Made outside the EU? Someone in the EU must answer for your PPE

Manufacturers of personal protective equipment (PPE) established outside the European Union must comply with certain requirements before placing their products on the EU market.

Even when PPE has valid EU type-examination certification (Module B) and, for Category III PPE, ongoing Module C2 or Module D conformity assessment, additional obligations apply under Regulation (EU) 2019/1020. Below we answer the questions manufacturers ask us most often.

Frequently asked questions

1. Do manufacturers outside the EU need an authorised representative in the EU?

Not necessarily. However, an economic operator established in the EU must be responsible for certain regulatory obligations. Under Article 4 of Regulation (EU) 2019/1020, this role may be fulfilled by:

• an EU-based importer;
• an authorised representative established in the EU and appointed through a written mandate;
• an EU-based fulfilment service provider, under certain conditions, where no other qualifying EU economic operator exists.

If a manufacturer sells PPE through an EU-based importer, a separate authorised representative is generally not required.

2. Is an EU economic operator still required if the PPE already has valid Module B and Module C2 or D certification?

Yes. EU conformity assessment and the appointment or identification of a responsible economic operator are separate regulatory requirements. A valid EU type-examination certificate and ongoing Category III conformity assessment do not replace the obligations under Article 4 of Regulation (EU) 2019/1020.

3. Can the notified body that certifies our PPE act as our EU responsible economic operator?

Not for the same PPE it assesses. A notified body performs independent conformity assessment activities and does not automatically become the manufacturer’s EU representative. Acting as an authorised representative for products it certifies would also create a conflict with the independence and impartiality requirements applicable to notified bodies.

4. What if we sell PPE directly to customers in the EU without an importer?

The manufacturer must ensure that a qualifying EU-based economic operator is responsible for the tasks specified in Article 4 of Regulation (EU) 2019/1020. Where there is no EU importer or qualifying fulfilment service provider, the manufacturer can appoint an EU-based authorised representative. This representative does not need to purchase, distribute or physically handle the PPE.

An authorised representative can be a natural person or a legal entity, provided they are established in the EU, have an appropriate written mandate and can fulfil the required obligations. A postal address alone is not sufficient.

5. Does this requirement also apply when selling PPE through a webshop or an online marketplace such as Amazon, eBay, AliExpress or Temu?

Yes. Selling PPE online does not remove the requirement for an EU-based responsible economic operator. An online marketplace does not automatically assume this role merely by facilitating a sale; in some circumstances, an EU-based fulfilment service provider may qualify.

For online offers directed at EU consumers, Article 19 of Regulation (EU) 2023/988 also requires the display of certain information, including the name, postal address and electronic address of the EU responsible economic operator where the manufacturer is established outside the EU.

6. Must the EU responsible economic operator be identified on the PPE, packaging or instructions?

Yes, but not necessarily in the user instructions. Under Article 4(4) of Regulation (EU) 2019/1020, the economic operator’s name or registered trade name or trademark and contact details, including its postal address, must appear on:

• the PPE itself;
• its packaging;
• the parcel; or
• an accompanying document.

Where the economic operator is also the importer, Article 10(3) of Regulation (EU) 2016/425 imposes specific identification requirements: the importer’s details must appear on the PPE or, where this is not possible, on its packaging or an accompanying document.

7. Must the EU responsible economic operator be named in the EU Declaration of Conformity?

No, not solely because it acts as the responsible economic operator under Regulation (EU) 2019/1020. The EU Declaration of Conformity for PPE must follow Annex IX of Regulation (EU) 2016/425: it must identify the manufacturer and, where applicable, its authorised representative, as well as the relevant notified body and conformity assessment procedures. An EU importer or other Article 4 responsible economic operator does not have to be added to the declaration merely because it fulfils that role.

8. Is the EU responsible economic operator the person who must keep the technical documentation in the EU?

Not exactly. The manufacturer remains responsible for preparing and retaining the technical documentation for 10 years after the PPE has been placed on the market. The EU responsible economic operator must verify that the required technical documentation and EU Declaration of Conformity have been drawn up, keep the declaration available for the authorities and ensure that the technical documentation can be provided upon request. The complete technical documentation does not necessarily need to be physically stored within the EU.

The responsible economic operator must also cooperate with market surveillance authorities and assist with appropriate corrective actions.

9. Does the notified body check whether we have appointed an EU responsible economic operator?

This is not a separate certification requirement under Modules B, C2 or D. The notified body assesses conformity according to Regulation (EU) 2016/425 and the applicable conformity assessment module; the existence and identification of the economic operator required by Regulation (EU) 2019/1020 are primarily market placement and market surveillance obligations. However, the notified body still assesses the product documentation, instructions and relevant markings within the scope of its conformity assessment activities.

10. Can we obtain EU PPE certification before appointing an EU responsible economic operator?

Yes. A non-EU manufacturer can apply for EU type-examination (Module B) and the applicable Category III conformity assessment without first appointing an EU authorised representative. However, before placing the PPE on the EU market, the manufacturer must ensure that the applicable requirements concerning an EU-based responsible economic operator are fulfilled.

Legal references and official guidance

1. Regulation (EU) 2016/425 – personal protective equipmentDefines the obligations of manufacturers, authorised representatives and importers, as well as the conformity assessment procedures and requirements for notified bodies. Relevant provisions: Articles 8–10 and 24; Annexes III, V, VII, VIII and IX.
2. Regulation (EU) 2019/1020 – market surveillance and compliance of productsArticle 4 establishes the requirement for an economic operator established in the EU and defines its responsibilities, including cooperation with market surveillance authorities and access to technical documentation. Relevant provisions: Article 4(1)–(4).
3. Regulation (EU) 2023/988 – General Product Safety Regulation (GPSR)Contains requirements for online and distance sales, including information that must be displayed in online product offers. Its provisions apply to PPE insofar as the relevant risks or aspects are not already covered by sector-specific EU legislation. Relevant provision: Article 19.
4. European Commission – guidance on Article 4 of Regulation (EU) 2019/1020 (Commission Notice 2021/C 100/01)Explains the practical application of Article 4, including the identification of responsible economic operators, distance sales and their obligations.
5. European Commission – the Blue Guide on the implementation of EU product rules 2022 (Commission Notice 2022/C 247/01)Guidance on EU product legislation, economic operators, conformity assessment, technical documentation and market surveillance.