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European Union
Commission Implementing Regulation (EU) 2020/1207
Chapter II
Article 9
2.
(a)

Commission Implementing Regulation (EU) 2020/1207

In forceThis text since 9 Sept 2020law://eu/reg/2020/1207/art_9__para_2__pnt_a@2026-11-11

Version in force onWhereEuropean Union

Contents

1. Reprocessors shall have a technical documentation on its r…
2. Reprocessors shall also have a technical documentation spe…
3. The technical documentation specific to each model of sing…
4. The technical documentation shall be kept for 10 years aft…

Contents

1. Reprocessors shall have a technical documentation on its r…
2. Reprocessors shall also have a technical documentation spe…
3. The technical documentation specific to each model of sing…
4. The technical documentation shall be kept for 10 years aft…

(a)the results of the determination of the reprocessing cycle and procedures referred to in Article 7;

Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.

Key facts

Type: Implementing regulation · Commission Implementing Regulation (EU) 2020/1207 · EEA relevant
Adopted: 19 Aug 2020
In force: 9 Sept 2020
Applies from: 26 May 2021
Made by: Directorate-General for Health and Food Safety, European Commission
Official: EUR-Lex 32020R1207 · ELI

Topics

EU Member State health legislation marketing standard medical device non-durable goods product safety risk management safety standard technical specification used goods Internal market - Principles Medical devices

History · 1 version

9 Sept 2020Reading

Connections

Cites 1: this act

Defined terms · 3

Show every defined term

external reprocessor
means the entity reprocessing single-use devices at the request of a health institution;
reprocessing cycle
means a cycle that includes all reprocessing steps applied to a single-use device to ensure that the safety and performance of the reprocessed device is equivalent to that of the original device.
reprocessor
means the health institution and the external reprocessor reprocessing single-use devices;

eu/reg/2020/1207