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)
- Bulgaria (BG)
- Cyprus (CY)
- Czech Republic (CZ)
- Denmark (DK)
- Estonia (EE)
- Finland (FI)
- France (FR)
- Greece (EL)
- Hungary (HU)
- Italy (IT)
- Latvia (LV)
- Liechtenstein (LI)
- 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) |
 |
|
|
 |
| Croatia (HR) |
 |
|
|
|
| Germany (DE) |
|
|
|
|
| Iceland (IS) |
|
|
|
 |
| Ireland (IE) |
|
|
|
|
| Poland (PL) |
(making available or further reuse of reprocessed single-use devices in Poland is prohibited) |
|
|
|
| Portugal (PT) |
|
|
|
|
| The Netherlands (NL) |
|
|
|
|
| Spain (ES) |
|
|
|
|
| Sweden (SE) |
|
|
|
|
Legend:
|
| permitted |
| not permitted |
| established |
| not established |
The information available on this page reflect the notifications received up to May 2024.
Useful information
Reference to national legislation
Belgium:
- 22 December 2020 – Law on medical devices (FR)
- 12 May 2021 – Royal decree implementing the law of 22 December 2020 on medical devices (FR)
Croatia:
- 5 November 2018 - Law on the Implementation of Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on In vitro Diagnostic Medical Devices (HR)
Germany:
- 21 April 2021 - Ordinance on the creation, operation and use of medical devices (Medical Device Operators Regulation - MPBeBetriebV) (DE)
Iceland:
- 26 May 2021 – Act on medical devices No 132/2020 (EN)
- 9 September 2021 – Regulation on reprocessing of single-use medical devices No 1154/2021 (IS)
Poland:
- 7 April 2022 – Act on medical devices, Journal of Laws of the Republic of Poland, Pos 974 (PL)
Portugal:
- 5 April 2024 – Decree-Law nr 29/2024 (PT)
Ireland:
- 25 May 2021 - Medical Devices Regulations 2021, S.I. No. 261 of 2021 (EN)
Netherlands:
- 24 October 2019 – Act containing rules on the safety and quality of medical devices (Medical devices act), Staatsblad 2019 400 (NL)
- 24 April 2020 – Decision containing rules on the reprocessing and further use of single-use devices within Article 17 of Regulation (EU) 2017/745 and further rules on the use of medical devices (Medical devices decision), Staatsblad 2020 130 (NL)
Spain:
- 21 March 2023 - Real Decreto 192/2023, de 21 de marzo, por el que se regulan los productos sanitarios (ES)
Sweden:
