PPE certification for non-EU manufacturers
Your buyers in the EU ask for a CE marking and an EU type-examination certificate — and the certificate must come from a notified body inside the European Union. The manufacturer, however, can be anywhere in the world. This page explains how the procedure works when your factory is not in the EU.
How the remote procedure works
- Enquiry — you tell us the product, its intended protection and target standard; we confirm scope, the sample list and the documentation checklist.
- Documentation review — technical file in English, exchanged electronically: drawings, material data, user information, risk analysis.
- Samples by courier — you ship the agreed samples to our Budapest laboratory.
- Testing and assessment — testing against the harmonised standard and assessment of the technical file.
- EU type-examination certificate (Module B) — issued by BIMEO as Notified Body 1524; for Category III PPE, ongoing conformity (Module C2 or D) follows.
There is no requirement to visit Hungary at any point of a Module B procedure — manufacturers from Pakistan to the United Kingdom complete it entirely remotely.
One certificate, two markets
Since October 2024 the United Kingdom recognises CE marking for PPE on the Great Britain market indefinitely. An EU type-examination certificate from an EU notified body therefore supports selling both to the EU-27 and to Great Britain — one procedure, both markets. (Northern Ireland follows EU rules under the Windsor Framework.)
Proven from outside the EU
Manufacturers outside the EU already hold valid BIMEO certificates — among them a Karachi glove manufacturer with 19 certified model families, and further holders in Serbia, Bosnia, Turkey and the United Kingdom; on the laboratory side, clients extend to India and China. They are part of close to 500 valid EU type-examination certificates issued by BIMEO and in force as of July 2026 — every one listed in the Hungarian notifying authority's public register. The remote procedure described above is not a promise: it is how these certificates came to exist.
Why a Central European notified body?
- You talk to the people doing the work — assessors and laboratory engineers, not an account queue;
- laboratory and notified body under one roof in Budapest, with a testing heritage going back to 1949;
- English-language procedure end to end: documentation, correspondence, certificate;
- verifiable status — check BIMEO (Notified Body 1524, Regulation (EU) 2016/425) in the European Commission's notified-body register.
Frequently asked questions
Can a manufacturer outside the EU hold an EU type-examination certificate?
Yes. Regulation (EU) 2016/425 places no restriction on where the manufacturer is established. The certificate is issued to the manufacturer named in the technical documentation, whether the factory is in India, Turkey, China, the UK or anywhere else. What matters is that the notified body issuing it is designated in the EU.
Do we need an EU authorised representative to get certified?
Not for the certification itself. Under Regulation (EU) 2016/425 appointing an authorised representative is optional for PPE. When your products are placed on the EU market, your importer or distributor carries defined obligations — we can explain how the roles fit together for your setup.
How do samples and documents reach you?
Technical documentation is accepted in English and exchanged electronically. Test samples are sent by courier to our Budapest laboratory; we confirm the required sample quantities per standard before you ship, so one shipment is normally enough.
Does a CE certificate also cover Great Britain?
As of 2026, yes for PPE: the UK recognises CE marking for PPE placed on the Great Britain market indefinitely (Product Safety and Metrology etc. (Amendment) Regulations 2024). One EU type-examination therefore serves both the EU and GB. Verify the current status on gov.uk before relying on it for a specific product.
How long does EU type-examination take?
It depends on the product, the completeness of the technical documentation and laboratory scheduling — the fastest procedures are the ones that arrive with complete documentation and the right samples. Send the product details through our enquiry form and we respond with a concrete scope, sample list and realistic timeline.
Start a certification enquiry
Tell us which product needs EU type-examination and against which standard — we will explain the procedure steps and the documentation required.
Start an enquiry