PPE gloves compliance: Modules and Declaration of Conformity

Manufacturers of PPE gloves (as well as importers and distributors wishing to market products under their name or brand) must meet the compliance obligations of Regulation (EU) 2016/425 on Personal Protective Equipment (PPE), which repealed Directive 89/686/EEC, to obtain authorisation to place their products on the market.
PPE manufacturers are required to obtain a Module B certificate and a Module C2 (or Module D) certificate. These allow them to draw up Declarations of Conformity for single-use gloves, which are mandatory for placing the gloves on the market, and to affix the CE marking.
To meet these requirements, manufacturers must follow specific procedures.
One PPE gloves category,
one CE certification procedure
There are three categories of PPE (as described in Annex I of EU Regulation 2016/425):
- Category I: Minimal Risk
- Category II: Risks not covered by Categories I or III
- Category III: Risks causing fatal or irreversible damage
The manufacturer must follow a specific procedure (as outlined in Article 19 of Regulation EU 2016/425) to certify the single-use glove according to its assigned category:
- Category I:
- Module A: Self-certification procedure.
- Category II:
- Module B: EU type-examination certificate issued by a Notified Body (NB) whose identification number must appear underneath the CE marking. Module B certificates are valid for 5 years.
- Module C: Self-monitoring of conformity to type based on annual checks.
- Category III:
- Module B: EU type-examination certificate issued by a Notified Body (NB), whose identification number must appear underneath the CE marking. Module B certificates are valid for 5 years.
And, at the manufacturer’s choice, either:
- Module C2 (Product control): Conformity to type certificate based on random sample checks of products, issued by a Notified Body. The certificate is renewable annually and subject to audits.
- Module D (Production control): Conformity to type certificate based on monitoring the quality assurance system of the production process, involving annual audits conducted by a Notified Body.
The manufacturer must determine the PPE glove category before proceeding with the relevant certification procedure.
Why is a Notified Body required for PPE gloves?
For PPE gloves Category II and III, the manufacturer must engage a Notified Body (NB) to assess single-use gloves conformity before placing on the market.
Notified Bodies are designated by EU Member States. In the UK, for UKCA certification, the equivalent term is "Approved Person".
The manufacturer is free to choose the Notified Body (NB) that will evaluate its products, knowing that this NB must be independent of the manufacturer.
Upon manufacturer’s request, the Notified Body:
- Verifies the manufacturer's technical documentation (detailed in Annex III of the Regulation EU 2016/425) to ensure the PPE is adequately designed.
- Assesses manufacturing conformity (with the technical file information) through sample testing.
- Conducts tests to ensure the PPE meets essential health and safety requirements.
The manufacturer must determine the PPE glove category before proceeding with the relevant certification procedure.
The manufacturer must determine the PPE glove category before proceeding with the relevant certification procedure.
Following successful audits, the Notified Body issues the necessary certificates, authorising the manufacturer to affix the CE marking including the NB's identification number.
Module B, C2, and D:
What do they mean for gloves certification?
To be authorized to place Category III protective gloves on the market and to affix the CE marking to its products, the manufacturer must follow, for each of its products, a procedure to obtain beforehand from a Notified Body:
- An EU type-examination certificate (known as Module B).
- A certificate of conformity to the type (known as Module C2 or Module D) according to the manufacturer's choice.
Module B (EU type-examination certificate):
The EU type-examination certificate ensures that the PPE design complies with regulatory and technical requirements.
The Notified Body reviews the whole product’s technical file (technical documentation, assessment of the manufacturing conformity and samples test results).
If all requirements are met, the Notified Body issues the Module B certificate, valid for 5 years.
Module C2 (Product control for conformity to type):
As detailed in the Annex VII-article 2 of the Regulation EU 2016/425, the Module C2 focuses on product conformity through random inspections. The manufacturer must ensure consistent production quality and compliance with the type described in the Module B certificate.
A Notified Body is also required to conduct random product checks, and if the PPE meets the requirements, a Module C2 certificate is issued.
Annual inspections are mandatory for certificate renewal.
Module D (Production control for conformity to type):
Module D certifies that the manufacturer fulfills its obligations regarding:
- The application of an approved quality system for production (technical documentation is reviewed and the manufacturer's facilities are visited and evaluated during an audit).
- Final PPE inspection.
- Checks and tests "carried out before, during and after manufacture" as well as "the frequency with which they" take place.
The Notified Body conducts “surveillance audits” of the quality system, and may carry out “unannounced visits”, to ensure compliance.
If the system complies, the manufacturer receives a Module D certificate, which must also be renewed annually.
Single-Use gloves' Declaration of Conformity
Once Module B and Module C2 (or Module D) certificates obtained, the manufacturer must issue a Declaration of Conformity (DoC) for each single-use glove.
The DoC content is detailed in Annex IX of the Regulation EU 2016/425 and must be translated into the language (s) required by the EU Member State where the PPE is marketed.
Through the Declaration of Conformity, the manufacturer attests to the PPE gloves’ compliance with health and safety requirements. In addition, the PPE single-use gloves must be accompanied by a User’s Instruction leaflet.
All SHIELD Scientific Category III single-use gloves hold Module B and Module C2 certificates as confirmed by the Declarations of Conformity available on this site. Furthermore, all SHIELD Scientific gloves’ Module B and C2 certificates are available upon customers’ request.
Compliance with EU Regulation 2016/425 has always been one of the 3 SHIELD Scientific’s core pillars – our slogan had always been “Compliance, Comfort, Protection” - helping us to build a strong foundation of trust with our customers worldwide.
Contact a SHIELD Scientific representative today for more information on the certification of our Cat. III single-use gloves or to request a sample.
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