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Importation of masks, goggles, and other protective equipment

In response to the COVID-19 pandemic, the EU has now issued a proposal to speed up the import of breathing masks, goggles and other protective equipment.

The Commission Recommendation (EU) 2020/403 of 13.03.2020 concerns

  • face masks / breathing masks
  • Protective suits
  • Safety glasses
  • Operating masks
  • Examination gloves
  • certain coats

Importation of face masks, goggles and protective suits

Disposable and reusable face masks, disposable and reusable protective suits, gloves and protective goggles are so-called personal protective equipment (PPE). Their placing on the market in the EU is regulated by Regulation (EU) 2016/425. Surgical masks, examination gloves and certain types of gowns, on the other hand, are medical products that are covered by Regulation (EU) 2017/745.

These regulations on PPE and medical devices regulate the design, manufacture and placing on the market of these products. They also regulate safety requirements that these goods must meet in order to be considered safe for the user. The annexes set out the essential health and safety requirements that personal protective equipment and medical devices must meet in order to be placed on the market and freely circulate throughout the EU market.

The Regulations also provide for conformity assessment procedures or declarations of conformity. For example, personal protective equipment in category III (protection against harmful biological agents) must undergo various conformity assessment procedures. For each conformity assessment procedure, conformity assessment by an independent third party body is required.

Import of protective equipment and medical devices under facilitated requirements

In order to prevent bottlenecks in personal protective equipment due to COVID-19, the proposal now allows:

  • Market surveillance authorities can release personal protective equipment and medical devices without CE marking for import into the EU if they consider that the products comply with essential health and safety requirements.
  • In this respect, personal protective equipment may already be placed on the market for a limited period of time or during the conformity assessment procedure. On the other hand, market surveillance authorities should focus on non-compliant personal protective equipment or medical devices which pose a serious risk to the health and safety of the user.
  • It was also ordered that all notifying bodies should give priority to conformity assessment for personal protective equipment.

This will not invalidate the existing rules on the conformity of PPE or medical devices, but will postpone their control. Businesses should therefore ensure that all imported products comply with the rules in order to avoid adverse measures.

Accelerated clearance for medical devices and protective equipment

For priority customs clearance of goods needed in the Corona crisis, the customs authorities have now emphasized that a new document coding system has been available since 27.03.2020:

9DFA “Import of medical supplies due to the corona situation”

This should definitely be used when the following products are introduced:

  • medical mouth and nose protection
  • Gloves
  • medical protective gowns, coats and suits
  • Safety glasses / Face shields
  • Bonnets
  • Disinfectants

This is the only way to ensure rapid customs clearance.

Attorney Dr. Tristan Wegner

Ihr Ansprechpartner

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