Laboratory or measuring equipment

Regimes engaged, per market

Standing when pasted with its name: mapped

What the file has to hold

• Technical file (11 of the 16 regimes, including GPSR, LVD, EMC)
  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 (7 of the 16 regimes, including LVD, EMC, RoHS)
  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 (5 of the 16 regimes, including GPSR, LVD, UK GPSR)
  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 (9 of the 16 regimes, including GPSR, LVD, EMC)
  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 (12 of the 16 regimes, including GPSR, LVD, EMC)
  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 (GPSR, UK GPSR)
  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 (OSHA/ANSI, UL/NRTL)
  A type-examination certificate, notified or approved body certificate, or listing from a recognised laboratory, with the scope and the expiry.
• FCC authorisation (FCC Part 15)
  The FCC Supplier's Declaration of Conformity, or the grant of certification with the FCC ID, and the compliance statement in the manual.
• Substance declarations (RoHS, REACH, UK RoHS, 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.
• Registrations (WEEE, UK WEEE)
  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 (GPSR, UK GPSR)
  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: GPSR Art.14, 15, 17 · GPSR Art.23, 24
• Incident reporting (GPSR, UK GPSR)
  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: GPSR Art.20 · GPSR Art.25, 26, 27
• Recall readiness (GPSR, UK GPSR)
  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: GPSR Art.35 · GPSR Art.36, 37
• Traceability records (GPSR, UK GPSR)
  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: GPSR Art.18 · GPSR Art.9
• Producer responsibility for take-back (WEEE, UK WEEE)
  Keep producer registrations current in each market, report the quantities placed, and finance collection and treatment of the product and its batteries at end of life.
• Substance list watching (RoHS, REACH, UK RoHS, 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

Check whether any instrument is sold for clinical diagnosis, because that moves it to the IVD regime.

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.