Medical Device Definition....
Information & Training. | Medical Devices.
The following are definitions of medical devices as detailed by regulatory bodies in the United States, Australia, Canada, European Union, New Zealand, South Africa, by the World Health Organization and the International Medical Device Regulators Forum (formerly the GHTF).Definition of a Medical Device. US FDA (Food and Drugs Administration)
Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines and medical lasers. If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration (FDA)as a medical device and is subject to premarketing and postmarketing regulatory controls.A medical device device is:
– “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
– recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
– intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
– intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
This definition provides a clear distinction between a medical device and other FDA regulated products such as drugs. If the primary intended use of the product is achieved through chemical action or by being metabolized by the body, the product is usually a drug. Human drugs are regulated by FDA’s Center for Drug Evaluation and Research (CDER). Biological products which include blood and blood products, and blood banking equipment are regulated by FDA’s Center for Biologics Evaluation and Research (CBER). FDA’s Center for Veterinary Medicine (CVM) regulates products used with animals. If your product is not a medical device but regulated by another Center in the FDA, each component of the FDA has an office to assist with questions about the products they regulate.
Medical Device Definition – European Union
There are three directives for medical devices:– the Active Implantable Medical Device (AIMD) Directive – 90/385/EEC
– the Medical Device Directive (MDD) – 93/42/EEC
– the In Vitro Diagnostic Device Directive (IVD) – 98/79/EC.
The Directives 90/385/EWG (AIMD) and 93/42/EC (MDD) have been updated by Directive 2007/47/EC
The following definition refers to the MDD, although most provisions are much the same under the other two medical device directives.
‘Medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
– diagnosis, prevention, monitoring, treatment or alleviation of disease,
– diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
– investigation, replacement or modification of the anatomy or of a physiological process,
– control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
An ‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device.
Medical Device Definition – Australian Therapeutic Goods Administration
A ‘medical device’ is any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related material:a) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:
– diagnosis, prevention, monitoring, treatment or alleviation of disease,
– diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
– investigation, replacement, modification, or support, of the anatomy or of a physiological process,
– support or sustaining life,
– control of conception,
– disinfection of medical devices,
– providing information for medical or diagnostic purposes by means of in-vitro examination of specimens derived from the human body;
and
b) which does not achieve its primary intended action in or on the human body by pharmaceutical, immunological or metabolic means, but which may be assisted in its intended function by such means.
Validation. Classification. Regulation. Requirements. Current best practices.
FDA cGMP’s. EU MDR’s / MDD’s.
FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
FDA Medical Device Classification. The FDA approach to Medical Device Classification.
EU Medical Device Regulation and Classification (per MDD’s).
New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
Quality System requirements to maintain compliant Validations.
Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
Medical Device Software Validation.
Medical Device Design Validation.
Electronic Signature, Electronic Records.
Life Cycle Approach to Validation.
Risk Identification. Documentation. DHR’s. DMR’s.
Etc. Etc. …
Information & Training presentation >>>
Medical Device Definition – Health Canada
As defined in the Food & Drugs Act:“device” means any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in
– the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical sate, or its symptoms, in human beings or animals,
– restoring, correcting or modifying a body function or the body structure of human beings or animals,
– the diagnosis of pregnancy in human beings or animals, or
– the care of human beings or animals during pregnancy and at and after birth of the offspring, including care of the offspring, and includes a contraceptive device but does not include a drug.
“sell” includes offer for sale, expose for sale, have in possession for sale and distribute, whether or not the distribution is made for consideration.
As defined in the Medical Devices Regulations (the Regulations):
“medical device” means a device within the meaning of the Act, but does not include any device that is intended for use in relation to animals.
“active device” means a medical device that depends for its operation on a source of energy other than energy generated by the human body or gravity. A medical device that transmits or withdraws energy or a substance to or from a patient without substantially altering the energy or the substance is not an active device.
“active diagnostic device” means an active device that, whether used alone or in combination with another medical device, is intended to supply information for the purpose of detecting, monitoring or treating a physiological condition, state of health, illness or congenital deformity.
Medical Device – New Zealand
Only products that meet the legal definition of a medical device are regulated as medical devices. Some products that can be marketed as medical devices in other countries are regulated as medicines in New Zealand.Legal Definition of a Medical Device
The legal definition of a medical device is contained in Section 2 of the Medicines Act 1981 and states;
Medical device means any device, instrument, apparatus, or contrivance, including component parts and accessories thereof, that is manufactured, imported, sold, or supplied for use wholly or principally on or by one or more human beings for a therapeutic purpose; and includes bandages and other surgical dressings, except medicated dressings where the medication has a curative function that is not limited to sterilising the dressing; but does not include —
(a) Any ultrasonic therapy apparatus within the meaning of section 2 of the Physiotherapy Amendment Act 1953:
(b) Except in section 38 of this Act, any irradiating apparatus within the meaning of section 2(1) of the Radiation Protection Act 1965:
(c) Any article of a kind or belonging to a class that is declared by regulations made under this Act to be a kind or class of article that is not a medical device for the purposes of this Act
Note that the Physiotherapy Amendment Act 1953 has been repealed. The definition contained in section 2 of the Act stated;
Ultrasonic therapy apparatus means any apparatus employing ultrasonic mechanical vibrations that is capable of being used for the treatment of the human body by way of physiotherapy.
Medical Device – World Health Organisation
‘Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:– diagnosis, prevention, monitoring, treatment or alleviation of disease,
– diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
– investigation, replacement, modification, or support of the anatomy or of a physiological process,
– supporting or sustaining life,
– control of conception,
– disinfection of medical devices
– providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.
Note: Products which may be considered to be medical devices in some jurisdictions but not in others include:
– disinfection substances,
– aids for persons with disabilities,
– devices incorporating animal and/or human tissues,
– devices for.in-vitro fertilization or assisted reproduction technologies
Medical Device – South Africa
The definition of a medical device in South Africa, as stated in the Medicines and Related Substances Control Act 101 of 165 (the Act), is:“medical device” means any instrument, appliance, material, machine, apparatus, implant or diagnostic reagent –
(a) used or purporting to be suitable for use or manufactured or sold for use in:
(i) the diagnosis, treatment, mitigation, modification, monitoring or prevention of disease, abnormal physical or mental states or the symptoms thereof; or
(ii) restoring, correcting or modifying any somatic or psychic or organic function; or
(iii) the diagnosis or prevention of pregnancy, and which does not achieve its purpose through chemical, pharmacological, immunological or metabolic means in or on the human body but which may be assisted in its function by such means; or
(b) declared by the Minister by notice, to be a medical device, and includes any part or an accessory of a medical device.
Medical Device – IMDRF
(International Medical Device Regulators Forum) formerly the GHTF (Global Harmonization Task Force)‘Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:
– diagnosis, prevention, monitoring, treatment or alleviation of disease,
– diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
– investigation, replacement, modification, or support of the anatomy or of a physiological process,
– supporting or sustaining life,
– control of conception,
– disinfection of medical devices,
– providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.
Note: Products which may be considered to be medical devices in some jurisdictions but not in others include:
– disinfection substances,
– aids for persons with disabilities,
– devices incorporating animal and/or human tissues,
– devices for in-vitro fertilization or assisted reproduction technologies.
Information & Training.
Medical Device:
- Validation. Classification. Regulation. Requirements. Current best practices.
- FDA cGMP’s. EU MDR’s / MDD’s.
- FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
- FDA Medical Device Classification. The FDA approach to Medical Device Classification.
- EU Medical Device Regulation and Classification (per MDD’s).
- New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
- Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
- Quality System requirements to maintain compliant Validations.
- Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
- Medical Device Software Validation.
- Medical Device Design Validation.
- Electronic Signature, Electronic Records.
- Life Cycle Approach to Validation.
- Risk Identification. Documentation. DHR’s. DMR’s.
- Etc. Etc. …
- Information & Training presentation >>>