Tekfile · Machinery technical files for the EU and Saudi Arabia

No
postponement

Status as of 26 October 2026

86days to 20 January 2027

“It shall apply from 20 January 2027.”
Article 54, English text of the Official Journal. [Reg. 2023/1230 Art. 54]

The Regulation repeals Directive 2006/42/EC on 20 January 2027 and sets no overlap period: every single unit placed on the market from that day must be declared under the new text. Machines placed before then may stay on the market, and EC type-examination certificates stay valid until they expire. [Reg. 2023/1230 Art. 51(2)] [Reg. 2023/1230 Art. 52(1)] [Reg. 2023/1230 Art. 52(2)] [Blue Guide 2022 §2.3]

At the expert group (MEG) meeting of 27 April 2026 the Commission recorded that no delay of the cybersecurity requirements is foreseen. UCIMU asked for twelve more months under strict conditions. No act has moved the date so far. MEG 27 Apr 2026, p. 9 UCIMU, 31 Jul 2026

What changes for you

Requirement	In practice	Source
Digital instructions	Allowed on three conditions: the machine shows how to reach them; they can be printed, downloaded and saved, also during a breakdown; they stay online for the machine's expected lifetime and for at least 10 years. A paper copy requested at purchase is free within one month.	`[Reg. 2023/1230 Art. 10(7)(a)]` `[Reg. 2023/1230 Art. 10(7)(b)]` `[Reg. 2023/1230 Art. 10(7)(c)]` `[Reg. 2023/1230 Art. 10(7)]`
Digital EU declaration	Instead of an enclosed copy, the instructions may give the internet address or machine-readable code of the declaration, which stays online for the machine's expected lifetime and at least 10 years. The new model asks for the date of every specification applied. A Commission proposal, not yet adopted, would make the declaration and instructions digital.	`[Reg. 2023/1230 Art. 10(8)]` `[Reg. 2023/1230 Annex V Part A (7)]` `[COM(2025) 504]`
Technical file	Annex IV lists fifteen items, (a) to (o). New ones: source code or programming logic of safety software on reasoned request, a description of data and validation for sensor-fed or autonomous machines, and the EU declarations of incorporated products under other harmonisation legislation.	`[Reg. 2023/1230 Annex IV Part A]` `[Reg. 2023/1230 Annex IV Part A (k)]` `[Reg. 2023/1230 Annex IV Part A (m)]` `[Reg. 2023/1230 Annex IV Part A (n)]`
Annex I, Part B	Among others, circular and band saws for wood or meat of the listed types, manually loaded presses and press brakes for metal (travel over 6 mm, speed over 30 mm/s), manually loaded plastics or rubber injection moulding machines, person-detecting devices and safety logic units. Internal control is allowed only with harmonised standards or common specifications covering all requirements. As of October 2026 no standard is cited under the Regulation, and until standards or common specifications exist a notified body is needed.	`[Reg. 2023/1230 Annex I Part B]` `[Reg. 2023/1230 Art. 25(3)]` `IBF, OJ list`
Connections, software and data	A connection, including a remote one, must not create a hazardous situation; software and data critical for compliance are protected against corruption and the machine collects evidence of interventions. Control systems withstand reasonably foreseeable malicious attempts. The tracing log of interventions and safety software versions stays enabled for five years, used only on a reasoned request from an authority.	`[Reg. 2023/1230 Annex III §1.1.9]` `[Reg. 2023/1230 Annex III §1.2.1(a)]` `[Reg. 2023/1230 Annex III §1.2.1(f)]`
Substantial modification	Whoever modifies a machine already in service, including by software alone, in a way the manufacturer did not foresee, creating a new hazard or increasing a risk that calls for new guards with a change to the safety control system, or for new stability or strength measures, becomes its manufacturer with the manufacturer's obligations. Revamps and upgrades on installed lines can fall here.	`[Reg. 2023/1230 Art. 18]` `[Reg. 2023/1230 Art. 3(16)]`
Marking and contact	The machine carries its model, year of construction and serial number, with the manufacturer's name, postal address and a digital contact.	`[Reg. 2023/1230 Art. 10(5)]` `[Reg. 2023/1230 Art. 10(6)]`

Digital instructions

[Reg. 2023/1230 Art. 10(7)(a)] [Reg. 2023/1230 Art. 10(7)(b)] [Reg. 2023/1230 Art. 10(7)(c)] [Reg. 2023/1230 Art. 10(7)]

Allowed on three conditions: the machine shows how to reach them; they can be printed, downloaded and saved, also during a breakdown; they stay online for the machine's expected lifetime and for at least 10 years. A paper copy requested at purchase is free within one month.

Digital EU declaration

[Reg. 2023/1230 Art. 10(8)] [Reg. 2023/1230 Annex V Part A (7)] [COM(2025) 504]

Instead of an enclosed copy, the instructions may give the internet address or machine-readable code of the declaration, which stays online for the machine's expected lifetime and at least 10 years. The new model asks for the date of every specification applied. A Commission proposal, not yet adopted, would make the declaration and instructions digital.

Technical file

[Reg. 2023/1230 Annex IV Part A] [Reg. 2023/1230 Annex IV Part A (k)] [Reg. 2023/1230 Annex IV Part A (m)] [Reg. 2023/1230 Annex IV Part A (n)]

Annex IV lists fifteen items, (a) to (o). New ones: source code or programming logic of safety software on reasoned request, a description of data and validation for sensor-fed or autonomous machines, and the EU declarations of incorporated products under other harmonisation legislation.

Annex I, Part B

[Reg. 2023/1230 Annex I Part B] [Reg. 2023/1230 Art. 25(3)] IBF, OJ list

Among others, circular and band saws for wood or meat of the listed types, manually loaded presses and press brakes for metal (travel over 6 mm, speed over 30 mm/s), manually loaded plastics or rubber injection moulding machines, person-detecting devices and safety logic units. Internal control is allowed only with harmonised standards or common specifications covering all requirements. As of October 2026 no standard is cited under the Regulation, and until standards or common specifications exist a notified body is needed.

Connections, software and data

[Reg. 2023/1230 Annex III §1.1.9] [Reg. 2023/1230 Annex III §1.2.1(a)] [Reg. 2023/1230 Annex III §1.2.1(f)]

A connection, including a remote one, must not create a hazardous situation; software and data critical for compliance are protected against corruption and the machine collects evidence of interventions. Control systems withstand reasonably foreseeable malicious attempts. The tracing log of interventions and safety software versions stays enabled for five years, used only on a reasoned request from an authority.

Substantial modification

[Reg. 2023/1230 Art. 18] [Reg. 2023/1230 Art. 3(16)]

Whoever modifies a machine already in service, including by software alone, in a way the manufacturer did not foresee, creating a new hazard or increasing a risk that calls for new guards with a change to the safety control system, or for new stability or strength measures, becomes its manufacturer with the manufacturer's obligations. Revamps and upgrades on installed lines can fall here.

Marking and contact

[Reg. 2023/1230 Art. 10(5)] [Reg. 2023/1230 Art. 10(6)]

The machine carries its model, year of construction and serial number, with the manufacturer's name, postal address and a digital contact.

Which duties apply to you

Pick a market and a machine family and the table shows the Gap Audit rows that probably concern you, each with its source.

Gap Audit · preview21 rows apply

Market	Requirement	Source
EU	Technical file with items (a)–(o) of Annex IV	`[Reg. 2023/1230 Annex IV Part A]`
EU	Risk assessment listing the applicable requirements and the measure for each	`[Reg. 2023/1230 Annex IV Part A (b)]`
EU	EU declaration of conformity on the new model	`[Reg. 2023/1230 Art. 21]` `[Reg. 2023/1230 Annex V Part A]`
EU	Marking: model, year, serial, name, address and digital contact	`[Reg. 2023/1230 Art. 10(5)]` `[Reg. 2023/1230 Art. 10(6)]`
EU	Family not listed in Annex I: internal production control	`[Reg. 2023/1230 Art. 25(4)]`
EU	Manually loaded circular or band saws for meat: Annex I, Part B	`[Reg. 2023/1230 Annex I Part B (1)]` `[Reg. 2023/1230 Annex I Part B (4)]`
EU	Annex I, Part B: without cited harmonised standards a notified body is needed	`[Reg. 2023/1230 Annex I Part B]` `[Reg. 2023/1230 Art. 25(3)]`
EU	Digital instructions with access marked, printable and downloadable, online for the expected lifetime and at least 10 years	`[Reg. 2023/1230 Art. 10(7)(a)]` `[Reg. 2023/1230 Art. 10(7)(b)]` `[Reg. 2023/1230 Art. 10(7)(c)]`
EU	Free paper copy within one month, if requested at purchase	`[Reg. 2023/1230 Art. 10(7)]`
EU	EU declaration online for the expected lifetime and at least 10 years, address or code in the instructions	`[Reg. 2023/1230 Art. 10(8)]`
EU	Protection of connections, safety software and data against corruption	`[Reg. 2023/1230 Annex III §1.1.9]`
EU	Controls that withstand malicious attempts; version log kept five years	`[Reg. 2023/1230 Annex III §1.2.1(a)]` `[Reg. 2023/1230 Annex III §1.2.1(f)]`
EU	Substantial modification: whoever carries it out becomes the manufacturer	`[Reg. 2023/1230 Art. 18]`
KSA	Type 1a certificate from a SASO-accepted body	`[SASO TR 01-02-04-23-196 Art. 6/1]`
KSA	Supplier's declaration (Annex 5) and risk assessment document	`[SASO TR 01-02-04-23-196 Art. 6/3]`
KSA	Plate: manufacturer and address, designation, type, serial, year	`[SASO TR 01-02-04-23-196 Annex 2 §1.7.3]`
KSA	Warnings in Arabic or in a language easily understood	`[SASO TR 01-02-04-23-196 Annex 2 §1.7.1]`
KSA	Instructions in Arabic or in a formally agreed language	`[SASO TR 01-02-04-23-196 Annex 2 §1.7.4.1]`
KSA	Saws: check on SABER whether the HS code falls under Part 4, where Arabic is mandatory	`[SASO TR 01-02-05-23-188 Art. 5/3]` `[SASO SABER §HS codes]`
KSA	Presses: the applicable regulation must be checked on the 12-digit HS code	`[SASO SABER §HS codes]`
KSA	SABER registration by the importer, a certificate per shipment	`[SASO SABER §Product certificate]` `[SASO SABER §Shipment certificate]`

Indicative preview: the final picture depends on the 12-digit HS code and on the risk assessment of your machine.

And for Saudi Arabia

Most of the file carries over; you add the SASO supplier declaration, the Arabic texts and a Type 1a certificate. Industrial machines mostly fall under the SASO technical regulation on general machinery safety requirements, in force since 2024. [SASO SABER §HS codes]

TR 2024

The general regulation

[SASO TR 01-02-04-23-196 Art. 2/1]

Technical Regulation for General Requirements for Machinery Safety, SASO decision 132, Gazette of 29 March 2024. Its scope lists the same product categories as the Machinery Directive.

Type 1a

Before customs

[SASO TR 01-02-04-23-196 Art. 6/1] [SASO TR 01-02-04-23-196 Annex 3]

Before customs you need a type-examination certificate (ISO/IEC 17067) from a SASO-accepted body, chosen on SABER.

Manufacturer

Who applies

[SASO TR 01-02-04-23-196 Annex 3 §2/1/1]

The manufacturer applies to the body, with the technical documentation and an adequate analysis and assessment of the risks.

File

What it holds

[SASO TR 01-02-04-23-196 Art. 6/3] [SASO TR 01-02-04-23-196 Annex 5]

The file holds the supplier's declaration on the Annex 5 model and the risk assessment document.

Arabic

Language of instructions and warnings

[SASO TR 01-02-04-23-196 Annex 2 §1.7.4.1] [SASO TR 01-02-04-23-196 Annex 2 §1.7.1]

Instructions in Arabic, or in a language formally agreed with the user or final importer. Warnings in Arabic or in a language easily understood.

Part 4

Sawing and cutting machines

[SASO TR 01-02-05-23-188 Art. 5/3]

For sawing and cutting machines Arabic is mandatory; other languages are allowed only in addition.

SABER

Registration and fees

[SASO SABER §Product registration] [SASO SABER §Product certificate] [SASO SABER §Shipment certificate]

The importer registers on SABER. The product certificate costs SAR 500 a year, the shipment certificate SAR 350 for 90 days.

12-digit HS

The code decides the regulation

[SASO SABER §HS codes] [GSO BD-142004-01]

The applicable regulation depends on the 12-digit HS code. In the SABER tool, packaging machines and most food machines go to the general TR, several woodworking lines to Part 4, pumps to the GCC low-voltage regulation.

Prices	Gap Audit€1,500 list price €2,500	EU + Saudi technical file€5,000–9,000 list price €8,000–15,000, by complexity	Digital instructions and 3D parts portal€3,500–7,000 setup, list price €6,000–12,000
Scope	One machine family	One machine	Per manufacturer: models and serials
What you get	Your file checked against Annex IV and the SASO and SABER requirements; scored gap table; action plan; the list of Arabic labels and warnings you need.	Risk assessment by the ISO 12100 method, valid for Annex IV and for the SASO regulation; restructured instructions; Arabic safety section and labels; drafts of the EU declaration and of the SASO supplier declaration for the manufacturer to sign; SABER-ready data.	Instructions and EU declaration online per model and serial, with every version; QR per serial; print and download. In a second phase, an exploded 3D parts catalogue from your CAD, with parts requests.
Time	5 working days	3–5 weeks	3–4 weeks for the first model
Hosting	None	None	€150–400 a month (list price €200–600), or 10 years prepaid on one invoice
Terms	50% on order, balance on delivery. Full refund if the audit finds no gap whose correction would cost more than the audit itself.	Handed over to your notified body or to the SASO-accepted body you choose.	Your own domain and a complete static export on termination, both in the contract.
Launch prices for the first three clients, with the list price beside them. `[Reg. 2023/1230 Art. 10(7)(c)]` `[Reg. 2023/1230 Art. 10(8)]`	Ask for the Gap Audit	Ask for a quote	Ask for a quote

Launch prices for the first three clients, with the list price beside them.

Gap Audit

€1,500 list price €2,500

Time: 5 working days

What it includes and terms

Scope: One machine family
What you get: Your file checked against Annex IV and the SASO and SABER requirements; scored gap table; action plan; the list of Arabic labels and warnings you need.
Hosting: None
Terms: 50% on order, balance on delivery. Full refund if the audit finds no gap whose correction would cost more than the audit itself.

Ask for the Gap Audit

EU + Saudi technical file

€5,000–9,000 list price €8,000–15,000, by complexity

Time: 3–5 weeks

What it includes and terms

Scope: One machine
What you get: Risk assessment by the ISO 12100 method, valid for Annex IV and for the SASO regulation; restructured instructions; Arabic safety section and labels; drafts of the EU declaration and of the SASO supplier declaration for the manufacturer to sign; SABER-ready data.
Hosting: None
Terms: Handed over to your notified body or to the SASO-accepted body you choose.

Ask for a quote

Digital instructions and 3D parts portal

€3,500–7,000 setup, list price €6,000–12,000

Time: 3–4 weeks for the first model

What it includes and terms

Scope: Per manufacturer: models and serials
What you get: Instructions and EU declaration online per model and serial, with every version; QR per serial; print and download. In a second phase, an exploded 3D parts catalogue from your CAD, with parts requests.
Hosting: €150–400 a month (list price €200–600), or 10 years prepaid on one invoice
Terms: Your own domain and a complete static export on termination, both in the contract.

Ask for a quote

[Reg. 2023/1230 Art. 10(7)(c)] [Reg. 2023/1230 Art. 10(8)]

Ongoing support (variants, new serials, data for SABER renewals): €500–1,500 a month.

Review of the file by an external CE consultant: at cost, invoiced separately.

Times run from receipt of the complete documentation, excluding the body's and the reviewer's time. Prices before any applicable taxes, invoicing terms in the quote. The 20-minute check with its one-page checklist is free.

Sample Gap Audit, 3 rows

Sample Gap Audit · Linea demo LD-200fictitious machine, 3 rows of 125

ID	Requirement	Reference	Status	Weight
EU-IV-b	Risk assessment with the applicable requirements and residual risks	`[Reg. 2023/1230 Annex IV Part A (b)]`	partial	3
EU-10-7a	Access to the digital instructions marked on the machine	`[Reg. 2023/1230 Art. 10(7)(a)]`	missing	3
KSA-6-1	Type 1a certificate from a SASO-accepted body	`[SASO TR 01-02-04-23-196 Art. 6/1]`	missing	3

Prepared for review by the manufacturer and its notified body.

We are not a notified body

Tekfile does not certify and issues no certificates. We prepare the file; the manufacturer signs the EU declaration and so takes responsibility for conformity; where required, the notified body examines and certifies. Every document is prepared for review by the manufacturer and its notified body. [Reg. 2023/1230 Art. 21(4)] [Reg. 2023/1230 Art. 25(3)]

Sample EU declaration, excerpt

EU declaration of conformityAnnex V, Part A · excerpt, fictitious machine

1. Machinery (product, type, model, serial number): Linea demo LD-200/A, serial SN-2027-0001
2. Manufacturer: Esempio Macchine S.r.l., Via dell’Esempio 1, 20100 Milano
4. Declaration issued under the sole responsibility of the manufacturer
6. Union harmonisation legislation: Regulation (EU) 2023/1230
7. Harmonised standards or other technical specifications applied, with their date: EN ISO 12100:2010, applied as another technical specification

Points summarised from [Reg. 2023/1230 Annex V Part A]

Who is behind it

Master's in mechanical engineering, Politecnico di Milano — Digital Technologies for Product Development (3D, VR/AR), completing; working languages Italian, French, Arabic, English.

IT FR
AR ENThe languages we work in

Training: Politecnico di Milano
Signs the declaration: The manufacturer

Contact

Write with the machine's name and its target market. We answer in Italian, English, French or Arabic.

E-mailmael@tekfile.com WhatsApp+39 351 317 1685 20 minutes, freeFree check

Nopostponement

What changes for you

Which duties apply to you

And for Saudi Arabia

TR 2024

Type 1a

Manufacturer

File

Arabic

Part 4

SABER

12-digit HS

Prices

Gap Audit

EU + Saudi technical file

Digital instructions and 3D parts portal

We are not a notified body

Who is behind it

Contact

No
postponement