In this first part of this four part post we consider the varying Definitions of Medical Devices - ISO 13485 vs. EU versus USA
In the other parts of this Post we have …
- Classification of Medical Devices in the EU versus USA
- Medical Device Regulations in the EU (EMA)
- Medical Device Regulations in the UK (MHRA).
- The Medical Device Regulations of the United States (FDA)
- The Medical Device Regulations of the MDSAP Countries
- The Medical Device Regulations of the Rest of the World (WHO)
Table of Contents
- The 2020s will be a period of continuous Regulatory change
- Regulation of Medical Devices – the global scene
- Definitions of a Medical Device
- Definition of a Medical Device According to ISO 13485:2016
- Definition of a Medical Device According to the European Union
- Definition of a Medical Device in the USA by the Food and Drug Administration (FDA)
- The Consequences of the Variations in Definition
- List of typical medical devices
- Definition of High-risk Devices
- Definition of Medium-risk Devices
- Definition of Low-risk Devices
- Other Medical Device Types
The 2020s will be a period of continuous Regulatory change
The only certainty about this Post is that its content is almost certainly out-of-date. It is not an exaggeration to describe the current European regulatory scene as chaotic and the situation across the globe as being in a state of flux.
The situation described here refers to the situation at the time of writing, early January 2021. But by the time you come to read this the only certainty is that things will have changed.
Be forewarned and, if not an expert yourself, be sure to consult an expert to establish definitively the regulatory position regarding your medical device products and the markets you propose to sell them in.
Regulation of Medical Devices – the global scene
A medical device is a product that is used for medical purposes in patients, in diagnosis, therapy or surgery. If applied to the body, the effect of the medical device is primarily physical, in contrast to pharmaceutical drugs, which exert a biochemical effect. Specific regional definitions of medical devices vary slightly as detailed below.
Medical devices include a wide range of products varying in complexity and application. Examples include tongue depressors, medical thermometers, blood sugar meters, total artificial hearts, fibrin scaffolds, stents and X-ray machines.
The definition of a medical device in the Standard ISO 13485, Medical devices - Quality management systems - Requirements for regulatory purposes, is different from the official definitions, here they are…
Definition of a Medical Device According to ISO 13485:2016
ISO 13495:2016 defines a medical device in section 3.11 as…
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.
Definition of a Medical Device According to the European Union
Regulations of the European Union, Regulation (EU) 2017/745 defines a medical device as…
any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
- investigation, replacement, or modification of the anatomy or of a physiological or pathological process or state,
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
…and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
- devices for the control or support of conception;
- products specifically intended for the cleaning, disinfection, or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first subparagraph of this point.
The Health Product Regulatory Authority (HPRA) regulates medical devices in Ireland under European legislation with equivalent national authorities in each of the 26 other Member States and those non-EU Countries that subscribe to EU Regulation.
Regulations of the European Union, Regulation (EU) 2017/746 defines an in vitro diagnostic medical device (IVD), a special and separate category of medical device, as…
any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:
- concerning a physiological or pathological process or state;
- concerning congenital physical or mental impairments;
- concerning the predisposition to a medical condition or a disease;
- to determine the safety and compatibility with potential recipients;
- to predict treatment response or reactions;
- to define or monitoring therapeutic measures.
Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices.
Medical devices must not be mistaken for medicinal products. In the EU, all medical devices must be identified with the CE mark.
The ISO 13485 Lead Implementer Course includes an Implementation Handbook (100+ pages), Sample Procedures and Sample Forms
Definition of a Medical Device in the USA by the Food and Drug Administration (FDA)
Medical devices, according to the U.S. Food and Drug Administration (FDA) Regulations, include in vitro diagnostic (IVD) products, such as reagents, test kits, and blood glucose meters.
Certain radiation-emitting electronic products that have medical use or make medical claims are also considered medical devices.
Examples of these include diagnostic ultrasound products, x-ray machines and medical lasers.
The full definition of a medical device as per Section 201(h) of the Food, Drug, and Cosmetic Act, 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 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 its primary intended purposes. The term "device" does not include software functions excluded pursuant to section 520(o).
The Consequences of the Variations in Definition
While the definitions here and those used in other international jurisdictions are largely the same, where they differ can complicate things.
When applying for a marketing authorisation, marketing licence or equivalent, it is the legal definition applicable locally that takes precedence and regulatory authorities rigidly enforce these definitions being part of the regulations they exist to enforce.
In practical terms, it means that extending marketing approval from one jurisdiction to another is inevitably exacting, time-consuming, frustrating and, starting with the very definition of a medical device, fraught with opportunities to get things wrong. Hence, the existence of expert Regulatory affairs consultants.
If your organization doesn’t have such expertise in-house, you’d be well advised to seek one out for your next market expansion.
List of typical medical devices
Below are listed typical examples of high, medium and low risk medical devices. The array is mind-boggling – there are more than 10,00 different types of medical device registered globally with regulatory authorities.
Definition of High-risk Devices
High-risk devices are defined as life supports, critical monitoring, energy emitting and other devices whose failure or misuse is reasonably likely to seriously injure patients or staff. Examples include:
- Anaesthesia units
- Anaesthesia ventilators
- Apnoea monitors
- Argon enhanced coagulation units
- Autotransfusion units
- Cardiac defibrillator, external or internal
- Electrosurgical units
- External pacemaker
- Foetal monitors
- Heart-Lung Machine
- Infusion pump
- Invasive Blood pressure units
- Pulse oximeters
- Radiation-therapy machines
Definition of Medium-risk Devices
These are devices including many diagnostic instruments whose misuse, failure, or absence (e.g. out of service) with no replacement available would have a significant impact on patient care, but would not be likely to cause direct serious injury. Examples include:
- Ultrasound sensors
- Phototherapy units
- Human-implantable RFID chips
- Surgical drill and saws
- Laparoscopic insufflators
- radiant warmers (Adult)
- Zoophagous agents (e.g., medicinal leeches; medicinal maggots)
- Lytic Bacteriophages
Definition of Low-risk Devices
Devices in this category are those whose failure or misuse is unlikely to result in serious consequences. Examples include:
- Electronic thermometer,
- Breast pumps
- Surgical microscope
- Ultrasonic nebulizers
- Surgical table
- Surgical lights.
- Temperature monitor
- X-ray diagnostic equipment
Other Medical Device Types
The list of medical device types grows every year. The sector has an annual compound rate of growth (by value) of > 10% and this is forecast to continue indefinitely (not least because the target market is often older persons who have the money to buy new products). From a scientific, engineering, operational or commercial viewpoint, it’s a great sector to be working in.
And it's complicated!
As we’ve said previously applicable definitions, classification and regulation vary with location and, while there is a drive towards a uniform global system, we’re not there yet. Consequently, we’ll examine the situation in a series of 4 posts, namely,
- Definition of medical devices, ISO 13485 vs EU vs the USA
- Classification of Medical Devices, EU vs the USA
- Regulatory Regimes, EU, UK,
- Regulatory Regimes, USA, MDSAP Countries, and the rest of the World.