Wound dressing or plaster

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 MDR, 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 (MDR, 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 (MDR, ISO 13485, UK MDR, FDA devices)
  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 (MDR, UK MDR, FDA devices)
  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 (MDR, UK MDR, UKCA, FDA devices)
  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 (MDR, ISO 13485, UK MDR, FDA devices)
  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 (MDR, ISO 13485, UK MDR, FDA devices)
  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 (MDR, ISO 13485, UK MDR, FDA devices)
  The plan and the periodic reports for collecting and acting on field experience, complaints and incidents, in the form the device rules set.
• Registrations (MDR, UK MDR, FDA devices)
  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 (MDR, UK MDR, FDA devices)
  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.
  Controls with requirement text: MDR Art.93, 94, 95, 96, 97, 98
• Incident reporting (MDR, ISO 13485, UK MDR, FDA devices)
  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.
  Controls with requirement text: MDR Art.87, 88, 89, 90, 91, 92 · ISO 13485 8.2.3
• Recall readiness (MDR, ISO 13485, UK MDR, FDA devices)
  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.
  Controls with requirement text: MDR Art.87, 88, 89, 90, 91, 92 · MDR Art.10 · ISO 13485 8.3.3 · ISO 13485 8.5.2
• Traceability records (MDR, ISO 13485, UK MDR, FDA devices)
  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.
  Controls with requirement text: MDR Art.25, 27, 28 · ISO 13485 7.5.8 · ISO 13485 7.5.9.1
• Post-market surveillance and periodic reporting (MDR, ISO 13485, UK MDR, FDA devices)
  Run the surveillance plan, analyse complaints, trends and field data, and produce the periodic safety update report the device rules require.
  Controls with requirement text: MDR Art.83 · MDR Art.84, 85, 86 · ISO 13485 8.2.1 · ISO 13485 8.2.2 · ISO 13485 8.4

This week

Separate sterile from non-sterile products on the sheet; the sterile ones carry a notified body and a validated sterilisation process.

What holding one is evidence for

Requirement text and evidence artefacts in our words, read from the published standards and cited. The Art of Service publishes both Conformity Sheet and that reading of the standards: each requirement is our statement of its clause, not the instrument verbatim, read from the published text and cited to it so you can check it against the official text.