Risk classification guide for medical device establishment inspections (GUI-0079): Sample observations and ratings

On this page

• Food and Drugs Act
• Medical Devices Regulations, Part 1, General
• MDR, Part 2, Custom-made devices and medical devices to be imported or sold for special access
• MDR, Part 3, Medical devices for investigational testing involving human subjects
• MDR, Part 4, Export certificates

The following sample observations may be noted by inspectors when there are violations related to the Food and Drugs Act (FDA) and Medical Devices Regulations (MDR). This is not a complete list. Inspectors may use other observations where needed.

The full text of the Food and Drugs Act and the full text of the Medical Devices Regulations are available on the Department of Justice Web site.

At the inspector's discretion, the observations are ranked as Risk 1, 2 or 3 and may be escalated (for example, if it's a repeat observation).

Food and Drugs Act

Section 3 General (advertising)

Risk 2 (major) observations

• FDA s.3(1): Advertisements to the general public claimed a device is a treatment, prevention, cure for diseases, disorders, abnormal physical states prohibited in Schedule A.1.
  • This prohibition applies to both paper and electronic formats.
• FDA s.3(2)(a): A device with a Schedule A.1 claim on the label was offered for sale.
• FDA s.3(2)(b): A device advertised to the public with a Schedule A.1 claim was offered for sale.
• FDA s.3(3): A contraceptive device was advertised to the general public.
  • Section 24 of the MDR allows some advertising of contraceptive devices, but not intrauterine devices.

Sections 19 to 21 Devices

Risk 1 (critical) observations

• FDA s.19: A device was sold that, when used as directed, may cause injury to the health of the buyer or user.
• FDA s.20(1): The company was labelling, packaging, treating, processing, selling and/or advertising devices in a way that was likely to create an incorrect impression about their design, construction, performance, intended use, quantity, character, value, composition, merit and/or safety, which presented a significant risk to health and safety.
• FDA s.21: A device was labelled, packaged, sold or advertised in a way that did not meet prescribed standards and presented a significant risk to health and safety.

Risk 2 (major) observations

• FDA s.20(1): The company was labelling, packaging, treating, processing, selling and/or advertising devices in a way that was likely to create an incorrect impression about their design, construction, performance, intended use, quantity, character, value, composition, merit and/or safety.
• FDA s.20(1): Expired medical devices were available for sale.
• FDA s.20(1): The company was conducting manufacturing activities it was not authorized to perform.
• FDA s.21: A device was labelled, packaged, sold or advertised in a way that did not meet prescribed standards.

Sections 37 to 38 Exports

Risk 2 (major) observations

• FDA s.37: The requirements for an export certificate were not met. (Evaluate under sections 89 to 92 of the MDR.)

Medical Devices Regulations, Part 1, General

Section 9 Manufacturer's obligations

Risk 1 (critical) observations

• MDR s.9(1): Devices did not meet safety and effectiveness requirements (listed in sections 10 to 20) and may present a significant risk to health and safety.
• MDR s.9(2): Records proving safety and effectiveness were missing, which poses a significant risk to health and safety.

Risk 2 (major) observations

• MDR s.9(1): Devices did not meet safety and effectiveness requirements listed in sections 10 to 20.
• MDR s.9(2): Records proving safety and effectiveness were incomplete.

Sections 10 to 20 Safety and effectiveness

Risk 1 (critical) observations

• MDR s.10 to 20: Safety and effectiveness requirements for the design, manufacture, characteristics, performance and use of device were not met, and the device presents a significant risk to health and safety.

Risk 2 (major) observations

• MDR s.10 to 20: Safety and effectiveness requirements for the design, manufacture, characteristics, performance and use of device were not met.

Sections 21 to 23 Labelling

Risk 1 (critical) observations

• MDR s.21(1)(h): Device label did not describe purpose or intended use, which poses a significant risk to health and safety.
• MDR s.21(1)(i): Device label did not have directions for safe and effective use, which presents a significant risk to health and safety.

Risk 2 (major) observations

• MDR s.21(1) to 23(3): There were multiple labelling deficiencies. (Apply highest risk rating based on which requirements are missing.)
• MDR s.21(1): Devices available for sale had no label.
• MDR s.21(1): Devices available for sale were improperly labelled.
• MDR s.21(1)(a): Labels on devices available for sale had an incorrect name or were missing the name of the device.
• MDR s.21(1)(b): Labels on devices available for sale had the incorrect manufacturer's name and/or address or were missing the manufacturer's name and/or address.
• MDR s.21(1)(c): Labels on devices available for sale did not have device identifiers or had incorrect device identifiers. (If device is unlicensed, assess under section 26 of the MDR.)
• MDR s.21(1)(d): Labels on Class III or IV devices available for sale did not have control numbers or had incorrect control numbers.
• MDR s.21(1)(e): Labels on devices available for sale did not clearly indicate the content of the package.
• MDR s.21(1)(f): Labels on devices sold in a sterile state did not say "Sterile". (Consider intended use of device and classification.)
• MDR s.21(1)(f): Labels on devices indicated "Sterile" while the content was not sterile. (Consider intended use of device and classification. Assess under section 20(1) of the FDA.)
• MDR s.21(1)(g): Labels on devices available for sale did not have expiry dates based on the shortest projected useful life.
• MDR s.21(1)(h): Labels on devices available for sale did not describe intended use.
• MDR s.21(1)(i): Labels on devices available for sale had inadequate or missing directions for use.
• MDR s.21(1)(j): Labels on devices available for sale did not include storage conditions. (Consider intended use of device and classification.)
• MDR s.21.1(b): Devices for which an advance notice of importation was issued were not re-labelled within 3 months of importation.
• MDR s.21.2: The importer did not ensure that the manufacturer notified the Minister of the name of the person responsible for re-labelling the device in Canada on their behalf.
• MDR s.21(2): The manufacturer could not be clearly identified because more than 1 company's name and address were on the label.
• MDR s.21(2): Labels on devices available for sale did not have the required information in a legible, permanent and/or prominent manner, in terms that are easily understood by the intended user. (If label is not at all legible, it is technically not a label. In that case, cite under subsection 21(1) of the regulations that device has no label.)
• MDR s.23(1): Labels on devices available for sale did not have the required information in either English or French.
• MDR s.23(2): Directions for use were not made available in the other official language upon request.
• MDR s.23(3): Labels on devices available for sale to the general public did not have the required information in both English and French.

Risk 3 (minor) observations

• MDR s.21(1) to 23(3): There were multiple labelling deficiencies. (Apply highest risk rating based on which requirements are missing.)
• MDR s.21(1)(e): Labels on devices available for sale did not list contents.
• MDR s.22(1)(a): Labels on devices available for sale to the general public did not show all required information on the outside of the package.
• MDR s.22(1)(b): Required information on device label was not visible.

Section 25 Class I medical devices

Risk 1 (critical) observations

• MDR s.25(2): The company received official notice to stop selling a Class I device and continued to sell.

Risk 2 (major) observations

• MDR s.25(2)(a): The company did not provide safety and effectiveness information upon request.

Sections 26 to 31 Class II, III and IV medical devices

Risk 1 (critical) observations

• MDR s.26: Devices not authorized for sale by Health Canada were sold by the company under any of the following conditions:
  • documented evidence shows unlicensed device (or devices) poses significant risk to health and safety
  • the number of unlicensed devices found presents a significant risk to health and safety
  • company received official notice to stop sale and continued to sell

Risk 2 (major) observations

• MDR s.26: Devices not authorized for sale by Health Canada were found available for sale. (If significant risk to health and safety, rate as Risk 1.)
• MDR s.27(a): The company advertised unlicensed devices.

Risk 3 (minor) observations

• MDR s.27(b): The warning in the catalogue (advertising material) that devices may not be licensed for sale in Canada was not clear or visible. (Consider intended use of device and classification. If higher risk devices, rate as Risk 2.)

Sections 44 to 51 Establishment licence

Risk 1 (critical) observations

• MDR s.44(1): The company imported and/or sold medical devices without an establishment licence. (Consider intended use of device, classification and whether establishment received official notice to stop import/sale.)
• MDR s.45(g): The company did not have any written procedures or processes in place for maintaining distribution records, complaint handling and recall.

Risk 2 (major) observations

• MDR s.44(1): The company imported and/or sold medical devices without an establishment licence. (Consider intended use of device and classification.)
• MDR s.44(3): The company imported from an unapproved source. (Source does not hold establishment licence and is not the manufacturer.)
• MDR s.45(c): The establishment licence application did not list all of the company's activities (import and/or distribute).
• MDR s.45(g): The company did not have written procedures in place or the procedures were inadequate for distribution records. (Evaluate processes/procedures and their implementation under sections 52 to 56 of the MDR.)
• MDR s.45(g): The company did not have written procedures in place for complaint handling. (Evaluate procedures and their implementation under sections 57 to 58 of the MDR.)
• MDR s.45(g): The company did not have written procedures in place for recalls. (Evaluate procedures and their implementation under sections 58 and63.1 to 65 of the MDR.)
• MDR s.45(h): The importer of Class I devices did not have written procedures in place or the procedures were inadequate for incident reporting. (Evaluate procedures and their implementation under sections 59 to 61 of the MDR.)
• MDR s.45(h.1): The importer of Class II, III or IV devices did not have written procedures in place, or the procedures were inadequate for incident reporting or provision of information related to risk. (Evaluate procedures and their implementation under sections 59 to 61, 61.2 and 61.3 of the MDR.)
• MDR s.45(i): The company did not have written procedures in place or the procedures were inadequate or not implemented for handling, storing, delivering, installing and/or servicing medical devices (if 1 or more procedures are missing or ineffective.)
• MDR s.48: The company did not notify Health Canada that it had changed its name and/or address or did not notify Health Canada within the required timeline.
• MDR s.48: The company did not notify Health Canada that the company representative name, title or contact information had changed.

Risk 3 (minor) observations

• MDR s.45(a): The establishment licence application did not include the company's correct name and address. (Assess under section 48 of the MDR.)
• MDR s.45(a.1): The establishment licence application did not include any other name under which the company previously conducted activities.
• MDR s.45(b): The establishment licence application did not include the correct name, title and contact information of the company's contact. (Assess under section 48 of the MDR.)
• MDR s.45(d): The name and address of manufacturers provided by the company on its establishment licence application were not accurate. (If numerous, rate as Risk 2.)
• MDR s.45(f): The classes of devices that were being imported and/or distributed did not match the information provided by the company on its establishment licence application.
• MDR s.45(g): The written procedure for distribution records was inadequate (missing minor elements but could still work). (Evaluate procedure and its implementation under sections 52 to 56 of the MDR. If missing important elements, rate as Risk 2.)
• MDR s.45(h): The written procedure for incident reporting (for Class I importer) was inadequate (missing minor elements but could still work). (If the procedure is completely missing or important elements are missing, rate as Risk 2.)
• MDR s.45(h.1): The written procedures for incident reporting and/or provision of information related to risk (for Class II, III or IV importer) were inadequate (missing minor elements but could still work). (If procedures are completely missing or important elements missing, rate as Risk 2.)
• MDR s.45(i): The written procedures for handling, storage, delivery, installing and/or servicing were inadequate (missing minor elements, but could still work). (If procedures are completely missing or important elements missing, rate as Risk 2.)
• MDR s.45(i): The company's implementation of procedures for handling, storage, delivery, installation, corrective action and/or servicing of medical devices was inadequate. (Consider device classification and risk associated with deficiency. If higher risk, rate as Risk 2.)
• MDR s.45(j): The company did not list the address of each building where procedures in paragraphs (g) to (i) were in place.
• MDR s.48: The company did not notify Health Canada within the required timeline that the company representative name, title and/or contact information had changed.

Sections 52 to 56 Distribution records

Risk 1 (critical) observations

• MDR s.52(1): The company did not maintain distribution records for its devices. (Most or all of records are missing.)
• MDR s.53: The company's distribution records did not have enough information to allow for a complete and rapid recall of device(s) from the marketplace. (Most or all of the records are missing information.)
• MDR s.54(1): The company's distribution records were missing the information received on the implant registration cards. (Most or all of the records are missing information.)
• MDR s.54(2): The company's distribution records had outdated implant registration information. (Most or all of the records had outdated information.)

Risk 2 (major) observations

• MDR s.52(1): The company did not maintain complete distribution records for some of its devices. (If most or all of the records are missing, rate as Risk 1.)
• MDR s.53: Some of the company's distribution records were missing information needed to allow for a complete and rapid recall of device(s) from the marketplace. (If most or all of the records are missing information, rate as Risk 1.)
• MDR s.54(1): Some of the company's distribution records were missing the information received on the implant registration cards. (If most or all of the records are missing information, rate as Risk 1.)
• MDR s.54(2): Some of the company's distribution records had outdated implant registration information. (If most or all of the records are missing information, rate as Risk 1.)
• MDR s.55: The company did not maintain distribution records for the required period of time.
• MDR s.56: Distribution records could not be retrieved in a timely manner.

Sections 57 to 58 Complaint handling

Risk 1 (critical) observations

• MDR s.57(1)(a): The company did not keep records of complaints.
• MDR s.58(a): The written procedure for complaint handling was inadequate or not implemented by the company. No or insufficient action taken in response to complaints to prevent risk. (Consider risk associated with the complaints and devices involved, if significant risk to health and safety, rate as Risk 1. If remote risk, rate as Risk 2.)
• MDR s.58(b): The written procedure for recalling devices was inadequate or not implemented by the company. Recall(s) not conducted, no records or recalls conducted are ineffective. (Consider risk associated with devices and recalls. If significant risk to health and safety, rate as Risk 1. If remote risk, rate as Risk 2.)

Risk 2 (major) observations

• MDR s.57(1)(a): The company could not provide a complete record of complaints. (If no records, rate as Risk 1.)
• MDR s.57(1)(b): The company could not provide a complete record to show it properly investigated a complaint about a device. (If no records, rate as Risk 1.)
• MDR s.58(a): The written procedure for handling complaints was inadequate or missing important elements. Procedure would be ineffective, or no procedure in place, but reported problems are being investigated. (If no action taken to prevent risk in response to complaints, rate as Risk 1.)
• MDR s.58(a): The written procedure for complaint handling was not implemented by the company. Insufficient action taken in response to complaints to prevent risk. (Consider risk associated with the complaints and devices involved. If significant risk to health and safety, rate as Risk 1.)
• MDR s.58(b): The written procedure for recalling devices was missing important elements or was inadequate. Procedure would be ineffective or no procedure in place, but recalls are being conducted. (If no records or significant risk to health and safety, rate as Risk 1.)
• MDR s.58(b): The written procedure for recalls was not implemented by the company. (Consider risk associated with devices and recalls. If significant risk to health and safety or if recall not conducted, no records or if recalls conducted are ineffective, rate as Risk 1.)

Risk 3 (minor) observations

• MDR s.57(1)(b): Records of actions taken to deal with complaints were inadequate (missing minor elements but could still work).
• MDR s.58(a): The written procedure for handling complaints was inadequate (missing minor elements but could still work). (If procedures are completely missing or important elements missing, rate as Risk 2.)
• MDR s.58(b): The written procedure for recalling devices was inadequate (missing minor elements but could still work). (If procedures are completely missing or important elements missing, rate as Risk 2.)

Sections 59 to 61.6 Incident reporting, serious risk of injury to human health and summary reports

Risk 1 (critical) observations

• MDR s.59(1): The company did not submit an incident report for a reportable incident occurring in Canada. There was no mechanism in place and incidents were not being reported or there was a significant risk to health and safety.
• MDR s.59(1.1): The company did not submit an incident report for a reportable incident involving a Class I device outside Canada. There was no mechanism in place and incidents were not being reported, or there was a significant risk to health and safety.
• MDR s.60(1)(a)(i): The company did not submit a preliminary report within 10 days for an incident involving death or serious harm. Multiple reports were not submitted or high risk devices involved.
• MDR s.61.2(2): The company did not submit information in respect of any serious risk of injury to human health. There was no mechanism in place and information was not being reported or there was a significant risk to health and safety.

Risk 2 (major) observations

• MDR s.59(1): The company did not submit an incident report for a reportable incident occurring in Canada. (If incidents are not being reported and there is no mechanism in place at all or if significant risk to health and safety, rate as Risk 1.)
• MDR s.59(1.1): The company did not submit an incident report for a reportable incident involving a Class I device outside Canada. (If incidents are not being reported and there is no mechanism in place at all, or if significant risk to health and safety, rate as Risk 1.)
• MDR s.60(1)(a)(i): The company did not submit a preliminary report within 10 days for an incident in Canada involving death or serious harm. (Consider device's classification. If multiple reports were not submitted or if high risk devices, rate as Risk 1.)
• MDR s.60(1)(a)(ii): The company did not submit a preliminary report within 30 days for an incident in Canada that could have led to death or serious harm.
• MDR s.60(1)(b): The company did not submit a preliminary report for an incident that occurred outside Canada as soon as possible.
• MDR s.60(2)(a) to (i): The preliminary report did not contain the required information.
• MDR s.61.2(2): The company did not submit information in respect of any serious risk of injury to human health. (If information is not being reported and there is no mechanism in place at all, or if significant risk to health and safety, rate as Risk 1.)
• MDR s.61.2(3): The company did not submit information in respect of any serious risk of injury to human health within 72 hours.
• MDR s.61.4(1): The manufacturer did not prepare summary reports annually for Class III or IV devices or on a biennial basis for Class II devices.
• MDR s.61.4(2): The summary report did not cover all adverse effects, problems, incidents or serious risk of injury to human health.
• MDR s.61.4(3) to (5): The summary report did not contain the required sections.
• MDR s.61.4(6): Health Canada was not notified within 72 hours of a change in the benefits and risks associated with a device.
• MDS s.61.6(2): The manufacturer did not maintain records of summary reports and the information used to prepare the report for 7 years.

Risk 3 (minor) observations

• MDR s.59(1): The preliminary report was inadequate.
• MDR s.61(1): The final report was not submitted according to the timetable committed to by the company.
• MDR s.61(2)(a): The final report inadequately described the incident.
• MDR s.61(2)(b): The final report inadequately described the cause of incident and justification for actions taken. (Consider device's classification and risk associated with the device. If justification for actions taken do not address risk, rate as Risk 2.)
• MDR s.61(2)(c)(i) to (ii): The final report inadequately described the actions taken as a result of the investigation. (Consider device's classification and risk associated with the device. If actions taken as a result of the investigation do not address risk, rate as Risk 2.)
• MDR s.61.1(2): The manufacturer failed to notify Health Canada that the importer was preparing incident reports on its behalf.
• MDR s.61.3(2): The manufacturer failed to notify Health Canada that the importer was submitting the information in respect of any serious risk of injury to human health on its behalf.

Sections 63 to 65 Recall

Risk 1 (critical) observations

• MDR s.63.1: The company identified 1 or more reportable recalls as non-reportable. The number of unreported recalls led to significant risk to health and safety, or high risk recalls were not reported.
• MDR s.64: The company did not report 1 or more recalls. The number of unreported recalls led to significant risk to health and safety, or high risk recalls were not reported.

Risk 2 (major) observations

• MDR s.63.1: The company identified a reportable recall as non-reportable. (Consider the risk to health and the number of unreported recalls. If the number of unreported recalls leads to a significant risk to health and safety, or high risk recalls not reported, rate as Risk 1.)
• MDR s.63.2: The company did not provide a notification to Health Canada within 24 hours of making the decision to recall.
• MDR s.63.2(a) to (g): The company did not provide the required information to Health Canada within 24 hours of making the decision to recall.
• MDR s.64: The company did not provide an initial recall report to Health Canada.
• MDR s.64: The company did not report one or more recalls. (Consider the risk and the number of recalls. If the number of unreported recalls leads to significant risk to health and safety or high risk recalls not reported, rate as Risk 1.)
• MDR s.64: The company did not provide an initial recall report to Health Canada within the required timeline.
• MDR s.64(a) to (n): The initial recall report was inadequate.
• MDR s.65: The company did not submit a final recall report to Health Canada.
• MDR s.65: The company did not submit a final recall report to Health Canada within 30 days of completing the recall. (Consider the risk of the recall. If low risk, rate as Risk 3.)
• MDR s.65(a) to (b): The final recall report was inadequate. (Consider the risk of the recall. If low risk, rate as Risk 3.)
• MDR s.65.3: Recall records were missing for the manufacturer or the importer.
• MDR s.65.4(1) or (2): Recall records were missing for the distributor.
• MDR s.65.6(1) or (2): The company did not keep recall records for the required period of time.

Risk 3 (minor) observations

• MDR s.65: The company did not submit a final recall report within 30 days after completing the recall. (Consider the risk of the recall. If higher risk, rate as Risk 2.)
• MDR s.65(a) to (b): The final recall report was inadequate. (Consider the risk of the recall. If higher risk, rate as Risk 2.)
• MDR s.65.1(2): The manufacturer failed to notify Health Canada that the importer was preparing recall reports on its behalf. (Consider the risk of the recall. If higher risk, rate as Risk 2.)

Sections 66 to 68 Implant registration

Risk 2 (major) observations

• MDR s.66(1)(a) to (d): Implant registration cards did not include required information.
• MDR s.66(2)(a) to (e): Implant registration cards did not allow required information to be recorded.
• MDR s.66(3): Implant registration cards were not available in both English and French.
• MDR s.68(3): The company did not meet the requirements of sections 66 and 67 when implementing their alternate implant registration method.

Risk 3 (minor) observations

• MDR s.67(2): The patient's name and address were included on the implant registration card without the patient's written consent.
• MDR s.67(3): The company disclosed the patient's name and address when it was not required by law.

MDR, Part 2, Custom-made devices and medical devices to be imported or sold for special access

Section 70 General

Risk 1 (critical) observations

• MDR s.70: The company was consistently selling or importing Class III or IV devices without authorization. (Assess under section 26 of the MDR.)

Risk 2 (major) observations

• MDR s.70: The company sold or imported a Class III or IV device without authorization. (Assess under section 26 of the MDR.)

Section 75 Labelling

Risk 2 (major) observations

• MDR s.75(a) to (c): The company sold or imported a custom-made or special access device without proper labelling.

Section 76 Distribution records

Risk 1 (critical) observations

• MDR s.76: The company did not maintain distribution records and there was no process in place.

Risk 2 (major) observations

• MDR s.76: Distribution records were missing or inadequate. (The more records missing or inadequate, the higher the risk.)

Section 77 Reporting an incident

Risk 1 (critical) observations

• MDR s.77: Health care professional did not report incidents with custom-made or special access devices and there was no mechanism in place.

Risk 2 (major) observations

• MDR s.77: Health care professional did not report incidents within 72 hours.

MDR, Part 3, Medical devices for investigational testing involving human subjects

Section 80 General

Risk 1 (critical) observations

• MDR s.80(2): The company consistently sold Class II, III or IV devices to an investigator without authorization for investigational testing and without appropriate records.

Risk 2 (major) observations

• MDR s.80(2): The company sold a Class II, III or IV device to an investigator
• without authorization for investigational testing.
• MDR s.80(3): The company sold a Class I device to an investigator without maintaining appropriate records.

Section 81 Records

Risk 2 (major) observations

• MDR s.81(i): The company did not have records demonstrating the protocol for investigational testing and copies of patient consent forms.
• MDR s.81(k)(i): The company did not have written proof of the investigator's agreement to follow manufacturer protocol.
• MDR s.81(k)(ii): The company did not have written proof of the investigator's agreement to get patients' written consent.
• MDR s.81(k)(iii): The company did not have written proof of the investigator's agreement to use the device only for investigational testing.
• MDR s.81(k)(iv): The company did not have written proof of the investigator's agreement to forbid anyone from using the device unless under their direction.
• MDR s.81(k)(v): The company did not have written proof of the investigator's agreement to report incidents within 72 hours.

Risk 3 (minor) observations

• MDR s.81(a): Investigational testing records did not include the name, address and telephone number of the manufacturer and importer.
• MDR s.81(b): Investigational testing records did not include the name, classification and identifier of the device.
• MDR s.81(c): Investigational testing records did not include a description of the device and manufacturing and packaging materials.
• MDR s.81(d): Investigational testing records did not include a description of the device features, purposes and uses.
• MDR s.81(e): Investigational testing records did not include the foreign countries where the device was sold, total number of units sold, and any reported problems and recalls.
• MDR s.81(f)(i) to (iii): Investigational testing records did not include risk assessment and risk reduction measures.
• MDR s.81(g): Investigational testing records did not include the names of qualified investigators to whom the device is proposed to be sold.
• MDR s.81(h): Investigational testing records did not include the names and addresses of institutions that will be conducting investigational testing (and, for Class III or IV devices, written approval).
• MDR s.81(i): The company did not have adequate records demonstrating the protocol for investigational testing and copies of patient consent forms.
• MDR s.81(j): Investigational testing records did not include a copy of the device label.

Section 86 Labelling

Risk 2 (major) observations

• MDR s.86(a): The investigational testing device label did not include the name of the manufacturer.
• MDR s.86(b): The investigational testing device label did not include the name of the device.
• MDR s.86(d): The investigational testing device label did not include required statements about qualified investigator use only in French and English.
• MDR s.86(e): The in vitro diagnostic device label did not include cautions about performance specifications not being established, in both English and French.

Risk 3 (minor) observations

• MDR s.86(c): The investigational testing device label did not say "Investigational Device" in English and French.

Section 87 Advertising

Risk 2 (major) observations

• MDR s.87(a): The company advertised an investigational testing device without authorization.

Risk 3 (minor) observations

• MDR s.87(b): The company advertised an investigational testing device without indicating that the device is the subject of investigational testing, and for what purpose.

MDR, Part 4, Export certificates

Sections 89 to 92 Export certificates

Risk 1 (critical) observations

• MDR s.90: The company's export certificate was falsified or contained a forged signature. (False signature violates subsection 20(1) of the FDA.)

Risk 2 (major) observations

• MDR s.89(2)(a) to (b): The company's export certificate was not signed and dated.
• MDR s.90: The company's signed export certificate contained false or misleading information.
• MDR s.91: The company was unable to produce records of export certificates when requested by the inspector.
• MDR s.92: The company did not keep its export certificates for 5 years.

Risk 3 (minor) observations

• MDR s.89(1): The company's export certificate was inadequate.
• MDR s.89(2)(a) to (b): The company's export certificate was signed by the wrong person.
• MDR s.90: The company's signed export certificate was missing information.
• MDR s.91: The company's records of export certificates were inadequate or not maintained at the company's place of business.