Face masks, gloves and hygiene products

• Regulation (EU) 2016/425 — PPE
• Regulation (EU) 2017/745 — Medical Devices
• Regulation (EU) No 528/2012 — Biocidal Products for sanitisers
• Regulation (EU) 2023/988 — GPSR

Who has to appoint one

Manufacturers and sellers outside the Union placing masks, gloves and hygiene products on the EU market. The intended purpose splits the category: protecting the wearer is PPE, protecting the patient is a medical device, killing micro-organisms is a biocidal product, and simple cleaning is a consumer product.

Thresholds and exemptions

None. The 2020 experience produced extensive enforcement and the scrutiny has not relaxed, particularly on certificates from bodies not notified for the relevant Regulation.

What must appear on the label

For PPE: CE marking with the notified body number for Category III respirators, the standard reference, and the manufacturer and EU representative details. For medical devices: CE marking with the notified body number where applicable, the EC REP details, the UDI and the sterile or single-use symbols. For biocidal products: the authorisation number and the CLP information.

Marketplace fields

Marketplaces removed vast numbers of listings in this category and continue to check the notified body number against NANDO. Certificates from unlisted bodies are treated as fraudulent rather than as a documentation gap.

Documentation you must hold

EU declaration of conformity and technical documentation for the applicable regime, the EU type-examination certificate for Category III PPE with production surveillance, or the MDR technical documentation and notified body certificate for devices. Biocidal products need a product authorisation, an Article 95 listed active substance supplier and a safety data sheet.

Standards and testing

EN 149 for filtering half masks, EN 14683 for medical face masks, EN 455 for medical examination gloves, EN 374 for chemical protection gloves, and efficacy testing under EN 1500 and related standards for hand sanitisers.

Language requirements

Instructions, warnings and the meaning of markings in the language of each member state of sale.

When it applies

Before placing on the market. The emergency derogations that operated during the pandemic have all expired.

How long records are kept

Ten years for PPE documentation, and the MDR retention periods for devices.

What happens if you do not comply

Withdrawal, Safety Gate alerts and, where certificates are fabricated, criminal proceedings for fraud. Several member states prosecuted mask sellers after 2020 and those cases established the enforcement posture.

Who enforces it

Market surveillance authorities, medical device competent authorities, biocides authorities, customs, and notified bodies.

Where the boundary lies

The same physical mask can be PPE, a medical device or both depending on the claim, and dual certification is possible but requires both routes to be completed. A hand sanitiser is a biocidal product needing an authorisation, not a cosmetic and not a general consumer product, however it is marketed.

Questions we are asked

Is an FFP2 mask a medical device?

It is Category III PPE. A surgical mask is a medical device. A mask claiming both must satisfy both regimes, with both certificates.

Can we sell hand sanitiser as a cosmetic?

No. A claim to kill micro-organisms is biocidal and requires a product authorisation. Selling it as a cosmetic is a common and heavily penalised misclassification.