• For the ISO 13485 QMS, your organization will need to plan all of the processes that are involved with your product to ensure safe medical devices.
• You will need to define and classify the products so that   you know exactly what regulations apply to your medical device(s).
• Because of the specific focus of ISO 13485, an organization will need to be aware of certain definitions, regulations & classifications relevant to the Medical Device industry.

• Medical devices are listed, defined and classified in a variety of sources available through the Food and Drugs Administration and other Medical Devices Associations.
• General information relating to definitions, classifications and regulations for medical devices are provided from such sources.

See next slides

• A medical device is an object which is useful for diagnostic or therapeutic purposes.
• Examples of medical devices include medical thermometers, blood sugar meters, surgical sutures and x-ray machines.
• Depending on your location, you will need to know the applicable definitions:
  • USA
  • Canada
  • European
  • Others

Food & Drugs Act – Definition in USA

• A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or related article, including a component part, or accessory which is:
  • 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

… cont’d on next slide

Food & Drugs Act – Definition in USA – cont’d

• Intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of 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.

FDA – Classifications in USA 

• The FDA recognizes three classes of medical devices based on the level of control necessary to ensure the safety and effectiveness of the device.
• The classification procedures are described in the “Code of Federal Regulations (CFR), Title 21, part 820” (also known as 21 CFR 820).

Food & Drugs Act – Definition in Canada 

• The term Medical Devices covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition.

FDA – Classifications in Canada

• Health Canada reviews medical devices to assess their safety, effectiveness and quality before authorization for sale in Canada.
• 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.

European Definition 

A medical device is defined as:

• Any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of 

cont’d…

European Definition – cont’d

A medical device is defined as:

• A medical device is defined as any instrument .. intended to be used … 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

Class I: General Controls

• Class I devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices.
• These devices are subject only to general controls.

Class I: General Controls

• General controls cover such issues as manufacturer registration with the FDA, good manufacturing practices, proper labelling, notification of the FDA before marketing the device, and general reporting procedures.
• Devices in this category include tongue depressors, bedpans, elastic bandages, examination gloves, and hand-held surgical instruments and other similar types of common equipment.

Class II: General Controls with Special Controls

• Class II devices are those where general controls alone are insufficient to ensure safety and effectiveness, and additional existing methods are available to provide such assurances.
• Therefore, Class II devices are also subject to special controls in addition to the general controls of Class I devices…

cont’d…

Class II: General Controls with Special Controls – cont’d

• Special controls may include special labeling requirements, mandatory performance standards, and postmarket surveillance.
• Devices in this class are typically non-invasive and   include x-ray machines, PACS, powered wheelchairs, infusion pumps, surgical drapes, surgical needles and suture material, and acupuncture needles.

Class III: General Controls and Premarket Approval

• A Class III device is one where insufficient information is available to ensure safety and effectiveness solely through the general or special controls sufficient for Class I or Class II devices.
• Such a device needs premarket approval, a scientific review to ensure the device’s safety and effectiveness, in addition to the general controls of Class I.

cont’d…

Class III: General Controls and Premarket Approval – cont’d

• Examples of Class III devices which require a premarket approval include replacement heart valves, silicone gel-filled breast implants, implanted cerebral stimulators, implantable pacemaker, pulse generators and endosseous (intra-bone) implants (with the exception of root-form endosseous dental implants which are reclassified as Class II).

• Canada has 4 classifications:
  • Class I, II, III, IV
• In Europe and Australia:
  • Class I, IIa, IIb & III
• In the absence of specific regulations and classifications, the 21 CFR 820 can be applied in any location.

Note that the title for the ISO 13485 standard is:

Medical devices – Quality management systems – Requirements for regulatory purposes.

• With your medical devices defined and classified, you are closer to identifying the regulations that apply.  However, you need to research the relevant regulations. 

• Regulations can exist in several forms such as:
  • those specific to the activity
  • those specific to the products or services
  • those specific to the industry
• Regulations result mainly from regulators such as the Food and Drugs Administration, and others …
• Regulations are country/economic group dependent, unique to:
  • US, Canada, and European Regulations, among others

In the USA, typical regulations are available from:

• USA FDA Regulations – www.fda.gov/cdrh
• Code of Federal Regulations – Title 21, part 820 (aka CFR 21 Part 820)

In Canada, typical regulations are available from:

• Health Canada – www.hc-sc.gc.ca
• The Medical Devices Bureau of Health Canada 
• Canadian FDA Regulations 

Other regulations are available from:

• UK
  • The Medicines and Healthcare products Regulatory Agency (MHRA) 
• AU
  • Australian Government Department of Health 
• And many more in Europe…

These tools will help you reach certification:

• ISO 13485 Gap Analysis Checklist
• ISO 13485 Quality Manuals & Procedures Package
• ISO 13485 Internal Audit Checklist
• ISO 13485 All-in-One Package – our most popular product, and the best value!

For more information please feel free to contact us!