Respirator or protective mask

Regimes engaged, per market

Standing when pasted with its name: reference

What the file has to hold

• Technical file (6 of the 7 regimes, including PPE Reg, REACH, UK PPE)
  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 (PPE Reg, UK PPE, 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 (PPE Reg, UK PPE, 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 (PPE Reg, UK PPE, OSHA PPE / NIOSH, 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 (5 of the 7 regimes, including PPE Reg, UK PPE, UKCA)
  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 (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 (PPE Reg, UK PPE, OSHA PPE / NIOSH, FDA devices)
  A type-examination certificate, notified or approved body certificate, or listing from a recognised laboratory, with the scope and the expiry.
• Substance declarations (REACH, UK REACH)
  Safety data sheets for mixtures and supplier material declarations for articles: the trail that shows what is in the product against the restricted lists.
• Post-market surveillance plan (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 (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 (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.
• Incident reporting (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.
• Recall readiness (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.
• Traceability records (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.
• Post-market surveillance and periodic reporting (FDA devices)
  Run the surveillance plan, analyse complaints, trends and field data, and produce the periodic safety update report the device rules require.
• Substance list watching (REACH, UK REACH)
  Track additions to the restricted and candidate substance lists, re-check supplier declarations against them, and update customer communication and labels when a substance in the product is added.

This week

Confirm whether the product claims to protect the wearer or the patient, because that puts it in PPE or in medical devices.