29 November 2019
On 25 November 2019, the European Commission published a new amendment to EU Regulation 2017/745. This amendment is currently in the planning phase but should soon be adopted definitively.
In particular, this amendment includes a deadline (26 May 2024) for the alignment of Class 1 Medical Devices, already compliant with Directive 93/42 and which must change class under the new regulation.
However, none of these Class 1 Medical Devices (in particular reusable surgical instruments, but also most software) need to be modified between now and 2024. The technical dossiers must include:
- The PMS (Post-Market Surveillance) plan and PMS report.
- Registration in the EUDAMED European database, which has also been rescheduled for May 2022.