Your partner in clear product compliance

CE marking confirms that a product complies with all relevant EU directives. The process begins with determining which legislation applies, followed by standards selection, risk analysis, laboratory testing and compiling a technical file with EU declaration of conformity. Label, manual and packaging must also meet specific requirements before the CE logo can actually be used. Only when all these steps have been demonstrably completed may the CE logo be placed on the product, packaging and manual. Manufacturers keep the file for ten years and, depending on the assessment module, sometimes engage a notified body.

Instrux translates this process into clear actions. We list the legal requirements, explain the standards and create a clear action list. We then supervise the risk analysis, coordinate tests and draft the documentation so that every obligation from, for example, the Machinery Directive 2006/42/EC, the EMC Directive 2014/30/EU or the Low Voltage Directive 2014/35/EU is visibly covered. Our experts work with accredited laboratories and tightly monitor all deadlines.

With over 20 years of experience and a network of regulators across Europe, Instrux provides overview in a maze of regulations. Whether a quick review of existing files or a complete journey from idea to market entry, Instrux delivers a clear path that reduces risk and accelerates product launches.

The General Product Safety Regulation (EU) 2023/988 has been in force since December 13, 2024, and requires manufacturers, importers and distributors to place safe products on the market as well as ensure traceability with serial numbers or batch codes. In addition, warnings and instructions for use must be available in the language of the consumer, the contact address of the responsible party must be legibly displayed on the product or packaging, and full documentation must be provided within 10 days upon request.

Instrux helps with this pragmatically. We perform a risk analysis according to ISO 12100 or sector-specific standards, develop clear safety instructions and advise on simple but effective coding that can be followed throughout the chain. We then check labels, manuals and webshop texts for all mandatory data and record the results in a compact but complete safety file.

The end result is a specification that complies with the GPSR, allowing market entry.

The EU energy label lets consumers see at a glance how efficiently a product uses energy. Manufacturers and importers of refrigerators, dishwashers, monitors, lamps and heat pumps, among others, must register each model in the European Product Registry for Energy Labeling (EPREL) before sale.

Instrux takes this process completely out of your hands. We schedule laboratory tests, review reports, fill in the EPREL fields ensuring your registration meets the legal requirements. For new suppliers, we can provide support with verification, offering a discount on the eSeal in combination with one of our services.

In addition to registration, Instrux can also provide support with following the rest of the directive. After all, there are also requirements for packaging, manual and even website.
Everything must comply, otherwise penalties may follow.

A user manual is mandatory under virtually every EU directive. It must name residual risks, be written in understandable language and available in the language of the country of sale. Standard EN IEC 82079-1:2019 provides structure and quality requirements: fixed sequence covering safety, installation, use, maintenance and disposal, clear signal words and consistent pictograms.

Instrux develops or edits manuals that comply exactly with 82079-1. We inventory the target audience, determine the level of detail, and write short, active sentences that are immediately usable. Our specialists perform a readability check and link each safety requirement to the risk analysis, so that file and manual form one whole.

Those who already have documentation get an accurate compliance check with concrete revisions. If you don’t have anything yet, we provide a ready-made manuscript that can be set immediately or shared online. Instrux provides a library of standardized icons and signal words and, if desired, a template in Word. This approach prevents claims, reduces support questions and ensures that end users also find the right answer faster.

Manufacturers outside the European Economic Area need an Authorized Representative under Regulation (EU) 2019/1020 to place their products on the EU market. This Authorized Representative keeps the technical file for 10 years, answers market surveillance questions and coordinates corrective actions. The address of the representative must appear on product, packaging or accompanying document since July 16, 2021.

Instrux provides this service from the Netherlands. After a quick file check, we sign the mandate and our contact information can be printed directly on labels and manuals. Requested documents are delivered digitally, often within one business day.

Upon request, the representative must provide the EU Declaration of Conformity and complete technical file within ten days; Instrux monitors these deadlines with automatic notifications. With one fixed annual fee, you know exactly where you stand and can focus on product development and sales.