Medical Mask Compliance Testing for EU & US Markets

Presented by China JJR Laboratory

This document provides a comprehensive explanation of the testing and certification requirements for epidemic prevention products—such as masks and protective clothing—when entering markets in the European Union, the United States, and China.

Mask Export to the European Union (EU)

Regulatory Changes in the EU

The EU has transitioned from the MDD (Medical Device Directive 93/42/EEC) to the MDR (Medical Device Regulation 2017/745). As of May 27, 2020, MDR officially replaced MDD. However, MDD certificates issued before May 26, 2020, will remain valid until May 26, 2024.

In the European market, masks are classified into two main categories: Personal Protective Equipment (PPE) for industrial use, and Medical Masks for healthcare applications.

Medical Masks

Certification pathways depend on whether the product is sterile or non-sterile:

- Non-Sterile Medical Masks: These do not require certification from a Notified Body. Manufacturers can self-declare conformity by preparing technical documentation, providing test reports, issuing a Declaration of Conformity (DOC), and appointing an EU Authorized Representative for registration.

- JJR Lab Solution: Under MDR, Class I, we assist clients with self-declaration procedures. Testing takes approximately 3–6 weeks, with expedited services available that allow shipment within 1 week.

- Sterile Medical Masks: These require full Notified Body involvement and a CE certificate. The process typically takes at least six months and includes sterilization validation, establishment of an ISO 13485 quality system, preparation of technical files, product testing, Notified Body audits, and EU registration.

Protective Masks

Protective masks must comply with the EU’s PPE Regulation. To export these products, the following documents are required: a type-examination report, technical file review, factory quality system audit, and a CE certificate issued by a Notified Body.

- JJR Lab Solution: According to EN149:2001+A1:2009, we can help obtain CE certification within 10 working days.

Mask Export to the United States (US)

The U.S. also differentiates between medical and industrial protective masks:

- Medical Masks are regulated by the FDA.

- Protective Masks are regulated by NIOSH.

Medical Masks

Classified under FDA regulation 878.404 as Class II medical devices, these masks require a 510(k) premarket notification. The process includes performance and biocompatibility testing, preparation and submission of the 510(k) dossier, FDA review and issuance of an approval letter, factory registration, and device listing.

- JJR Lab Solution: We assist clients in applying for FDA 510(k) clearance. The process typically takes 2–5 months, though expedited cases have been approved in as little as 2 months.

Protective Masks

NIOSH certification involves sending samples to a NIOSH-accredited lab (usually in the U.S.) for testing, submitting detailed technical documentation (including product drawings, descriptions, quality system records, and test reports), undergoing a factory inspection, and finally obtaining the certificate.

For all the above scenarios, JJR Laboratory in China provides full support with regulatory strategy, documentation, testing, and liaison with relevant certification bodies to ensure your products enter the EU or U.S. market efficiently and compliantly.