Medical device testing is a crucial step in manufacturing a product. This mandatory process ensures that the medical device is safe and effective. Testing of medical devices proves that the product complies with the standards and regulations of a country.
Moreover, it also sheds light on any product defects. This article discusses the testing requirements and the applicable standards.
Medical device testing applies to all medical devices, in-vitro diagnostic devices, combinational products, and active implantable devices. Some common testing of medical devices is given below:
Electrical safety tests
Functional safety tests
Performance tests
Electromagnetic compatibility (EMC) tests
Electromagnetic Interference (EMI) tests
Immunity Tests
Biocompatibility tests
Chemical testing
Cybersecurity tests (applicable to SaMDs or software that store data)
Storage and Transport
Ingress Protection
Medical device testing is crucial as the device intended for patient use must be safe. The tests a medical device must undergo depend on the device’s type. To explain further, medical equipment like a ventilator must undergo an electrical safety test.
At the same time, a device such as a cannula requires appropriate biocompatibility tests. Hence, the choice for a practical device test is taken with the help of the medical device’s intended use.
The testing procedure should be logical and must begin with a risk analysis. After identifying the failure mechanisms and hazards associated with a device, testing strategies and processes can be devised to quantify the size of these risks.
As a result, the purpose of a test method and procedure is to offer evidence that the hazards connected with a device are insignificant or, at the very least, acceptable when weighed against the benefits received from its use.
Types of medical device testing
Medical device testing is broadly categorized into physical, chemical/biological and cybersecurity testing. Physical testing involves the tests such as electrical testing, MRI safety, functional safety tests and EMC tests.
IEC 60601 series is a widely accepted technical standard for the safety and performance of electrical equipment. EMC/EMI tests ensure that the overall device is compatible with other medical devices and works optimally in the device environment when subjected to interference and immunity.
Conformance to this standard provides that medical equipment does not create electromagnetic fields that could impair the operation of other devices in the usual environment.
Chemical or biological testing help achieve device compatibility with the surface of the skin. Medical devices that contact skin must comply with the ISO 10993 series- Biological evaluation of medical devices.
For this, the manufacturer must consider the choice of material used compatibility between device materials and the biological tissues, cells, and body fluids. Testing methods like stress, shear testing, and ageing tests are performed so that the final product causes the least quality concerns.
Cybersecurity testing is crucial to medical devices so that risks such as unauthorised access to data and breaches are identified, and their occurrence minimised.
A common standard followed for medical device software is IEC 62304 and ISO27001. IEC 62304 standard specifies the life cycle requirements for medical device software, whereas in ISO 27001 focuses on data and information security.
It should be noted that each of the above standards is closely related to the ISO standard for risk management of medical devices (ISO 14971).
The risks associated with the medical device should be correctly identified, and appropriate tests should be done, proving that the relevant standards are met. Please read our article on global ISO requirements for a better understanding of the ISO standards.
Testing requirements around the world
To fully comply with the regulations of each country, one must also align with the testing standards accepted within each country. ISO and IEC standards are accepted across the globe.
Compliance with these ensures that the devices can be marketed without any major difficulties. This article discusses the testing standards followed in major medical device markets.
In Europe, close to 80% of electrical and electronic standards follow the various IEC International Standards. Standards for electromedical equipment include IEC 60601 series standards for the requirements for high-frequency surgical instruments, short-wave therapy equipment and so on.
The EU from time to time releases the harmonized standards list which are the most acceptable standards for the EU compliance.
In the US, accepts certain ISO standards however there are a list of recognized consensus standards that the FDA accepts for medical devices in the US. These include ANSI, AAMI, ATSM and so on.
ANSI standards are applicable to a variety of industries like the ISO whereas AAMI testing standards are specific to medical instruments and ATSM standards are specific for materials used in medical devices.
Testing standards ensure that the medical device is fit for use not just for the patient but also for the healthcare professionals handling them. Most countries do not have stringent requirements for testing standards, but it is recommended that the devices have some form of tests done.
Why are risk management and testing standards closely linked?
Risk analysis is a crucial step in designing a medical device. Certain identified risks can be managed with a minor change in the initial stages of the manufacture and these can be identified with the help of an appropriate test.
Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.
A Label is the written, printed, or graphic information that goes on the packaging of the medical device.
Instructions For Use (IFUs) or Package Insert is the essential information accompanying the medical device for its safe and effective use by the user. It can be a single to multiple-page document.
Labelling is the content that goes on the Label or IFUs.
What are the minimum requirements for labeling?
The ISO has published many standards applicable to the medical device industry. Some of them are as below:
Standard Number
Standard Name
ISO 18113
In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 1, 2, 3, 4 and 5
ISO 28219
Packaging – Labelling and direct product marking with linear bar code and two-dimensional symbols
Medical devices – Information to be supplied by the manufacturer
ISO 14025
Environmental labels and declarations – Type III environmental declarations – Principles and procedures
ISO 14021
Environmental labels and declarations – Self-declared environmental claims (Type II environmental labelling)
ISO 14020
Environmental labels and declarations – General principles
ISO 22742
Packaging – Linear barcode and two-dimensional symbols for product packaging
There are more specific product-oriented labelling standards available.
ISO 20417 has defines information to be disclosed by the manufacturer. Every medical device manufacturer, distributor, importer, or Authorized Representative is bound to comply with the standard before placing the device on market. The requirements are as follows:
Information on Label
Manufacturer details – Trade Name, address, country
Product description.
Product identification – model or catalogue number, Lot number, serial number, expiry date, UDI,
Storage instructions
Operating instructions
Warning or precautions
Presence of any harmful substances (>0.1% w/w), biological origin substances, medicinal substances, nanotechnology materials
Electronic IFUs (if available)
Mention of: Single-use/ Single patient multiple-use / Reuse / Limitation on reuse
If Sterile and method of sterilization
Explanation of safety-related colours
Information on Packaging
Name and address of the manufacturer or an authorized representative
UDI
Production controls – lot number, serial number, expiry date
Model number, catalog number, commercial name
Mention of: Single-use/ Single patient multiple-use / Reuse / Limitation on reuse
Storage or special handling requirements
Any special requirements for battery-powered medical device
Contraindications, warnings, or precautions
Information in IFUs
General information (as above)
Intended Use of the medical device
Safety information
Performance of the medical device
Any residual risk associated with the use of the medical device or its accessory
Any known contraindications
Document control number of the IFU
Safe disposal information
Any specific instructions for handling or preparatory treatment
Any warnings, precautions, or limitations
If any accessories or indicators are provided along with the device, instructions on their use to be provided in the IFU.
Technical description
The harmonized ISO standard makes sure true and uniform information is conveyed to a lay/common person.
Global Labelling Requirements
Most countries have a mandatory requirement for the IFUs or Labels in their local language. To streamline this requirement, ISO 15223 standard provides a list of signs and symbols that depict common terms such as Manufacturer, Lot number, storage conditions, Expiry, eIFU and many more.
The uniform symbols help in identifying the necessary information without the language barrier. Another advantage is it saves significant label space.
FAQs
Is it necessary to follow the ISO standards?
It is advisable to develop a medical device in compliance with the applicable harmonized standards. This shall favor in smooth marketing of the product along with its competitors.
Is it necessary to brief the symbols in IFU when symbols from standards are used?
Yes, it is required to brief every symbol in the IFU that is used on the label of the product.
Can a distributor or an importer label be affixed separately apart from the main label?
Yes, it is also allowed to affix these labels separately on the product. This is because one manufacturer may have several distributors or importers within EEA.
Is it necessary to create dedicated labels for accessories of medical devices?
Yes, it is. Not every time the accessory is shipped along with the medical device and it is required to identify them with appropriate labels.
If the manufacturer wants to provide an eIFU how to indicate this on the label?
Firstly, not all the medical devices are eligible for eIFU provision. Regulation 207/2012 states what are the categories of MDs that are eligible for eIFU.
What is the deadline to implement UDI carrier on device labelling?
Article 123.3.f states these timelines as:
Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.
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 International Organization for Standardization. Having around 165 member states, with one representative from each, International Organization for Standardization is a global entity catering to the needs of industry requirements.
Are ISO standards important?
The International Organization for Standardization medical device standards are the Bible for many countries, especially ones which do not have predefined regulations or processes.
In addition to general standards, ISO also publishes product-specific guidance such as for Implants, Orthopedic, Medical Electric Equipment, and many more.
Global International Organization for Standardization 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 International Organization for Standardization 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 International Organization for Standardization, CLSI, ANSI, IEC, CEN, etc.
These standards may be used to justify a Declaration of Conformity for a product. The widely accepted medical device International Organization for Standardization 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 International Organization for Standardization 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 International Organization for Standardization standard.
For the rest of the world’s medical device industry,
India encourages International Organization for Standardization certification for all its industries. The medical sector must be International Organization for Standardization 13485 compliant while the pharmaceutical sector must be ISO 9001 compliant for Quality Management Systems, in addition to other relevant and applicable International Organization for Standardization.
Japan’s The Japanese Industrial Standards Committee (JISC) is an International Organization for Standardization member body. The regulatory authority, Pharmaceutical and Medical Device Agency (PMDA) revised its Ordinance No. 169 in 2021 to closely align with the International Organization for Standardization 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 International Organization for Standardization 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 International Organization for Standardization 13485:2016 certification. Information on acceptance of other International Organization for Standardization 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 International Organization for Standardization, 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 International Organization for Standardization 13485
FAQs
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.
Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.
Good manufacturing practices are the procedures that must be followed in order to comply with the guidelines set forth by regulatory agencies that oversee the authorization and licencing of the manufacture and sale of medical devices.
In this article, we will discuss the Significant changes that were made in the latest 2022 Regulations, which supersedes the 2013 version.
In Art 35 2022 GMP Document, under the document review and archive section, it is explicitly mentioned that – “All digitally stored documents and records shall be backed up.”
In Art 71 2022 GMP Document, under the Personal health and hygiene section, it is now clearly explained that – “Any individual who, upon medical examination or observation by supervisors, appears to be in a health condition which could affect the product shall be removed from operations until the health condition is deemed adequate.”
In Art 87 2022 GMP Document underlabels and instructions for use, there is an additional point which states – “In the case of importers, the approval documentation referred to in “Labels and instructions for use” article may be recorded in a specific document in lieu of the history record of the product.”
In Art 112 2022 GMP Document under Distribution Records section, it is now mentioned as:
Each manufacturer shall maintain distribution records which include or reference:
I – the name and address of the consignee.
II – risk: combination of probability of occurrence and severity of damage.
III – any number control used for traceability.
Previously in the 2013 GMP document, it was mentioned as:
Each manufacturer shall maintain distribution records, including or making reference to: (i)Names and addresses of the consignee; (ii) Identification and amount of products shipped, with shipment date; (iii) Any numerical control used for traceability.
In Art 114 2022 GMP Document under Identification and traceability of batch production units’ section, there is an additional point added which states- “Each manufacturer shall establish and maintain a program for maintenance, adjustment and, where necessary, cleaning of equipment to ensure that all manufacturing specifications are met.” This is in addition to the identification of the units that are manufactured with every product history record.
In Art 118 2022 GMP Document, under the Non-conforming components and products section, there is an additional point added which states – “The disposal of the products referred to as “non-conforming” shall be documented, and a record of the justification and manual or electronic signature of the person-in-charge for the disposal of such non-conforming products or components shall be kept.”
In Art 120-VIII 2022 GMP Document, under the Corrective and preventive actions section, there is additional information added which states – Each manufacturer shall establish and maintain procedures to determine the collection of products and other field actions for those products that are already distributed. The quality process to determine the corrective actions in regard to the identified potential causes shall be based on a valid statistical technique for detecting recurring quality problems, where applicable.”
In Art 123 2022 GMP Document under the Quality Audit section, there is an additional point added which states – “Those in charge of conducting the quality audit cannot be directly responsible for the matters under audit.”
CHAPTER 10 in 2022 GMP Document (Final Provisions) is additionally introduced – The chapter includes rules such as:
“The documentation evidencing compliance with the requirements set out in this Resolution shall be made available whenever requested by the health regulatory agencies.”
“Failure to comply with the provisions contained in this Resolution constitutes a health violation, under the terms of Law No. 6.437, of August 20, 1977, without prejudice to applicable civil, administrative and criminal liabilities”
“The following are hereby revoked: I – the Resolution of the Collegiate Board of Directors – RDC No. 16, of March 28, 2013, published in the Federal Official Journal No. 61, of April 1, 2013, Section 1, p. 75;
II – Normative Instruction – IN No. 8, of December 26, 2013, published in the Federal Official Journal No. 252, of December 30, 2013, Section 1, p. 758.”
