Reprocessing of Medical Devices - Implementing Regulation for Single-Use Devices

Recommendation

15/16 February 2024

Process Understanding - Live Online Training
Statistical Process Control (SPC) as a tool to get there

The reprocessing of single-use devices in the medical device sector is left to the EU Member States. However, only the national law of the respective member states must allow this. Now, an implementing regulation is available which describes common specifications for reprocessing.

If single-use devices are reprocessed and used in health institutions, the EU Member States permitting this may deviate from the requirements specified in the Medical Devices Regulation. This means that not all specifications regarding the obligations of the manufacturers have to be applied. One of the requirements for reprocessing is that it is done according to common specifications.

The "Implementing Regulation EU 202/1207 regarding common specifications for the reprocessing of single-use devices" comprises 13 pages and five chapters. It essentially describes

• Organisation of reprocessing and risk management (Chapter II)
• Procedures and steps of the reprocessing cycle (Chapter III)
• Quality Management, Annual Audit and Incident Reporting (Chapter IV)
• Traceability of the single-use device and final provisions (Chapter V)

The requirements described in the Implementing regulation also apply to reprocessors of single-use devices. The "Implementing Regulation EU 202/1207 concerning common specifications for the reprocessing of single-use devices" can be downloaded from the Eur-lex website.