The medical devices industry is regulated and therefore there are many medical device terms that have specific meaning defined in the legislation. For example, in Australia, the Therapeutic Goods Act 1989 or the Therapeutic Goods (Medical Devices) Regulations 2002 give some words a specific definition. Other jurisdictions such as the USA and Europe have different legislation and instruments that give words defintions, that may be the same or different to each other and Australia.
Legislated definitions are important to the legal systems and regulators and so you need to understand these terms if you are part of this regulated industry. If you are a manufacturer or sponsor of regulated goods, such as medical devices, you should becareful about how you use words and phrases that have special legal definitions. Ideally you want to use them the same way as you regulator, espcially in documents that will be reviewed that regulator.
For those who don't supply medical devices, but are operating in the health, wellness or sports industries, knowing the legal meaning of these words can still be helpful. This is because these words can be used on labelling or in advertising and may trigger government or regulators to take action based on a misunderstanding of your product. Furthermore, making claims that are therapeutic can itself make you or your product subject to regulation.
In this article we have outlined some medical device terms that often have specific meaning within the health and medical technology industry. We haven't given definitions because they can vary between countries and can also have contextual meaning. However, you can, and should, check the definition of these in the countries that you are marketing you medical devices in.
Medical device terms that have regulatory meaning
The following medical device terms are often defined in legislation or key standards that are referenced by law or commonly used by regulators. They have particular meaning in some or all jurisdictions that regulate medical technology.
- Medical device
- Diagnosis
- Therapy, treatment
- Monitoring, screening
- Prevention (in the context of disease, ailment, or condition)
- Condition, disease, ailment
- Disability, injury
- Serious (in the context of condition, disease, or ailment)
- Healthcare professional
- Medicine
- Assurance (e.g., quality assurance, production assurance)
- State-of-the-art
- Diagnostic, companion diagnostic, in vitro diagnostic
- Exclude, excluded
- Exempt
Terms that may be misunderstood
The following terms are not commonly defined in legislation or standards, but they have a common or medical meaning that is important in the context of healthcare. If you use these terms differently, it could lead to misunderstanding by a regulator or customer.
If you are using these terms, try to be consistent with the industry and its stakeholders, and watch out for misunderstandings.
- De-risk, de-risking
- Risk appetite
- Cure
- Health advice
- Medical advice
- Chronic
- Best practice
- Pain management,
- Injury recovery or management
- Quality
- Prescribe, recommend
- Disclaim, disclaimer
- Contraception, conception
Key words
The following words have specific meaning in standards and legislation. These terms do not need to be avoided, but should be read with particular meaning within standards, legislation or regulatory guidance.
Regulators and professionals reviewing against standards will use these words as they are used in standards.
- Shall, should, can, may, must
- Normative
- Informative
Medival device terms that are confusing
The following terms are meaningless, self-contradictory, or confusing and should be avoided in the health and medical technology industry.
- Unregulated medical device
- Unregulated Software as Medical Device (SaMD)
- No risk, zero risk, and their synonyms
- 100% safe, completely safe, and the synonyms