European Union · General Products

EU Machinery Regulation Compliance

A practical guide to EU Machinery Regulation Compliance for general products sold in the European Union: who it applies to, what to prepare, and the mistakes that cause rejection.

Who needs it

Machinery and partly completed machinery placed on the EU market; Manufacturers, importers, and authorised representatives

Authority

EU national market surveillance authorities

Legal basis

Regulation (EU) 2023/1230

Local representative

The EU importer or authorised representative is responsible

Timeline

Before placing on the market

Cost

Assessment and notified body costs vary by machine category

If you do not comply

Withdrawal, fines, and market bans

Who needs this

Machinery and partly completed machinery placed on the EU market
Manufacturers, importers, and authorised representatives

Documents you need

Technical file and risk assessment
EU declaration of conformity
Instructions in the required languages
Notified body certificate where applicable

Compliance checklist

Tick each item as you collect it. Saved in this browser only.

Technical file and risk assessment
EU declaration of conformity
Instructions in the required languages
Notified body certificate where applicable

How to comply

Confirm the product is machinery under the regulation
Carry out risk assessment and apply harmonised standards
Compile the technical file and declaration
Affix CE marking and provide instructions

Brief for your lab or agent

Copy this into an email, then edit the product and channel.

Request: EU Machinery Regulation Compliance — European Union
Product category: General Products
Authority: EU national market surveillance authorities
Legal basis: Regulation (EU) 2023/1230

Documents we already have:
  1. Technical file and risk assessment
  2. EU declaration of conformity
  3. Instructions in the required languages
  4. Notified body certificate where applicable

Questions:
  1. Does our product fall under EU Machinery Regulation Compliance in the European Union?
  2. Which test standards or evidence do you accept?
  3. What is the current fee and lead time?
  4. Is a local representative required, and can you act as one?

Cost and timeline

Before placing on the market.

Assessment and notified body costs vary by machine category.

Common rejection reasons

Risk assessment missing
Declaration does not match the machine
Instructions not in the required language

Registration, notification, or certification is not the same as approval. Keep the technical file current and make sure the label, listing, and submitted data match.