Strictly Certified to DIN 13164:2022 & CE MDR Standards. Zero Customs Risks

Strictly Certified to DIN 13164:2022 & CE MDR Standards. Zero Customs Risks

Strict compliance with DIN 13164:2022 and CE MDR standards ensures zero risk during customs clearance.

In the European market, compliance is not merely a bonus; it is a fundamental prerequisite for market entry.

For automotive first aid kits and medical emergency kits, EU customs authorities closely scrutinize compliance with the DIN 13164:2022 standard, the EU MDR (Medical Device Regulation 2017/745), and CE certification requirements during the clearance process.

Any missing documentation, non-conformity with standards, or non-compliant product composition can lead to shipment delays, inspections, or even seizure of the goods.

DIN 13164:2022 — The Core European Standard for Vehicle First Aid Kits

DIN 13164 is a German industrial standard and a specification for vehicle first aid kits widely adopted across many EU countries.

The 2022 version (DIN 13164:2022) places particular emphasis on the following:

The kit's contents must be complete and strictly adhere to the prescribed list.

Quantities of medical supplies must meet minimum standards.

Basic protective items (such as gloves, dressings, bandages, etc.) must be included.

Packaging and instruction manuals must comply with EU regulations.

Product traceability must be ensured.

👉 During actual customs clearance, authorities prioritize checking:

Full compliance with the DIN 13164:2022 configuration standards.

Any omissions or substitutions may result in inspections or the detention of goods.

2.DIN 13164 is a German industrial standard and a specification for vehicle first aid kits widely adopted across many EU countries.

The 2022 version (DIN 13164:2022) places particular emphasis on the following:

The kit's contents must be complete and strictly adhere to the prescribed list.

Quantities of medical supplies must meet minimum standards.

Basic protective items (such as gloves, dressings, bandages, etc.) must be included.

Packaging and instruction manuals must comply with EU regulations.

Product traceability must be ensured.

👉 During actual customs clearance, authorities prioritize checking:

Full compliance with the DIN 13164:2022 configuration standards.

Any omissions or substitutions may result in inspections or the detention of goods....

3.

EU MDR and CE Certification Requirements

Under the EU Medical Device Regulation (EU MDR 2017/745), certain components within first aid kits are classified as medical devices, such as:

Sterile dressings

Bandages

Medical gauze

Disinfection materials

Consequently, the following requirements must be met: CE certification, Declaration of Conformity (DoC), ISO 13485 quality management system compliance, and batch traceability management.

👉 If this documentation is incomplete, customs authorities are highly likely to request additional information or suspend customs clearance immediately.