes of the Directive 93/42/EEC the ‘central nervous system’ means brain, meninges and spinal cord.
Active medical devices
Any medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to be active medical devices. Stand alone software is considered to be an active medical device.
The concept “act by converting energy” includes conversion of energy in the device and/or conversion at the interface between the device and the tissues or in the tissues.
The concept of “significant changes” includes changes in the nature, level and density of energy (see Rule 9). This means that for instance an electrode is not an active device under this classification system as long as the energy input is intended to be the same as the energy output. For instance, resistance in a wire that causes minor changes between input and output cannot be considered to constitute "significant change". However, electrodes used in electrosurgery for cutting tissues or cauterisation are active devices because their operation depends on energy provided by a generator and their action is achieved by conversion of energy at the interface between the device and the tissue or in the tissue. Electrodes intended for E.C.G. or E.E.G are normally not active devices because they do not normally act by conversion of energy.
However, it should be understood that an electrode, which is an accessory of an active implant, is covered under the relevant Directive for active implants. Further information on this issue can be found in "Guidelines relating to the application of the Council Directive 90/385/EEC on active implantable medical devices5.
The application of energy from the human body does not make a device "active" unless that energy is stored within the device for subsequent release. For instance, energy generated by human muscle and applied to the plunger of a syringe (thus causing a substance to be delivered to a patient) does not make this syringe an "active device". However, if a drug delivery system depends upon manual winding to preload a spring which is subsequently released to deliver a substance, then the device incorporating the spring is an "active device".
Medical devices using prestored gases and/or vacuum as a power source are regarded as active devices, e.g. gas mixers with anaesthesia machines and gas powered suction pumps.
Heating/cooling pads intended only to release stored thermal energy are not active devices because they do not act by conversion of energy. However, heating/cooling pads which act by chemical action (e.g. endothermic or exothermic reaction) are active devices as they are converting chemical energy into heat energy and or vice versa.
Radioactive sources that are intended to deliver ionising radiation are regarded as active medical devices, unless they are radiopharmaceuticals as defined in article 1 of Directive 2001/83/EC or radioactive implants as defined in article 1 of Directive 90/385/EEC.
Definitions for use in eIFUs From US Regulations and Guidelines
From 21 CFR 801.109 (LINK)
Sec. 801.109 Prescription Devices
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which "adequate directions for use" cannot be prepared, shall be exempt from section 502(f)(1) of the act if all the following conditions are met:
(a) The device is:
(1)(i) In the possession of a person, or his agents or employees, regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device; or
(ii) In the possession of a practitioner, such as physicians, dentists, and veterinarians, licensed by law to use or order the use of such device; and
(2) Is to be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice.
(b) The label of the device, other than surgical instruments, bears:
(1) The statement "Caution: Federal law restricts this device to sale by or on the order of a ____", the blank to be filled with the word "physician", "dentist", "veterinarian", or with the descriptive designation of any other practitioner licensed by the law of the State in which he practices to use or order the use of the device; and
(2) The method of its application or use.
(c) Labeling on or within the package from which the device is to be dispensed bears information for use, including indications, effects, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the device can use the device safely and for the purpose for which it is intended, including all purposes for which it is advertised or represented: Provided, however, That such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. Upon written request, stating reasonable grounds therefor, the Commissioner will offer an opinion on a proposal to omit such information from the dispensing package under this proviso.
(d) Any labeling, as defined in section 201(m) of the act, whether or not it is on or within a package from which the device is to be dispensed, distributed by or on behalf of the manufacturer, packer, or distributor of the device, that furnishes or purports to furnish information for use of the device contains adequate information for such use, including indications, effects, routes, methods, and frequency and duration of administration and any relevant hazards, contraindications, side effects, and precautions, under which practitioners licensed by law to employ the device can use the device safely and for the purposes for which it is intended, including all purposes for which it is advertised or represented. This information will not be required on so-called reminder--piece labeling which calls attention to the name of the device but does not include indications or other use information.
(e) All labeling, except labels and cartons, bearing information for use of the device also bears the date of the issuance or the date of the latest revision of such labeling.
From Draft Guidance for Industry and FDA Staff - Design Considerations for Devices Intended for Home Use (LINK)
A professional healthcare facility is an environment where operators with medical training are continually available to use devices when patients are present. This includes but is not limited to hospitals, long-term care facilities, nursing homes, emergency medical services, clinics, and outpatient treatment facilities.