Overview
Selling into the European Union now needs two things the manufacturer must hold before the first unit ships: a CE technical file under the directives that apply to the product, and from 13 December 2024 a GPSR document pack under the General Product Safety Regulation (EU) 2023/988. Marketplaces such as Amazon ask for both and suspend listings when they are missing or inconsistent.
Both are built from the same evidence: a product description, a risk assessment, test reports to harmonised standards, user instructions and labelling, and a signed EU Declaration of Conformity. The file is only as good as its weakest document. A test report that names a different model, or a declaration missing the standard editions, fails the whole pack.
Aaditech prepares the file from scratch or reviews the documents you already hold. Our engineers read the reports rather than ticking a checklist, which is what distinguishes this service from document-upload platforms.
Who needs it
- Indian manufacturers and exporters shipping electrical, electronic, lighting, battery-powered and other consumer products to the EU or UK.
- Amazon, eBay, Etsy and Shopify sellers whose EU listings require GPSR and CE documents.
- Suppliers to EU importers who are asked for a technical file and a Declaration of Conformity as a condition of the purchase order.
- Brands entering Europe who need to appoint an EU Authorised Representative and must present a reviewed document pack to do so.
Products covered
GPSR applies to all consumer products not covered by product-specific EU law. The CE directives most relevant to Indian exporters are:
| Directive or Regulation | Products |
|---|---|
| Low Voltage Directive 2014/35/EU | Mains electrical equipment 50 to 1,000 V AC |
| EMC Directive 2014/30/EU | Anything with electronics |
| Radio Equipment Directive 2014/53/EU | Wi-Fi, Bluetooth, cellular and other radio products |
| RoHS Directive 2011/65/EU | Electrical and electronic equipment |
| Toy Safety Directive 2009/48/EC | Toys for children under 14 |
| Machinery Directive 2006/42/EC, Machinery Regulation 2023/1230 from 20 January 2027 | Machines and partly completed machinery |
| PPE Regulation 2016/425 | Protective equipment |
| Battery Regulation 2023/1542 | Batteries and products containing them |
We also handle UKCA and UK Responsible Person documentation for Great Britain, where CE marking continues to be recognised for most goods.
Documents required
For the CE technical file:
- Product description, photographs, drawings and bill of materials
- List of applicable directives and harmonised standards, with editions
- Risk assessment covering hazards, foreseeable misuse, controls and residual risk
- Test reports to the harmonised standards, from an ISO/IEC 17025 accredited laboratory
- RoHS and REACH evidence
- User instructions and safety information in the languages of the markets served
- Label artwork with CE mark, manufacturer name and address, model and batch
- EU Declaration of Conformity signed by the manufacturer
Additionally for GPSR:
- Internal risk analysis in the GPSR format
- Manufacturer name, registered address and electronic address on the product or packaging
- Name and address of the EU responsible economic operator on the product, packaging or accompanying document
- Record of the responsible economic operator appointment
Process
- Scope. We identify the directives, standards and GPSR obligations for each product family and sales channel.
- Document audit. You share what you hold. We check every report and certificate for lab accreditation, standard edition, model and rating coverage, validity and consistency across documents.
- Gap list. A written list of what is missing, what needs correction and what testing is required, with options for ILAC-accredited labs in India or Europe.
- Build. We write the risk assessment, assemble the technical file, draft the EU and UKCA Declarations of Conformity and review label and manual text.
- Representative pack. The finished file is handed over in the format EU Authorised Representatives and marketplaces expect, so appointment and listing approval are quick.
- Maintain. We flag standard revisions, directive changes and report expiry so the file stays current.
Validity, renewal & surveillance
The technical file must be retained for at least ten years after the last unit is placed on the market. There is no renewal date, but the file stops being valid the moment a harmonised standard is superseded, a component changes or a new regulation applies. National market surveillance authorities can request the file through the responsible economic operator and test products from the market. From 9 December 2026 the revised Product Liability Directive also makes the EU representative or fulfilment provider liable where no EU manufacturer or importer exists, which is why representatives insist on a reviewed file.
How Aaditech helps
Aaditech is an NABCB-accredited Type A inspection body for electrical equipment (ISO/IEC 17020:2012), led by former Directors of the Bureau of Indian Standards. We have handled more than 2,500 licences and registrations for Indian and foreign manufacturers, and we apply the same engineering review to EU files.
- Applicability review across CE directives, GPSR, UKCA and marketplace rules.
- Test report verification: lab accreditation and scope, standard edition, model and rating coverage, report age.
- Risk assessment written by engineers who know the product category.
- Technical file assembly and EU and UKCA Declaration of Conformity drafting.
- Label and instruction review including GPSR traceability text.
- Lab coordination in India and Europe for gap testing.
- Authorised Representative appointment support through established EU and UK providers.
We are not an EU Notified Body and we do not act as your EU Authorised Representative. Where either is required, we prepare you for it and manage the handover. Contact us with your product list and existing reports for a free gap check.
