Please see the proposed update and introduction of new Common Specifications for Class D devices under the EU IVD Regulation.
Please let us know if you have any feedback on the proposals. Note that the consultation close 16th September, so BIVDA will require feedback by Close of Business 13th September. Remember that these will apply in Northern Ireland, and MHRA are likely to be monitoring these closely.
In vitro diagnostic medical devices – common specifications (europa.eu)
