Module C2 in practice: how production surveillance of Category III PPE works

For Category III personal protective equipment, obtaining an EU type-examination certificate (Module B) is only the first half of the route to the CE mark. Because Category III PPE protects against risks that can cause death or irreversible harm, the Regulation also requires ongoing oversight of production — and one common way to provide it is Module C2.

Module C2, set out in Annex VII of Regulation (EU) 2016/425, is “conformity to type based on internal production control plus supervised product checks at random intervals.” In plain terms: the manufacturer runs its own production control, and a notified body periodically checks that what comes off the line still matches the certified type.

The manufacturer’s part. The manufacturer must take all the measures needed so that the manufacturing process ensures the homogeneity of production — that every item conforms to the type described in the EU type-examination certificate and to the applicable essential health and safety requirements.

The notified body’s part: product checks. The notified body selects an adequate statistical sample of the finished PPE at a place agreed with the manufacturer — randomly, from available stock, representative of the certified range. The samples are examined and tested against the relevant harmonised standard (or equivalent technical specifications) to confirm they are still as type-examined.

Checking homogeneity. At least once a year, the notified body also verifies that production remains homogeneous, using one of several routes:

• an on-site review of the company’s production and test records;
• an on-site audit of the production control;
• sufficient samples taken to evaluate homogeneity;
• or smaller samples submitted through the year, based on production information.

If the checks reveal that production is not homogeneous, or that the PPE no longer conforms to the certified type, the notified body takes measures appropriate to the fault and informs the notifying authority. The notified body provides a test report, which the manufacturer keeps at the disposal of the national authorities for ten years after the PPE is placed on the market.

Can it be done remotely? Yes. A notified body may fulfil the Annex VII (Module C2) requirements through remote sampling — for example by video conference — where this is risk-appropriate. It is at the notified body’s discretion and is documented with a risk assessment. It also meets the Regulation’s requirement that notified bodies avoid unnecessary burdens on manufacturers (Article 32(2)) — saving you the cost of on-site visits.

How GÉPTESZT handles it. As notified body NB 2233, GÉPTESZT performs Module C2 (and Module D) for Category III PPE. With auditors close to production and the option of remote checks where appropriate, we keep surveillance thorough but cost-efficient — so your certified product stays compliant batch after batch, without unnecessary expense.

This article summarises how Module C2 works in practice, drawing on Regulation (EU) 2016/425 (Annex VII) and the notified bodies’ Recommendations for Use (RfU 00.007 and PPE-R 00.081).