Conformity assessment under the Machinery Directive
Changes due to Brexit
Your health and safety responsibilities will not change when the UK leaves the EU. This guidance is under review.
Under Article 12 of the Machinery Directive there are three routes for conformity assessment:
- the procedure for assessment of conformity with internal checks on the manufacture of machinery, provided for in Annex VIII
- the EC type-examination procedure provided for in Annex IX, plus the internal checks on the manufacture of machinery provided for in Annex VIII, point 3
- the full quality assurance procedure provided for in Annex X
Where the product is explicitly mentioned in Annex IV (part 4 of schedule 2 of the Supply of Machinery (Safety) Regulations 2008) the first option above (Annex VIII) is only available where the product is manufactured fully in accordance with transposed harmonised standards that cover all relevant essential health and safety requirements (EHSRs) for the product. Annex IV products include many types of woodworking machinery, chainsaws, presses for the working of cold metal, manually loaded and unloaded compression moulding machines for plastics and rubber, certain types of lifting equipment, as well as various safety components, including logic units ensuring safety functions.
Only the second and third options above are permitted for the conformity assessment of Annex IV products that are:
- not manufactured in conformity with transposed harmonised standards, or
- only partly in accordance with such standards, or
- if the harmonised standards do not cover all the relevant EHSRs, or
- if no harmonised standards exist for the product in question
Both of these options (2 & 3 above) require the involvement of a notified body.
Internal checks ('self certification') according to Annex VIII
In most cases manufacturers (or the manufacturer's authorised representative) do not need to use the services of a third party organisation (a notified body) while undertaking conformity assessment of their product. In these cases, at the end of the process, they make their own independent declaration on the Declaration of Conformity that the completed product satisfies the relevant provisions of the Directive. This is called "assessment of conformity with internal checks on the manufacture of machinery" (the Annex VIII route in the Directive), and is often referred to as the "self certification" route. A technical file must be drawn up in accordance with Annex VII for each representative type, and the manufacturer has to take all measures necessary in order that the manufacturing process ensures compliance with the technical file and the Directive. The technical file must be retained and made available on request to the market surveillance authorities for at least 10 years from the last date of manufacture.
EC Type-examination according to Annex IX
In this case (Annex IX procedure) the Responsible person submits the technical file, and makes available an example of the Annex IV product, to the notified body. The notified body follows the procedure set out in Annex IX, and if satisfied issues the Responsible Person with an EC type-examination certificate. This and the technical file must be retained by both parties for 15 years.
Before placing the product on the market the Responsible Person must declare conformity quoting the required details of the notified body on the Declaration of Conformity. Although the product has been assessed by an independent party, the responsible person remains fully responsible for the product's conformity with the Directive.
Annex IX describes other procedures in the event of the notified body not being satisfied that the product meets the EHSRs, review of EC type-examination certificates, and further requirements to enable market surveillance.
Full quality assurance according to Annex X
Again a notified body is involved, considering and auditing the quality system for the manufacturer of the product. This option will normally only be open to organisations with highly developed quality assurance systems. Full details are given in Annex X.
Before placing the product on the market the Responsible Person must declare conformity quoting the required details of the notified body on the Declaration of Conformity. Again, the responsible person remains fully responsible for the product's conformity with the Directive. The technical file must be retained and made available for at least 10 years from the last date of manufacture.