On Wednesday 25 May the EU institutions reached agreement on the draft texts for the revised Medical Devices Regulation and In Vitro Diagnostics Regulation, which will together replace the existing three Directives regulating devices, active implantable devices and in vitro diagnostics.
The agreement brings to a close the trilogue negotiations between the Council, Commission and Parliament on the draft texts of the two new Regulations. Agreement was reached in the tenth trilogue meeting following the negotiations being stretched out from the five meetings originally planned when it proved challenging to reach agreement on certain key provisions. It is thought that the main sticking points were: the scrutiny provisions relating to high-risk devices, reprocessing of single-use devices and counselling in relation to genetic testing.
This does not, however, represent the end of the process for creating a new EU regulatory framework for devices and diagnostics. The draft texts now need to be approved by the Council's Permanent Representatives Committee and by the Parliament's ENVI committee, with these steps expected to be completed in July. Following this, the draft texts will be subject to translation into all of the official languages of the EU, with the final steps being adoption by votes in each of the Council and the Parliament.
Many aspects of the final effect of the Regulations will still need to be agreed following adoption, as the texts leave much detail to be set by implementing and delegated acts.
The Council’s press release announcing the agreement on the draft texts can be found here.