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. Already have test reports? Send them first — we assess what can be used before any new test is ordered.
How the remote procedure works
- Enquiry and scope check — you tell us the product, its intended protection, the target standard and class, and your markets; we confirm whether it falls within our designation.
- Existing reports and documentation — send the test reports and certificates you already hold, together with the technical file (in English, exchanged electronically). Already paid for testing? Send those reports before you order new tests: how existing test reports are assessed.
- Remaining tests — we identify which tests, if any, are still required, and which of them run in our own laboratory.
- Quotation and test plan — covering only what is still needed, with the sample list and the documentation checklist.
- Samples by courier — you ship the agreed samples to our Budapest laboratory.
- Testing and assessment of the technical documentation — drawings, material data, user information, risk analysis.
- Certification decision — where the type meets the applicable requirements, BIMEO issues the EU type-examination certificate (Module B) as Notified Body 1524. For Category III PPE, Module C2 or D is also required — depending on the product scope, it may be provided by our partner notified body GÉPTESZT (NB 2233).
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 and Herzegovina, Turkey and the United Kingdom; on the laboratory side, clients extend to India and China. Every one of their certificates is listed in the Hungarian notifying authority's public register. The remote procedure described above is how these certificates were obtained.
Why work with BIMEO?
- You talk to the people doing the work — assessors and laboratory engineers, not a service desk;
- 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: the certificate is issued to the manufacturer wherever it is established, and under Regulation (EU) 2016/425 appointing an authorised representative is optional. To place PPE on the EU market, however, an economic operator established in the EU must be responsible for the product — in practice your importer, an authorised representative or, in certain cases, a fulfilment service provider (Regulation (EU) 2019/1020, Article 4). 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.
Further reading
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