Pregnancy or ovulation self-test

Regimes engaged, per market

Standing when pasted with its name: mapped

What the file has to hold

• Technical file (5 of the 5 regimes, including IVDR, ISO 13485, UK MDR)
  The technical documentation: design, drawings, bill of materials, the standards applied, the conformity assessment route, and the evidence that the requirements are met. Kept for the retention period the regime sets, typically ten years from the last unit placed on the market.
• Declaration of conformity (IVDR, UK MDR, UKCA)
  The EU or UK declaration of conformity (or the food-contact declaration of compliance), signed by the manufacturer, naming the product, the legislation and the standards, and the notified or approved body where one was involved.
• Risk assessment (IVDR, ISO 13485, UK MDR, FDA IVD)
  The documented hazard identification and risk assessment for the product across its lifecycle, updated when the design, the use or the field data changes.
• Test reports (IVDR, UK MDR, FDA IVD)
  Test reports from an accredited or accepted laboratory against the standards the technical file names, tied to the exact model and revision tested.
• Labelling and instructions (IVDR, UK MDR, UKCA, FDA IVD)
  Markings on the product and packaging (conformity mark, identification, warnings, manufacturer and importer details) and the instructions and safety information in the language of the market.
• Traceability records (IVDR, ISO 13485, UK MDR, FDA IVD)
  Batch, lot or serial identification on the product, the records that tie a unit to its production and supply chain, and UDI where the device rules require it.
• Third-party certificate (IVDR, ISO 13485, UK MDR, FDA IVD)
  A type-examination certificate, notified or approved body certificate, or listing from a recognised laboratory, with the scope and the expiry.
• Post-market surveillance plan (IVDR, ISO 13485, UK MDR, FDA IVD)
  The plan and the periodic reports for collecting and acting on field experience, complaints and incidents, in the form the device rules set.
• Registrations (IVDR, UK MDR, FDA IVD)
  Producer, establishment, device or product registrations in the databases the regime names (EUDAMED, EPREL, CPNP, the WEEE and battery registers, FDA registration and listing).

Duties that continue after sale

• Market surveillance cooperation (IVDR, UK MDR, FDA IVD)
  Answer an authority's request for the technical file, the declaration and the supply chain within the time it sets, in a language it accepts, and cooperate with any corrective measure it requires.
  Licensed controls: IVDR Art.92, 93, 94, 95
• Incident reporting (IVDR, ISO 13485, UK MDR, FDA IVD)
  Notify the authority when a product has caused, or could cause, an accident, injury or serious incident, through the channel the regime names (the Safety Business Gateway, the MHRA, the FDA, SaferProducts.gov) and within its clock.
  Licensed controls: IVDR Art.82, 83, 84, 85, 86 · ISO 13485 8.2.3
• Recall readiness (IVDR, ISO 13485, UK MDR, FDA IVD)
  Be able to identify affected units, reach the customers who hold them, issue a notice in the required form, offer the remedy the rules require, and show the authority the effectiveness of the action.
  Licensed controls: IVDR Art.82, 83, 84, 85, 86 · ISO 13485 8.3.3 · ISO 13485 8.5.2
• Traceability records (IVDR, ISO 13485, UK MDR, FDA IVD)
  Keep the records that identify which batch went to which customer, and the identification on the product that lets a unit be traced back, for the retention period the regime sets.
  Licensed controls: IVDR Art.22, 23, 24, 25 · ISO 13485 7.5.8 · ISO 13485 7.5.9.1
• Post-market surveillance and periodic reporting (IVDR, ISO 13485, UK MDR, FDA IVD)
  Run the surveillance plan, analyse complaints, trends and field data, and produce the periodic safety update report the device rules require.
  Licensed controls: IVDR Art.78 · IVDR Art.80, 81 · ISO 13485 8.2.1 · ISO 13485 8.2.2 · ISO 13485 8.4

This week

Check the notified body certificate is under the IVDR and not a legacy Directive certificate, because the transition deadlines are running.

What holding one is evidence for

Requirement text and evidence artefacts from a human-verified corpus. Data licensed to Conformity Sheet by The Art of Service Pty Ltd, revocable, non-transferable.