Manufacturers may need an Authorised Representative in the EU from July 2021

Derek Coulson is a Director of Hold Tech Files Ltd, based in the Republic of Ireland. He has worked in the field of machinery Safety since 1995 and is currently a Technical Advisor with Safe Machine Ltd 

If you supply CE marked goods or products, (including machinery), into the EU, there is a new Regulation 2019/2020 on market surveillance and compliance of products that comes into force on 16th July 2021. It strengthens the requirements for market surveillance by Member States.

The new Regulation prohibits the placing on the market of certain goods unless there is what is called an ‘economic operator’ established in the EU, with responsibility for ensuring that the necessary conformity documentation is available, co-operating with market surveillance authorities and informing authorities if there are reasons to believe that a product presents a risk.

These ‘economic operators’ are defined as: -

the manufacturer of the goods,

the importer (where the manufacturer is not established in the EU),

a fulfilment service provider when none of the above are established in the EU, or

an authorised representative.

They are defined as: -

‘manufacturer’ means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under its name or trademark; 

‘importer’ means any natural or legal person established within the Union who places a product from a third country on the Union market; 

‘fulfilment service provider’ means any natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved, excluding postal services as defined in point 1 of Article 2 of Directive 97/67/EC of the European Parliament and of the Council ( 31), parcel delivery services as defined in point 2 of Article 2 of Regulation (EU) 2018/644 of the European Parliament and of the Council ( 32), and any other postal services or freight transport services;

‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks with regard to the manufacturer's obligations under the relevant Union harmonisation legislation or under the requirements of this Regulation;

For machinery manufacturers based outside the EU, there must currently be a person to ‘compile’ the Technical File, identified on the Declaration of Conformity: effectively someone to provide the Technical File within the EU. This person has no responsibility other than providing a Technical File on reasoned request from authorities, who could be Trading Standards, Health and Safety Authorities etc. 

From July 2020, the new Regulation requires an Authorised Representative, with a mandate to co-operate with the authorities, if there is no other economic operator. 

The requirements apply to products affected by Directives listed in Annex I of 2019/1020. 

A Union Product Compliance Network is being established from January 1st 2021: the purpose of the Network is to ‘serve as a platform for structured coordination and cooperation between enforcement authorities of the Member States and the Commission, and to streamline the practices of market surveillance within the Union, thereby making market surveillance more effective’. readers might want to note that Hold Tech Files Ltd can act as the ‘person’ to compile Technical Files for the Machinery Directive, and that the company can also can act as the Authorised Representative for any of the Directives listed in Annex I.

The company can be contacted online at or by email using

Hold Tech Files can assist with compliance when the new regulations come into force
Hold Tech Files can assist with compliance when the new regulations come into force

Hold Tech Files Ltd

Dun Iseal House, Newtown, Gaulsmills

More news
1 day ago
NSK bearings reduce concrete floor manufacturing machine failures to zero
Regular bearing failures in a concrete floor manufacturing machine were leading to extensive downtime, costly lost production, and high maintenance costs. To rectify the problem, the customer turned to the expertise of NSK for a redesigned wheel hub and stub axle assembly.
3 days ago
Servodrives help protect chair castors and cut packaging costs
Drives and motors specialist Yaskawa has played a key role in the development of an automated system specifically designed to fit protective plastic caps onto chair castors, using its Sigma-7 series servo-drives and a SLIO-series controller.
6 days ago
SKF streamlines bearing analysis for Ansys users
With the new SKF Bearing App for Ansys Mechanical, design engineers have instant access to accurate stiffness data on more than 10,000 bearing designations. The app is available in the Ansys Store free of charge.
6 days ago
Omron awarded platinum rating from EcoVadis for sustainability
Omron has been awarded the Platinum rating following a sustainability assessment by EcoVadis. A score earning a Platinum rating, which is the highest distinction, puts the company within the top 1% of all the businesses assessed for sustainability performance.
1 week ago
ABB Value Provider wins order for rolling mill DC drive solution
DC drive specialist Iconsys is set to deliver a bespoke drive upgrade solution comprising two 12-pulse drive suites from ABB for a UK steel mill’s payoff and tension reels, used to feed and recoil steel strip through a production line.
1 week ago
What are the design considerations when specifying lead screws?
The first in the new ‘Design • Engineer • Build’ series of video podcasts focuses on lead screws – components that are at the heart of countless engineering systems. We talk to Phil Jones at Abssac about the enduring popularity of these essential design products, and the design considerations in their specification.
1 week ago
Harting honoured with the ‘Best of Industry Award’
The industry media of the Vogel Communications Group presented their ‘Best of Industry Awards’ shortly before the turn of the year. The Harting Technology Group emerged as the winner in the ‘Electrical Equipment’ category with its Han-Modular Domino modules.
1 week ago
Quick ROI and 60% decrease in maintenance travel with remote access
Brazilian surface treatment systems manufacturer Erzinger was keen to limit service trips as much as possible to serve customers faster. By implementing IXON Cloud, it can now support its customers remotely, and work in an intuitive and secure way. It can even set up multiple simultaneous connections to work together on the same project. The result is cost reduction, quick ROI and happier customers.
2 weeks ago
Nord high up in the sustainability ranking
Nord Drivesystems was assessed by the rating agency EcoVadis and awarded the silver sustainability certificate in 2022. In the overall ranking, the North German company is in the top six percent of manufacturers in the industry assessed by EcoVadis.
2 weeks ago
Mitsubishi Electric helps door manufacturer triple its throughput
Renowned door manufacturer Profile Developments has seen a threefold increase in its productivity, thanks to its latest collaboration with Mitsubishi Electric, with a solution based on multiple FR-E series inverter or variable speed drives (VSDs) and other system-matched components, such as a GOT 2000 series HMI and MELSEC iQ-R PLC.

Login / Sign up