On 19 August the European Commission issued the implementing regulation 2020/1207 establishing common specifications for the reprocessing of single-use medical devices under the Medical Device Regulation (MDR). It enters into force on 29 August 2020 and will fully apply on date of application of the Medical Device Regulation 2017/745, i.e. 26 May 2021.
Under MDR, single-use devices may be reprocessed where permitted by national member state law. Member states may also determine what rules they will apply to single-use devices reprocessed and used within a health institution, so long as the reprocessing is performed in accordance with the common specifications laid out in the regulation.
This implementing regulation 2020/1207 is aimed mainly at health institutions that chose to reprocess devices in-house, or to contract out their reprocessing, and at reprocessors themselves.
The implementing regulation 2020/1207 lays down requirements related to reprocessing of single-use medical devices and covers elements such as:
- Organisation of reprocessing and risk management (including e.g. number of reprocessing cycles and Technical Documentation
- Procedures and steps of the reprocessing cycle (including e.g. labelling and Instructions For Use)
- Quality management system, annual audit and reporting of incidents
- Traceability of single-use device
What does this mean to you?
If you reprocess single-use medical devices you will have to familiarise yourselves with this regulation. You will then have to determine if you are able to meet the requirements laid down in the implementing regulation 2020/1207 establishing common specifications for the reprocessing of single-use medical devices under the Medical Device Regulation (MDR).
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.