Contents
1.Reprocessors shall have a technical documentation on its reprocessing activities which shall include:
(a)the procedures for controlling and periodically monitoring premises and equipment referred to in Article 4(5) and (6);
(b)any decision concerning the ability or lack of ability to reprocess a type of single-use devices.
Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.