| Testing by the maker (Great Britain) | The Supply of Machinery (Safety) Regulations 2008 require the responsible person to carry out, or have carried out, the research and tests on components, fittings or the completed machinery needed to decide whether it can be assembled and put into service safely (regulation 7(3); regulation 8(4) for partly completed machinery). | The FAT is your check on the equipment, not the vendor’s conformity assessment. Ask to see the vendor’s own tests and risk assessment before the visit. |
| Declaration and marking (Great Britain) | Before machinery is placed on the market or put into service: the essential health and safety requirements met, a technical file, instructions, a conformity assessment procedure, a declaration of conformity that accompanies the machinery and the UK marking (regulation 7(2)). Regulation 12A accepts the EC declaration and CE marking under the Machinery Directive instead. | Check which declaration and marking the contract asks for, and that they will ship with the equipment. |
| Partly completed machinery (Great Britain) | Comes with technical documentation, assembly instructions and a declaration of incorporation, which stay with it until it is built into machinery and then form part of that machinery’s technical file (regulation 8). | A module or skid built into a larger line may ship with a declaration of incorporation, not a declaration of conformity. Agree which one you will receive. |
| EU Machinery Regulation | Regulation (EU) 2023/1230 on machinery repeals the Machinery Directive 2006/42/EC. The European Commission says it applies on a mandatory basis from 20 January 2027, and machinery placed on the market before that date must comply with the Directive. | For equipment shipping around January 2027, agree which law the declaration will cite. |
| Great Britain from 20 January 2027 | An amendment (S.I. 2026/867, in force 20 January 2027) treats machinery that meets the EU Machinery Regulation, with its EU declaration of conformity and CE marking, as meeting the requirements of regulation 7(2). | A CE-marked machine under the new EU Regulation will still be accepted in Great Britain on that route. |
| Machine guarding (US) | 29 CFR 1910.212 requires one or more methods of guarding to protect the operator and others in the machine area from hazards such as the point of operation, ingoing nip points, rotating parts, flying chips and sparks, and machines designed for a fixed location to be securely anchored. | The duty falls on the employer using the machine. Check the guards at the FAT, while the vendor can still change them. |
| GMP equipment (US) | 21 CFR 211.63: equipment of appropriate design, adequate size and suitably located for its intended use and for cleaning and maintenance. 21 CFR 211.68: automatic and computerised equipment calibrated, inspected or checked under a written programme, with controls so that only authorised personnel change records, and backups kept. | Test product-contact parts, cleanability and computerised system controls at the FAT, and agree which results your qualification will rely on. |
| Process automation systems | IEC 62381:2024 (edition 3) defines requirements and checklists for the FAT, factory integration test, SAT and site integration test of automation systems in the process industry, so the owner, buyer and vendor can agree the scope of activities and responsibilities. | A useful basis for the protocol of a control or automation system. It is a paid standard; buy it from the IEC if you work to it. |