Risk classification (U.S. FDA product code BZS), a popular Class I medical device as determined by the U.S. FDA, ubiquitous in hospitals. The regulatory authorities recognize different classes of medical devices based on their potential for harm if misused, design complexity, and their use characteristics. Each country or region defines these categories in different ways. The authorities also recognize that some devices are provided in combination with drugs, and regulation of these
combination products takes this factor into consideration. Classifying medical devices based on their risk is essential for maintaining patient and staff safety while simultaneously facilitating the marketing of medical products. By establishing different risk classifications, lower risk devices, for example, a stethoscope or tongue depressor, are not required to undergo the same level of testing that higher risk devices such as artificial pacemakers undergo. Establishing a hierarchy of risk classification allows regulatory bodies to provide flexibility when reviewing medical devices.
Classification by region United States Under the
Food, Drug, and Cosmetic Act, the U.S.
Food and Drug Administration recognizes three classes of medical devices, based on the level of control necessary to assure safety and effectiveness. • Class I • Class II • Class III The classification procedures are described in the
Code of Federal Regulations, Title 21, part 860 (usually known as 21 CFR 860). Class I devices are subject to the least regulatory control and are not intended to help support or sustain life or be substantially important in preventing impairment to human health, and may not present an unreasonable risk of illness or injury. Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments. Class II devices are subject to special labeling requirements, mandatory performance standards and
postmarket surveillance. Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury and require
premarket approval.
Class I Devices: Non-invasive, everyday devices or equipment. Class I devices are generally low risk and can include bandages, compression hosiery, or walking aids. Such devices require only for the manufacturer to complete a Technical File.
Class Is Devices: Class Is devices are similarly non-invasive devices, however this sub-group extends to include sterile devices. Examples of Class Is devices include stethoscopes, examination gloves, colostomy bags, or oxygen masks. These devices also require a technical file, with the added requirement of an application to a European Notified Body for certification of manufacturing in conjunction with sterility standards.
Class Im Devices: This refers chiefly to similarly low-risk measuring devices. Included in this category are: thermometers, droppers, and non-invasive blood pressure measuring devices. Once again the manufacturer must provide a technical file and be certified by a European Notified Body for manufacturing in accordance with metrology regulations.
Class Ir Devices: Reusable surgical instruments include devices like ophthalmic scissors or needle holders. Under the
MDR, a manufacturer of Class Ir devices must be certified by a Notified Body with regard to reusability aspects.
Class IIa Devices: Class IIa devices generally constitute low to medium risk and pertain mainly to devices installed within the body in the short term. Class IIa devices are those which are installed within the body for only between 60 minutes and 30 days. Examples include hearing-aids, blood transfusion tubes, and catheters. Requirements include technical files and a conformity test carried out by a European Notified Body.
Class IIb Devices: Slightly more complex than IIa devices, class IIb devices are generally medium to high risk and will often be devices installed within the body for periods of 30 days or longer. Examples include ventilators and intensive care monitoring equipment. Identical compliance route to Class IIa devices with an added requirement of a device type examination by a Notified Body. Note: Some parts of the regulations differentiate between Class IIb and Class IIb
implantable devices, that is, some rules of the MDR apply specifically to Class IIb implantable and Class III devices, e.g. Article 52 paragraph 4 of the MDR.
Class III Devices: Class III devices are strictly high risk devices. Examples include balloon catheters, prosthetic heart valves, pacemakers, etc. The steps to approval here include a full quality assurance system audit, along with examination of both the device's design and the device itself by a European Notified Body. The authorization of medical devices is guaranteed by a Declaration of Conformity. This declaration is issued by the manufacturer itself, but for products in Class Is, Im, Ir, IIa, IIb or III, it must be verified by a
Certificate of Conformity issued by a
Notified Body. A Notified Body is a public or private organisation that has been accredited to validate the compliance of the device to the European Directive. Medical devices that pertain to class I (on condition they do not require sterilization or do not measure a function) can be marketed purely by self-certification. The European classification depends on rules that involve the medical device's duration of body contact, invasive character, use of an energy source, effect on the central circulation or nervous system, diagnostic impact, or incorporation of a medicinal product. Certified medical devices should have the
CE mark on the packaging, insert leaflets, etc.. These packagings should also show harmonised pictograms and
EN standardised logos to indicate essential features such as instructions for use, expiry date, manufacturer, sterile, do not reuse, etc. In November 2018, the
Federal Administrative Court of Switzerland decided that the "Sympto" app, used to analyze a woman's menstrual cycle, was a medical device because it calculates a fertility window for each woman using personal data. The manufacturer, Sympto-Therm Foundation, argued that this was a didactic, not a medical process. the court laid down that an
app is a medical device if it is to be used for any of the medical purposes provided by law, and creates or modifies health information by calculations or comparison, providing information about an individual patient.
Japan Medical devices (excluding in vitro diagnostics) in Japan are classified into four classes based on risk:
Rest of the world For the remaining regions in the world, the risk classifications are generally similar to the United States, European Union, and Japan or are a variant combining two or more of the three countries' risk classifications.
ASEAN The
ASEAN Medical Device Directive (AMDD) has been adopted by several southeast Asian countries. The nations are at varying stages of adopting and implementing the Directive. The AMDD classification is risk-based and defines four levels: A - Low Risk, B - Low to Moderate Risk, C - Moderate – High Risk, and D - High Risk.
Australia The classification of medical devices in Australia is outlined in section 41BD of the Therapeutic Goods Act 1989 and Regulation 3.2 of the Therapeutic Goods Regulations 2002, under control of the
Therapeutic Goods Administration. Similarly to the EU classification, they rank in several categories, by order of increasing risk and associated required level of control. Various rules identify the device's category
Canada s wait to be used at the
York Region EMS logistics headquarters in
Ontario The Medical Devices Bureau of
Health Canada recognizes four classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device. Class I devices present the lowest potential risk and do not require a licence. Class II devices require the manufacturer's declaration of device safety and effectiveness, whereas Class III and IV devices present a greater potential risk and are subject to in-depth scrutiny. • Class I (Canada) generally corresponds to Class I (ECD) • Class II (Canada) generally corresponds to Class IIa (ECD) • Class III (Canada) generally corresponds to Class IIb (ECD) • Class IV (Canada) generally corresponds to Class III (ECD) Examples include surgical instruments (Class I), contact lenses and ultrasound scanners (Class II), orthopedic implants and
hemodialysis machines (Class III), and
cardiac pacemakers (Class IV).
India Medical devices in India are regulated by Central Drugs Standard Control Organisation (
CDSCO). Medical devices under the Medical Devices Rules, 2017 are classified as per Global Harmonization Task Force (GHTF) based on associated risks. The CDSCO classifications of medical devices govern alongside the regulatory approval and registration by the CDSCO is under the DCGI. Every single medical device in India pursues a regulatory framework that depends on the drug guidelines under the Drug and Cosmetics Act (1940) and the Drugs and Cosmetics runs under 1945. CDSCO classification for medical devices has a set of risk classifications for numerous products planned for notification and guidelines as medical devices.
Iran Iran produces about 2,000 types of medical devices and medical supplies, such as appliances, dental supplies, disposable sterile medical items, laboratory machines, various biomaterials and dental implants. 400 Medical products are produced at the C and D risk class with all of them licensed by the Iranian Health Ministry in terms of safety and performance based on EU-standards. Some Iranian medical devices are produced according to the
European Union standards. Some producers in Iran export medical devices and supplies which adhere to
European Union standards to applicant countries, including 40 Asian and European countries. Some Iranian producers export their products to foreign countries.
United Kingdom Following
Brexit, the UK medical device regulation was closely aligned with the EU medical device regulation, including classification. The regulation 7 of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK medical devices regulations), classified general medical devices into four classes of increasing levels of risk: Class I, IIa, IIb or III in accordance with criteria in the UK medical devices regulations, Annex IX (as modified by Schedule 2A to the UK medical devices regulations).
Validation and verification Validation and verification of medical devices ensure that they fulfil their intended purpose.
Validation or verification is generally needed when a health facility acquires a new device to perform
medical tests. The main difference between the two is that validation is focused on ensuring that the device meets the needs and requirements of its intended users and the intended use environment, whereas verification is focused on ensuring that the device meets its specified design requirements.
Standardization and regulatory concerns The
ISO standards for medical devices are covered by ICS 11.100.20 and 11.040.01. The quality and
risk management regarding the topic for regulatory purposes is convened by
ISO 13485 and
ISO 14971. ISO 13485:2016 is applicable to all providers and manufacturers of medical devices, components, contract services and distributors of medical devices. The standard is the basis for
regulatory compliance in local markets, and most export markets. Additionally,
ISO 9001:2008 sets precedence because it signifies that a company engages in the creation of new products. It requires that the development of manufactured products have an approval process and a set of rigorous quality standards and development records before the product is distributed. Further standards are
IEC 60601-1 which is for electrical devices (mains-powered as well as battery powered),
EN 45502-1 which is for Active implantable medical devices, and
IEC 62304 for medical software. The
US FDA also published a series of guidances for industry regarding this topic against
21 CFR 820 Subchapter H—Medical Devices. Subpart B includes quality system requirements, an important component of which are
design controls (21 CFR 820.30). To meet the demands of these industry regulation standards, a growing number of medical device distributors are putting the complaint management process at the forefront of their
quality management practices. This approach further mitigates risks and increases visibility of quality issues. Starting in the late 1980s, the FDA increased its involvement in reviewing the development of medical device software. The precipitant for change was a radiation therapy device (
Therac-25) that overdosed patients because of software coding errors. FDA is now focused on regulatory oversight on medical device software development process and system-level testing. A 2011 study by Dr.
Diana Zuckerman and Paul Brown of the
National Center for Health Research, and
Dr. Steven Nissen of the
Cleveland Clinic, published in the
Archives of Internal Medicine, showed that most medical devices recalled in the last five years for "serious health problems or death" had been previously approved by the FDA using the less stringent, and cheaper, 510(k) process. In a few cases, the devices had been deemed so low-risk that they did not they did not undergo any FDA regulatory review. Of the 113 devices recalled, 35 were for cardiovascular issues. This study was the topic of Congressional hearings re-evaluating FDA procedures and oversight. A 2014 study by Dr.
Diana Zuckerman, Paul Brown, and Dr. Aditi Das of the
National Center for Health Research, published in JAMA Internal Medicine, examined the scientific evidence that is publicly available about medical implants that were cleared by the FDA 510(k) process from 2008 to 2012. They found that scientific evidence supporting "substantial equivalence" to other devices already on the market was required by law to be publicly available, but the information was available for only 16% of the randomly selected implants, and only 10% provided clinical data. Of the more than 1,100 predicate implants that the new implants were substantially equivalent to, only 3% had any publicly available scientific evidence, and only 1% had clinical evidence of safety or effectiveness. The researchers concluded that publicly available scientific evidence on implants was needed to protect the public health. In 2014–2015, a new international agreement, the Medical Device Single Audit Program (MDSAP), was put in place with five participant countries: Australia, Brazil, Canada, Japan, and the United States. The aim of this program was to "develop a process that allows a single audit, or inspection to ensure the medical device regulatory requirements for all five countries are satisfied". In 2017, a study by Dr. Jay Ronquillo and
Dr. Diana Zuckerman published in the peer-reviewed policy journal Milbank Quarterly found that electronic health records and other device software were recalled due to life-threatening flaws. The article pointed out the lack of safeguards against hacking and other cybersecurity threats, stating "current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market". They added that legislative changes resulting from the law entitled the 21st Century Cures Act "will further deregulate health IT, reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients". A study by Dr. Stephanie Fox-Rawlings and colleagues at the National Center for Health Research, published in 2018 in the policy journal Milbank Quarterly, investigated whether studies reviewed by the FDA for high-risk medical devices are proven safe and effective for women, minorities, or patients over 65 years of age. The law encourages patient diversity in clinical trials submitted to the FDA for review, but does not require it. The study determined that most high-risk medical devices are not tested and analyzed to ensure that they are safe and effective for all major demographic groups, particularly racial and ethnic minorities and people over 65. Therefore, they do not provide information about safety or effectiveness that would help patients and physicians make well informed decisions. In 2018, an investigation involving journalists across 36 countries coordinated by the
International Consortium of Investigative Journalists (ICIJ) prompted calls for reform in the United States, particularly around the 510(k)
substantial equivalence process; the investigation prompted similar calls in the UK and Europe Union.
Packaging standards Medical device
packaging is highly regulated. Often medical devices and products are sterilized in the package. Sterility must be maintained throughout distribution to allow immediate use by physicians. A series of special
packaging tests measure the ability of the package to maintain sterility. Relevant standards include: • ASTM F2097 –
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products • ASTM F2475-11 – Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials • EN 868
Packaging materials and systems for medical devices to be sterilized, General requirements and test methods • ISO 11607
Packaging for terminally sterilized medical devices Package testing is part of a
quality management system including
verification and validation. It is important to document and ensure that packages meet regulations and end-use requirements. Manufacturing processes must be controlled and validated to ensure consistent performance. EN ISO 15223-1 defines symbols that can be used to convey important information on packaging and labeling.
Biocompatibility standards •
ISO 10993 - Biological Evaluation of Medical Devices
Cleanliness standards Medical device cleanliness has come under greater scrutiny since 2000, when Sulzer Orthopedics recalled several thousand metal hip implants that contained a manufacturing residue. Based on this event, ASTM established a new task group (F04.15.17) for established test methods, guidance documents, and other standards to address cleanliness of medical devices. This task group has issued two standards for permanent implants to date: 1. ASTM F2459: Standard test method for extracting residue from metallic medical components and quantifying via gravimetric analysis 2. ASTM F2847: Standard Practice for Reporting and Assessment of Residues on Single Use Implants 3. ASTM F3172: Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices In addition, the cleanliness of re-usable devices has led to a series of standards, including: • ASTM E2314:
Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)" • ASTM D7225:
Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors • ASTM F3208:
Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices Additionally, the FDA is establishing new guidelines for reprocessing reusable medical devices, such as orthoscopic shavers, endoscopes, and suction tubes. New research was published in
ACS Applied Interfaces and Material to keep Medical Tools pathogen free.
Safety standards ==Design, prototyping, and product development==