28/03/23 (Agence Europe) – The European Commission published, on Tuesday 28 March, a document providing guidelines to stakeholders, mainly device manufacturers, on the practical aspects of the new rules for medical devices and in vitro diagnostic medical devices. The Commission document provides information on the practical consequences of the extension and its modalities. The document also addresses several possible situations for stakeholders. The Commission had submitted a proposal ,on Friday 6 January, consisting of short-term measures to avoid shortages of devices during the transition period to the new regulations EU/2017/745 and EU/2017/746 (see EUROPE 13094/1). The European Parliament had adopted, under urgency procedure, the amending regulation on Thursday 16 February (see EUROPE 13123/6). The Council of the EU unanimously finalised the adoption of the text on Tuesday 7 March (see EUROPE 13136/32). Link to the document: https://aeur.eu/f/635 (EV)