Technical file review

Send us the documentation you have. We mark it against what the Regulation requires.

One defined piece of work. You receive a marked-up assessment of your existing file, a list of what is missing, and a cost for closing each gap. Machinery Regulation (EU) 2023/1230 applies from 20 January 2027.

Start a reviewThis is an inquiry. We reply with a scope confirmation before anything is agreed.
Engagement
Fixed scope
Fee
Quoted on enquiry
per equipment model, before any work begins
Turnaround
Agreed with the quotation
from receipt of a complete submission
Deliverable
Marked assessment, gap schedule, and remediation costing

What you send

A

Whatever the manufacturer gave you

Declaration of conformity, test reports, user manual, datasheets. Incomplete is expected — incomplete is the reason for the review.

B

The commercial documents

Purchase contract, invoice, shipping documents. These determine whether you are the importer, which determines everything else.

C

Photographs of the marking plate

CE mark, serial number, manufacturer identification as physically applied to the unit.

D

Any modification you have made

Software changes, attachments, integration with other equipment. Substantial modification can make you the manufacturer.

Nothing is uploaded at this stage. Documents are exchanged only once scope and terms have been agreed in writing.

What comes back

Part one

Position

Your role under the Regulation, stated plainly: importer, distributor, authorised representative or manufacturer. With the reasoning, so you can show it to your insurer or your lawyer.

Part two

Gap schedule

Every requirement the file does not currently meet, listed against the article that imposes it. Marked present, partial or absent.

Part three

Costed remediation

What closing each gap costs and who has to do it — you, the manufacturer, or a notified body. With the dates by which it has to happen.

Extract — gap schedule
Extract — gap schedule
Requirement
Status
Technical file available to a market surveillance authorityAbsent
Instructions supplied in GreekPartial
Risk assessment recordedPresent
Importer's name and address on the machineAbsent

Illustrative rows, showing the form a schedule takes rather than a finding. Requirement wording and the article behind each row are confirmed against the Official Journal on every review.

Who does the work

Dimitris Athanassiadis, FCCA

Twenty years of multi-entity group finance and international audit, in groups operating across 63 countries. Ergasa is in formation through October 2026. The file review is an inquiry with a quoted scope, not a closed-entity engagement.

Scope

What this is

A documentary assessment against the requirements of the Regulation, prepared by a qualified accountant with regulatory practice.

What this is not

Not a conformity assessment. Not a notified body opinion. Not legal advice, and not a substitute for it. Ergasa does not issue certificates and does not affix marks. Where a notified body is required, the review tells you so and what it will cost.

Start a review

4 fields
In service already?

No documents at this stage. We reply with a scope confirmation and a fee.

Related

The analysis this review is built on. Read the analysis

Relies on (EU) 2023/1230