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Public Health

National rules on reprocessing of single-use devices

EU countries have the obligation to notify the European Commission of the national provisions on reprocessing of single-use devices introduced by Article 17(3) of MDR and on restrictions or prohibitions on reprocessing of single-use devices introduced by Article 17(9) of MDR. The Commission has the obligation to keep such information publicly available.

The Commission updates this page, based on the notifications received from EU and other EEA countries.

The following EU and other EEA countries do not authorise reprocessing of single-use devices on their territory:

  • Austria (AT)
  • Cyprus (CY)
  • Czech Republic (CZ)
  • Denmark (DK)
  • Estonia (EE)
  • Finland (FI)
  • France (FR)
  • Greece (EL)
  • Italy (IT)
  • Latvia (LV)
  • Lithuania (LT)
  • Malta (MT)
  • Norway (NO)
  • Romania (RO)
  • Slovakia (SK)

The EU countries listed in Table 1 authorise the reprocessing of single-use devices on their territory. The table lists those EU countries and specifies if other options from Article 17 of Regulation (EU) 2017/745 are applicable as well as if restrictions and prohibitions are defined at the national level for the reprocessing of single-use devices.

Table 1

COUNTRY

OPTIONS, RESTRICTIONS AND PROHIBITIONS

17(2)

Manufacturer obligations

17(3)

Common Specifications

17(4)

Outsourcing

17(9)

Restriction and prohibitions

Belgium (BE)

 

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Croatia (HR)

 

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Germany (DE)

 

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Ireland (IE)

 

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The Netherlands (NL)

 

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Sweden (SE)

 

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Legend:

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permitted

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not permitted

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established

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not established

 

The information available on this page reflect the notifications received up to April 2022.

Useful information

Reference to national legislation

Belgium:

Croatia:

Germany:

Ireland:

Netherlands:

Sweden: