Testing Standard Requirements around the World

Testing Standard Requirements around the World

Medical device testing- an overview

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.

Canada’s list of Recognized Standards for Medical Devices mentions a combination of ISO and ATSM standards. For electromedical compatibility, it accepts CSA standards.

Australia accepts the list of standards referenced in  Conformity Assessment Standard Orders (CASO) and Medical Device Standard Orders (MDSO). It is not mandatory but conformance to these standards are recommended.

FAQs

Why are testing standards important?

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.

Requirements of Technical Documentation EU MDR

Requirements of Technical Documentation EU MDR

Technical documentation should contain details of the medical device in a clear, organized, readily searchable and unambiguous manner. It should be provided with all medical devices irrespective of the device class and to be kept updated throughout the product life cycle. Technical documentation is to be prepared according to the requirements given in Annex II of EU MDR 2017/745.

Requirements as per Annex II

  1. Device description and specification, including variants and accessories
  2. Information to be supplied by the manufacturer
  3. Design and Manufacturing information
  4. General safety and performance requirements
  5. Benefit-risk analysis and risk management
  6. Product verification and validation

Device description and specification, including variants and accessories

This section mentions that technical documentation must include all basic device details such as trade name, general description, Basic UDI-DI, principles of operations, classification details, accessories description, key functional elements, technical specification etc. There must also be a proper reference to previous or similar medical devices.

Information to be supplied by the manufacturer

This section mentions that manufacturer must include a complete set of labelling for the device and its packaging. The manufacturer must also ensure the language requirements of the same according to the each member states’ language requirements.

Design and Manufacturing information

This section mentions that the technical documentation shall include complete information on processes carried out by the manufacturer during the design stage, manufacturing, validation, monitoring and final product testing of the device. Identification details of all sites and people involved in the manufacturing process must also be made available.

General safety and performance requirements

This section mentions that the technical documentation must demonstrate conformity to general safety and performance requirements set out in Annex I of the MDR. This shall include details such as an explanation for safety and performance requirements that the device satisfies and an explanation for requirements that it does not meet, methods used to demonstrate conformity, harmonized standards, Common specifications, and the identity information of the control documents.

Benefit-risk analysis and risk management

This section mentions that the technical documentation shall include the benefit-risk analysis, solutions adopted, and risk management results as per Annex I of the MDR. Some significant points from the Risk management section of Annex I are

  • The risk management plan must be available for each device
  • Should be able to identify foreseeable hazards associated with each device
  • should be able to estimate and evaluate the risks
  • should have plans to eliminate/control the risks
  • should be able to assess the impact of risk at various stages of the device’s lifecycle and thereby estimating overall risk, benefit-risk ratio, and risk acceptability

Section 1 to 8 of Annex I gives detailed information on general safety measures and other risk management requirements.

Product verification and validation

This section mentions that the technical documentation shall contain results and critical analyses of all verification and validation tests/studies. Some significant Tests/studies discussed in the section are

  • Biocompatibility
  • Electrical Safety
  • Electromagnetic compatibility
  • Software verification and validation
  • Stability
  • Performance and Safety
  • Physical, chemical, and microbiological characteristics
  • sterility

A clinical evaluation report and a PMCF (Post-market clinical follow-up) plan and evaluation report must be available. Else, a justification for why PMCF is not applicable must be made available. Additional information required in specific cases is given in detail in Section 6.2 of Annex II of the EU MDR.

Post-Market Surveillance

Annex III of the MDR majorly mentions that the post-market surveillance plan must address the method of collection and utilization of available data (Such as information on serious incidents and their corrective actions, data on any undesirable side- effects and so on) and includes a list of details a post-market surveillance plan must include in the plan. There is also a reference to PSUR (Periodic safety update report) and post-market surveillance report mentioned in articles 86 & 85, respectively.

Significant Changes to be noted during the transition from MDD to MDR

  1. Device description to include UDI, UDI-DI or any such number for traceability reasons
  2. Reference requirements to previous or similar medical devices
  3. Under labelling requirements in the MDR, it is explicitly talks about the labelling of devices and their packaging
  4. Language requirements for labelling
  5. As per the MDD, only Class III devices required an explanation for design stages and procedures. The same is now updated to all classes of medical devices in MDR
  6. Identification requirements of all manufacturing sites, design including suppliers and contractors are required now
  7. General safety and performance requirements are updated versions of Essential requirements from the MDD
  8. The benefit-risk analysis is explicitly mentioned as part of risk management requirements in the MDR
  9. Product verification and validation requirements
  10. A detailed explanation of pre-clinical and evaluation and Clinical Evaluation requirements are provided in the MDR
  11. The requirements of the Clinical Evaluation plan and report, Post-market clinical follow-up plan and report are specially mentioned in the MDR
  12. Additional information for special case devices (e.g., combination device, sterile device, device with measuring function etc.) is mentioned in detail in the MDR

FAQs:

What are Common specifications?

Common Specifications are a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.

What is the UDI?

The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It allows the unambiguous identification of a specific medical device on the market. The UDI is comprised of the UDI-DI and UDI-PI. The unique identifier may include information on the lot or serial number and be able to be applied anywhere
in the world.

What is the Basic UDI-DI?

Basic UDI-DI is intended to identify and connect devices with the same intended purpose, risk class and essential design and manufacturing characteristics. It is independent/separate from the packaging/labelling of the device and it does not appear on any trade item

Is Post-market surveillance (PMS) applicable for only higher risk classes?

PMS is required for all device classes. A PMS plan and report to be maintained and kept updated by the manufacturer throughout the device life cycle.


Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.

Exceptional Use Medical Devices in the EU and UK

Exceptional Use Medical Devices in the EU and UK

Medical devices conforming with the medical device regulations must have a conformity marking. Medical devices that do not conform may still be placed in the market, provided they apply through the exceptional use devices pathway. This article discusses the exceptional use requirements to be satisfied to gain access to EU and UK markets.

In the UK, the UKCA marking displays that the device conforms to UK Medical Device Regulations 2002. Without UKCA marking, the devices can only be placed in the market under certain circumstances. Similarly, CE marking is accepted throughout the EU, which denotes that medical device conforms to the EU MDR 2017/745. This procedure may also apply to custom-made devices that have not complied with standard conformity procedures. These devices are called special-purpose devices in the EU and are mentioned in Article 21 of EU MDR 2017/745.

Exceptional devices in the UK

Medicines and Healthcare products Regulatory Agency (MHRA) regulates medical devices as per UK MDR 2002. The MHRA may authorise non-compliant devices, but this is done on a case-by-case basis.

A manufacturer may place a medical device if the following conditions are met:

  • The clinician supports the application for the treatment of the patient
  • No alternative to this medical device is available on the market
  • Justification on how the medical device can improve the patient’s health with the device

The manufacturer is responsible for placing the device on the market, but the manufacturer and clinician must fill out the Humanitarian use of device-application form and submit to [email protected] . The application form must be submitted for each different patient. MHRA approves the case-by-case application basis and may request more information if the application details are deemed unclear.

The application form for exceptional use devices requires the following details:

  • Name and address of the manufacturer
  • Generic name of the device
  • Clinical investigation details
  • Risk analysis, hazard identification and estimation of risks
  • Name and address of the consultant
  • Patient’s medical condition details
  • Device necessity and
  • Other relevant information  

Devices for special purposes in the EU

Devices under this category do not require a CE mark. Still, they must meet the conditions mentioned in EU MDR that the device is evaluated for its safety and effectiveness by the manufacturer. Articles 62-82 of EU MDR describe the requirements to be met by manufacturers of investigational devices.

Firstly, for investigational devices, a proper clinical investigation plan is required. Read our detailed article on Clinical investigation in the EU for more information regarding this topic. In short, the clinical investigation has a different technical file and application form than the CE-marked medical devices.

The application form should be submitted with the following documents.

  • Clinical investigation plan
  • Investigator’s brochure
  • Name and address of the manufacturer
  • Patient information sheet
  • Detailed risk analysis and test reports
  • Informed consent document
  • Other available technical documentation

Custom-made devices

As per EU MDR, ‘custom-made devices’ means as any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person’s professional qualifications which gives, under that person’s responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their conditions and needs. However, the definition does not include ‘mass produced’ devices that need to be adjusted per user requirements. UK MDR 2002 5 (1) has a similar definition for custom-made medical devices. The provisions in Great Britain (England, Wales and Scotland) can be accessed in Guidance on Custom-made devices in GB. Medical devices like dental appliances and prosthetics all come under custom-made devices as these are designed specifically for an individual and are not mass-produced.

Custom-made devices require technical documentation following Annex II and III of EU MDR. In addition to the documents, the manufacturer or authorised representative should draw a statement containing crucial information like that the device is intended for exclusive use by a particular user and data allowing unique identification of the medical device.

An important point to remember is that custom-made devices must conform to general safety and performance requirements in Annex I of EU MDR and essential requirements in Annex I Schedule 2A of the UK MDR 2002, and the devices are not exempt from these requirements.

FAQs

What devices come under custom-made devices?

Medical devices that come under Custom-made devices are specifically designed for an individual patient. Some great examples include dental crowns, fillings, elastics and retainers for dental structure or health. Other devices such as artificial eyes and maxillofacial implants like craniofacial implants, auricular, nasal implants, hearing aids and orthopaedic footwear fall into this category. The healthcare professionals must take accurate impressions of patients so that the device is a custom fit for the end-user or patient.

What is the difference between a custom-made device and an investigational device?

Investigational devices are those that are research devices that are developed that have no market equivalent. These devices are subjected to a clinical study to check product effectiveness. On the other hand, custom-made devices are not subject to clinical research but are customised according to the patient’s requirements. Both investigational devices and custom-made devices do not require CE/UKCA marking and require exceptional devices regulatory approvals to enter the respective markets.


Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.

Smart Wearables Regulations in the EU 

Smart Wearables Regulations in the EU 

The booming technological aspects have constantly challenged regulations established worldwide in the modern century because the regulations either inadequately govern novel technologies, or there always exists a scenario where the devices cannot be categorized within a given regulation. Smart wearables are one of those aspects falling into such debate in recent times. Days are no longer from the fact that these smart wearables may draw strict regulations to be in place.

How are these general wellness devices regulated? What are these devices classified as?

Unlike medical devices, these devices are intended to be used for wellness reasons such as to improve the lifestyle by monitoring the user’s diet and exercise, enhancing physical activity etc., and they are ideally not intended to get involved in any diagnosis or therapy.

Intended Use

Any device is subject to a regulation based on its “intended use” declared by the manufacturer. Hence the manufacturer needs to pay utmost attention in declaring what their device supposed is to be used for real-life scenarios. Smart wearables are often confused with medical devices, or sometimes they are by mistake considered medical devices if a vague intended use statement is written for the device.

Generally, smart wearables are low-powered electronic equipment intended to be worn by the user, such as wrist-worn, neckband, body-worn, adhesive to the skin surface to collect some data and transfer the information to a mobile device application.

Sensors and electronic components present in your smart wearables monitor your activities which could be determining the body’s orientation, climbing stairs, speed of walking or running, heartbeat, oxygen levels, respiratory rate, sleep patterns, etc. Now the question here is, should one consider this a medical device when the device monitors HR, SpO2, and respiratory rates, which a physician usually monitors to determine the state of health and use these data to diagnose any physiological condition.

The answer is not straightforward, but there are smart wearables in the market that obtain FDA clearance that claims to perform certain medical purposes as the intended purpose. Such devices fall under the medical device category.

Hence, if the manufacturer claims that the device has a “medical purpose” in its intended use, the device falls under a medical device. Claims are critical in these cases.

How is my smart wearable regulated?

In Europe, there is no separate regulation released to date for smart wearables; however, depending on the nature of your device, it is mandatory to adhere to the applicable EU directive or EU Regulation. CE marking is mandatory for all categories of equipment entering the EU market.

It is essential to identify the applicable regulations for the device based on the nature and functionality of the equipment. For any electronic radio equipment, the following EU directives apply

· Radio Equipment Directive 2014/53/EU

· EMC Directive 2014/30/EU

· Low Voltage Directive 2014/35/EU

· RoHS and REACH Directive 2011/65/EU

· WEEE Directive 2002/92/EC

The below tables give a quick brief of key requirements applicable across the directives and this list is non-exhaustive:

SectionsRadio Equipment DirectiveEMC DirectiveLow Voltage DirectiveRoHS and REACH
Essential RequirementsArticle 3Article 6 Annex ISafety Objectives -Annex IArticle 4, Annex II Prevention
Technical DocumentationArticle 21 Annex VAnnex II or IIIAnnex IIIArticle 6 Review of Restricted Substances
Conformity AssessmentArticle 17, Annex II or III or IV  Article 14, Annex II or IIIAnnex IIINot applicable
Obligations for Economic Operators*ApplicableApplicableApplicableApplicable
EU DoCArticle 18 Annex VIArticle 15 Annex IVArticle 15, Annex IV &  Module A of Annex IIIArticle 13, Annex VI
Simplified DoCArticle 18 Annex VIINot applicableNot applicableNot applicable
Field Corrective measuresApplicableApplicableApplicableApplicable

*-Economic Operators consists of Manufactures, Authorised Representatives, Distributors and Importers

The above listed are very few directives applicable for a low-powered electronic radio equipment category of the smart wearable device. It is the manufacturer’s responsibility to identify relevant regulations suitable for the device and adopt the same to meet product compliance.

The directives and standards differ based on the type of devices, such as IT and telecommunication, digital, and audio/video radio equipment.

How to use Harmonized Standards to demonstrate compliance?

Harmonized standards are voluntary standards adopted by the EU commission and deemed acceptable to demonstrate product compliance. It is presumed that by adopting harmonized standards published by the EU commission for those directives, the manufacturer can claim product compliance to the respective directive.

The standards adopted for design and testing should comprise safety and functional performance relevant to the devices. It also must meet the essential requirements of the directives/regulations.

Accredited Laboratory Testing

Testing is an integral part of demonstrating product compliance. It is always advisable to approach an accredited third-party laboratory to perform the applicable tests for your product. Manufacturers’ internal test reports are rarely considered for compliance or sometimes a risky element to showcase such reports.

Significance of Technical Documentation

As stated above, RED, EMC and LVD directives mandate the manufacturer to maintain technical documentation of the product with a retention period of 10 years from placing the device on the market. 

Instructions for Use (IFU) and Labelling

Manufacturers are obliged to supply adequate information on the device’s safe usage and the device. The accompanied instruction and safety information must be in a language that can be easily understood by the user and be in the official languages of the member states. The safety information of device interference characteristics must be disclosed for radio equipment that intentionally emits radio waves.

Declaration of Conformity

The manufacturer must provide the DoC with each device sold in the market, and it needs to be in the official language of the member states. In cases where more than one directive or regulation is applied to the device, the contents of the DoC must include all the elements listed in each of those directives. In certain directives, a simplified DoC is also required to be mentioned in the IFU, where it states the location of the updated DoC on the manufacturer’s website.

Conclusion

Regulations in recent years are becoming increasingly stringent towards safety. As these devices bring in more advancements and are closely engaged with the human lifestyle to promote health and wellness, there must be careful consideration in bordering these products from being falling into the medical devices category. Eventually, be it a medical device or any equipment, it is the ultimate responsibility of the manufacturer to produce safe products.

FAQs

Does the EU maintain a list of harmonized standards?

The EU Commission maintains a list of harmonized standards published on their official website, which is updated on a timely basis.
https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en

How does the EU regulate Data protection and privacy of the data?

General Data Protection Regulation applies to devices that collect and process the users’ personal data. European Union has sought to ensure the protection of this right through legislation. The vital regulatory principles of this GDPR are data protection principles, accountability, Data security, Data protection by design, consent, and people’s privacy rights.

Does US FDA have any regulation on smart wearable technologies?

FDA does not regulate general wellness devices, but it has released general guidance on the “general wellness: policy for low-risk devices” to provide clarity to industry and FDA staff on the Center for Devices and Radiological Health’s (CDRH’s) compliance policy for low-risk products that promote a healthy lifestyle.


Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.

Global Labelling Requirements

Global Labelling Requirements

Label, Labelling vs Instructions for Use (IFU)?

  • 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 NumberStandard Name
ISO 18113  In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 1, 2, 3, 4 and 5
ISO 28219Packaging – Labelling and direct product marking with linear bar code and two-dimensional symbols
ISO 15223  Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1 and 2
ISO 3864  Graphical symbols – Safety colours and safety signs – Part 1, 2, 3
ISO 20417Medical devices – Information to be supplied by the manufacturer
ISO 14025Environmental labels and declarations – Type III environmental declarations – Principles and procedures
ISO 14021Environmental labels and declarations – Self-declared environmental claims (Type II environmental labelling)
ISO 14020Environmental labels and declarations – General principles
ISO 22742Packaging – 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.

Global ISO Requirements

Global ISO Requirements

What is ISO?

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 2019 which provides a list of applicable conformity assessment standards.
  • Brazil’s ANVISA accepts Good Manufacturing Practices (GMP) along with the ISO 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.