Commission published the common specifications to harmonise the practice of reprocessing of single use devices within health institution in those Member States where it is allowed.
Posted on 09.09.2020
The MDR allows reprocessing of single-use MDs to enable their safe re-use, as long as this is also permitted by national law.
Where national laws allow it, the reprocessing of single-use devices within a health institution in view of them being used within the same institution, can be performed only when the process follows clear procedures which are defined by the relevant Member State.
In order to harmonise the above procedures, a Common Specification which has recently been adopted by the Commission via an implementing regulation (Commission Implementing Regulation (EU) 2020/1207) sets specific requirements and procedures to be followed in terms of Quality Management Systems, labelling, traceability, vigilance, staff, premises and equipment, etc.
The procedures apply both in the case of reprocessing made in-house or sub-contracted to an external entity. In the latter case, there are also specific requirements related to the contractual arrangements between the health institution and the external reprocessor.