ISO – International Organization for Standardization, is the international, non-governmental body for drafting and establishing technical and non-technical standards. These standards are developed by different committees within the ISO. Having around 165 member states, with one representative from each, ISO is a global entity catering to the needs of industry requirements.
Are ISO standards important?
The ISO medical device standards are the Bible for many countries, especially ones which do not have predefined regulations or processes. For regulated countries, in addition to their respective regulations and guidance, ISO standards are also preferred. The most popularly referred ISO standard is the ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes. In addition to general standards, ISO also publishes product-specific guidance such as for Implants, Orthopedic, Medical Electric Equipment, and many more.
Global ISO Requirements
In Europe, the European Commission has the Medical Device Regulation MDR 2017/745 and In-vitro Diagnostic Device Regulation IVDR 2017/746. These regulations provide a detailed framework for introducing a medical device in the European market. However, in addition to that, certain ISO standards may also be referred to for ensuring a better-quality product. Some of the many popularly used standards include:
ISO 14971:2019 Medical Devices – Application of Risk Management to medical devices
ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
IEC 60601-2-83 Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
The European Commission also has Harmonized Standards, developed by European Standards Organization CEN, CENELEC, or ETSI, per the international standards. It provides a list of the applicable harmonized standards for enhanced product safety and quality.
In the USA, the US Food and Drug Administration (FDA) has a Code of Federal Regulations (CFR) and Guidance.
CFRs are legally binding. Manufacturers must comply with the requirements of CFR
The guidance provides Agency’s thinking on regulatory issues. They are NOT legally binding
In addition to these, the FDA also accepts certain recognized consensus standards from different organizations such as ISO, CLSI, ANSI, IEC, CEN, etc. These standards may be used to justify a Declaration of Conformity for a product. The widely accepted medical device ISO standards are, but are not limited to:
ISO 10993 – Biological Evaluation for Medical Devices
ISO 14160 – Sterilization of Healthcare Products
ISO 11737 – Sterilization of Medical Devices
In Canada, the Standards Council of Canada (SCC) is the ISO member body. Similar to the US FDA, the Therapeutic Products Directorate (TPD) of Health Canada periodically releases a list of acceptable international or national standards for medical devices. Manufacturers can use these recognized standards in conjunction with the Health Canada’s Medical Devices Regulations (SOR-98/282) and the Guidance Documents, to prove product conformity and safe use in the market.
China‘s National Medical Products Administration (NMPA) is developing indigenous standards that more closely align with those of ISO. Biocompatibility testing is one avenue where the scope and requirements for China are more than that of the US/EU. Hence, NMPA has developed various biocompatibility testing standards which are to be used in addition to the ISO standard.
For the rest of the world’s medical device industry,
India encourages ISO certification for all its industries. The medical sector must be ISO 13485 compliant while the pharmaceutical sector must be ISO 9001 compliant for Quality Management Systems, in addition to other relevant and applicable ISO standards.
Japan’s The Japanese Industrial Standards Committee (JISC) is an ISO member body. The regulatory authority, Pharmaceutical and Medical Device Agency (PMDA) revised its Ordinance No. 169 in 2021 to closely align with the ISO 13485:2016 standard. The transition period is 3 years and must comply by March 25, 2024
For the Korean regulatory authority, aligning the requirements of Korean Good Manufacturing Practice (GMP) to that of ISO 13485:2016 is believed to be a step closer to entering the Medical Device Single Audit Program (MDSAP)
Russia’s Federal Service for Surveillance in Healthcare (Roszdravnadzor) is known to accept ISO 13485:2016 certification. Information on acceptance of other ISO standards cannot be confirmed. It does not accept market approvals in the US, EU, or other countries as a reference for market authorization in Russia
Australia’s Standard Australia is a member of the ISO, IEC, and ICSID. It strongly encourages the use of international standards, except where their use is ineffective or inappropriate and does not develop any national Australian standard for which there is already an international standard in existence. In 2019, TGA published Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019which provides a list of applicable conformity assessment standards.
Brazil’s ANVISA accepts Good Manufacturing Practices (GMP) along with the ISO 13485
Can QMS be established solely based on ISO standards?
For countries that do not have their own QMS regulations, the ISO standard can be used as a reference. For countries with established local regulations, and that accepts ISO, both ISO standard and local/national regulations must be considered.
Are ISO standards freely available?
No. ISO standards are available for purchase from the ISO official website. However, they do have FREE read-only formats available.
Comparing ISO standards to local regulations, which one takes precedence?
The local or national regulation always takes precedence over the ISO standard.
Can the manufacturer use an older version of an ISO standard for compliance?
No. Manufacturers must make sure they comply with the active or most recent version of the ISO standard. This is not restricted just to ISO standards but applies to National regulations too. Manufacturers must keep their QMS up to date with the latest requirements of the industry. The ideal way to be updated is to refer to the latest version of any Standard or Regulation.
“Corrective action” is the immediate address of an issue, whereas
“Preventive action” is addressed to reduce or stop the recurrence of the same error from happening again.
What is a CAPA?
Corrective And Preventive Action (CAPA) consists of a system of procedures to help improvise the non-conformances, undesirable outcomes and even field safety corrective actions of an organisation. CAPA must include the following steps:
Identify the immediate corrections to be taken
Implementation of corrective actions
Implementation of preventive action
Appropriate methods to evaluate the effectiveness
CAPA is a time-bound activity.
CAPA requirements for US FDA
In the US, the Title 21 CFR part 800-898 governs medical devices. The regulations contain CAPA reports that must meet specific FDA standards. All CAPA reports must be stored in a centralised database. This ensures that all quality staff are aware of the problem and can take appropriate action. A designated individual inside the organisation must also examine and approve CAPA reports. Furthermore, all CAPA reports must be available to the FDA upon request.
This article discusses the CAPA requirements in the US for one of the essential topics, Medical Device Reporting. Medical device reporting is any serious event caused by the medical device that results in serious injury or even death of a patient. To get a detailed insight on the topic, read our Field Safety Corrective Action (FSCA) – US FDA article.
In Europe, ISO standards are widely accepted. ISO 13485, an ISO standard that concerns medical devices, also sets forth the requirements of CAPA in QMS for every manufacturer. Below is an overview of the various titles under ISO 13485 relevant to CAPA.
The most crucial section in ISO 13485 is Clause 8, which contains guidance on monitoring and measurement of the effectiveness of the QMS in place.
The flowchart below summarises the processes in Corrective and Preventive Action.
ISO 13485:2016 Clause 8.5.2 & 8.5.3 requires documented evidence as stated below for a CAPA:
Determining the cause of non-conformities
Evaluate the need for action to ensure non-conformities do not re-occur
Plan and document the actions and implement the actions appropriately
Verify the action taken does not adversely affect the ability to meet the applicable regulatory requirements or safety and performance
Analyse the effectiveness of the corrective and preventive actions taken
Preventive actions to be proportionate to the effects of potential problems
Evaluating the need for action to prevent the occurrence of non-conformities
Why is CAPA necessary?
CAPA must address the issues that a medical device manufacturer may encounter. Issues like non-conformance (NC), customer complaints and any internal errors. It provides a structured process for analysing the causes of these issues and taking a step-by-step corrective action.
What is a CAPA report?
CAPA report is initiated because of non-conformances (NC), client complaints or any recurrent errors. In the case of NCs, the CAPA report addresses major and minor NCs and Opportunities for Improvement (OFIs). The CAPA report owner is the person responsible for the creation of the CAPA plan. In turn, the CAPA owner is also responsible for implementing the corrective actions within the prescribed deadlines mentioned in the report. Internal or external auditors review CAPA, which tracks effectiveness checks.
How does CAPA integrate with Quality Management?
A CAPA is followed to address critical issues raised from various defects in the process, such as Process failures Non-conformances Customer complaints R&D observations Field adverse event reports Product failures, etc.,
A CAPA impacts Management Review decisions, Design controls, Change management, Supplier management, Field issue resolutions, Regulatory compliance impact and others.
Medical devices are those products used to prevent, diagnose, treat, and monitor the many diseases known to humankind. Medical devices and medicines play an equally important role in treating human beings. To learn more about medical devices, read our article on the definition of a medical device. This article discusses the nomenclature of medical devices and examples of these.
What is the nomenclature of medical devices?
To simply put it, the nomenclature is the naming of a medical device. Although medical devices are classified into different risk classes, they should be named so that it is universally identified. Standardised nomenclature facilitates this easy identification.
A nomenclature is needed to simplify trade and tracking among the different regulatory authorities, Ministries of Health, and other organisations that regulate medical devices.
A standardised nomenclature aids in the following aspects:
Grouping and classification of medical devices.
Registration under different regulatory bodies or Ministries of Health
Streamlined procurement and distribution
Grouping of medical devices in various electronic health records and medical device databases
Vigilance reporting, field safety and post-market surveillance
The different device nomenclatures available are as follows:
GMDN or Global Medical Device Nomenclature.
EMDN or European Medical Device Nomenclature
UMDNS or Universal Medical Device Nomenclature System
Other nationally developed nomenclature systems
Global Medical Device Nomenclature (GMDN)
About 10% of countries use Global Medical Device Nomenclature worldwide. It is a system of internationally accepted descriptors used to identify medical devices. The GMDN Agency manages GMDN codes, a non-profit organisation.
GMDN is a 5-digit code containing the following information:
GMDN Term Name: Anaesthesia ventilator
GMDN Code: 34851
GMDN Definition: A mains electricity (AC-powered) stand-alone, automatic cycling device used to assist and control alveolar ventilation during general anaesthesia and is compatible with inhaled anaesthetic agents. It has fewer functions and is less complex to operate than an intensive care ventilator but adequately meets the patient’s ventilation needs for oxygen (O2) and carbon dioxide (CO2) exchange to maintain normal blood gas concentrations. The device provides a mechanical means to deliver the breathing gas to the patient in a controlled pattern. It is equipped with alarms to warn of changes in respiration or the onset of unsafe operating conditions.
GMDN was introduced for a variety of regulatory purposes. GMDN is based on the ISO 15225: Medical device nomenclature data structure’. Read more about the frequently asked questions about GMDN here.
European Medical Device Nomenclature (EMDN)
European Medical Device Nomenclature or EMDN is introduced due to Article 26 of EU Regulation 2017/745 of Medical devices and Article 23 of EU Regulation 2017/746 of in-vitro diagnostic medical devices. Like GMDN, it plays a considerable role in device nomenclature and serves various regulatory purposes. One of the primary uses is while registering a medical device in EUDAMEDwhere it is closely linked to UDI-DI.
Structure of EMDN
The European Medical Device Nomenclature is characterised by its alphanumeric structure and is established in a seven-level hierarchical tree where it clusters medical devices into three primary levels:
Categories: the first hierarchical level – alphanumeric.
Groups: the second hierarchical level – 2 numbers indicating group.
Types: the third hierarchical level – a series of numbers 1,2,3,4 and 5.
EMDN was adopted from the Classificazione Nazionale Dispositivi medici (CND) classification. The EMDN can be accessed at the EMDN list. European Medical Device Nomenclature categorises into three primary levels, categories, groups, and types. A category comprises several groups composed of various kinds of medical devices.
Universal Medical Device Nomenclature System (UMDNS)
Universal Medical Device Nomenclature System or UMDNS was developed by the Emergency Care Research Institute (ECRI). Many nations have adopted this standard around the world. UMDNS is used in inventory control, work order control, and regulatory systems applications. It is a 5-digit code unique code and a term for different types of medical devices. One can find the UMDNS code list here. UMDNS is updated monthly.
CND nomenclature or ‘Classificazione Nazionale Dispositivi medici’ was developed by Italian Ministry of Health. In addition to Italy, it is also used in Portugal and Greece. The guidance document on CND nomenclature explains the basic principles and structure of CND, which also applies to EMDN as EMDN was adopted from CND nomenclature. Following this, medical devices are clustered into three levels:
Is UDI the same as GMDN?
Both Unique Device Identification System (UDI) and GMDN are used in device identification. However, the two have some fundamental differences. UDI is inferior because of its lack of unity. It does not have a structure; therefore, device identification becomes more difficult with UDIs. Nonetheless, it is an effective tool for the traceability of medical devices. FDA utilises UDIs for medical device identification. The user guide to GUDID explains how the UDIs are managed in US FDA’s database, GUDID.
Can EMDN be accessed free of charge?
The EMDN is accessible to all stakeholders- free of charge. Hence, it can be utilised by a non-exhaustive list of stakeholders such as manufacturers, patients, research organisations, practitioners, hospitals, etc. The EMDN can also be downloaded from here.
Is there a guidance document that helps economic operators to map the EMDN information into the forthcoming EUDAMED database?
Yes, there are two guidance documents released by the EU commission
The simplest definition of a medical device is a product used for treatment except for medicines. It is imperative to understand if the product classifies as a medical device and apply the regulations after defining it properly.
An essential aspect of defining a medical device is its intended use. Intended use is the purpose of the device specified by the manufacturer. In this article, we have brought up the definition of “medical device” for a few major countries.
(a) any instrument, apparatus, appliance, software, implant, reagent, material or other article (whether used alone or in combination and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:
(i) diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;
(iii) investigation, replacement or modification of the anatomy or of a physiological or pathological process or state;
(iv) control or support of conception;
(v) in vitro examination of a specimen derived from the human body for a specific medical purpose;
and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or
(aa) any instrument, apparatus, appliance, software, implant, reagent, material or other article specified under subsection (2A); or
(ab) any instrument, apparatus, appliance, software, implant, reagent, material or other article that is included in a class of instruments, apparatus, appliances, software, implants, reagents, materials or other articles specified under subsection (2B); or
(b) an accessory to an instrument, apparatus, appliance, software, implant, reagent, material or other article covered by paragraph (a), (aa) or (ab); or
“Health products, such as equipment, apparatus, material, item or system with a medical, dental, or laboratory use or application for prevention, diagnosis, treatment, rehabilitation and that does not use contraception and pharmacological, immunological or metabolic means to perform the main function in humans, but can be assisted in their functions by such means.
Device means an instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, part or accessory of any of them, that is manufactured, sold or represented for use in
diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings or animals,
restoring, modifying or correcting the body structure of human beings or animals or the functioning of any part of the bodies of human beings or animals,
diagnosing pregnancy in human beings or animals,
caring for human beings or animals during pregnancy or at or after the birth of the offspring, including caring for the offspring, or
preventing conception in human beings or animals.
However, it does not include such an instrument, apparatus, contrivance or article, or a component, part or accessory of any of them, that does any of the actions referred to in paragraphs (a) to (e) solely by pharmacological, immunological or metabolic means or solely by chemical means in or on the body of a human being or animal; (instrument).
Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related items that are directly or indirectly used in the human body, including required computer software; its utility is mainly obtained through physical methods, not through pharmacology, immunology or metabolism, or although these methods are involved but only play an auxiliary role; its purpose is:
Disease diagnosis and prevention
Diagnosis, monitoring, treatment, mitigation or functional compensation of injury.
Inspection, replacement, adjustment or support of physiological structure or physiological process.
Life support or maintenance;
To provide information for medical or diagnostic purposes by examining samples from humans.
‘Medical device’ means any instrument, apparatus, appliance, material, or other article, whether used alone or in combination, including the software 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.
‘Medical device’ means 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 group of products are also considered as a medical device under MDR.
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 paragraph of this point.
Medical device definition in India
CDSCO governs medical devices in India. The definition of a medical device in India is as follows.
“Medical Device” means, –
(A)substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i),
(B)substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified in the Official Gazette under sub-clause (ii),
(C)devices notified from time to time under sub-clause (iv)
of clause (b) of section 3 of the Act.
Medical device definition in Japan.
A medical device in Japan is defined per PMD Act as,
The term “medical device” as used in this Act refers to appliances or instruments, etc. which are intended for use in the diagnosis, treatment, or prevention of disease in humans or animals, or intended to affect the structure or functioning of the bodies of humans or animals (excluding regenerative medicine products), and which are specified by Cabinet Order.
“Medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application, which—
(a)is intended by the manufacturer to be used for human beings for the purpose of-
(i)diagnosis, prevention, monitoring, treatment or alleviation of disease,
(ii)diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
(iii)investigation, replacement or modification of the anatomy or of a physiological process, or
(iv)control of conception; and
(b)does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means,
and includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device;
“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.”
Medical Device Definitions: A Comparison
Let’s compare the definitions to understand what is included in each country’s term ‘medical device’.
The table below shows the product types and countries that include and exclude the product type in the definition of the medical device.
Regions where MD definition includes the product type
Regions where MD definition excludes the product type
EU (MDD and MDR), Australia, China, Saudi Arabia, United Kingdom, Switzerland
US, Canada, Japan, India, Brazil
UK, Switzerland, India, Saudi Arabia, Australia, Canada, Japan, UK, EU (MDD and MDR), Brazil
In vitro reagent
US, MDR, Canada, Australia, China, Saudi Arabia, India, Switzerland
MDD, Japan, UK, Brazil
Contraception or Control of conception
UK, Switzerland, India, Saudi Arabia, China, Canada, MDD, MDR
Japan, Australia, US, Brazil
EU (MDR and MDD), Australia, China, Saudi Arabia, UK, Switzerland, Brazil
United States, Canada, Japan, India
Disinfection / Sterilisation of devices
Switzerland, India, Saudi Arabia, MDR
United Kingdom, China, Japan, Australia, Canada, MDD, United States, Brazil
Why are medical devices defined in every regulation?
Medical devices must be defined because each country has its own classification rules. According to the definition provided, some may not fall under the scope of a medical device. Manufacturers must first look into the definition before classifying the medical device. Anyone must first begin with definitions before diving deep into regulations. Most regulations have the definitions initially, whereas countries like Australia have it mentioned near the end of regulations.
If my product is classified as a device in country A, will it be the same everywhere?
Most countries have similar device definitions. However, it is essential to go through the regulations of the respective country you decide to market in. This will define the exact medical device for the specific country.
Does the classification of the product differ the same as variations in definitions?
Each country’s classification rules must be followed where the device is subjected to.