We had already pointed out in the past few days that the Medical Devices Regulation will not be applicable from 26 May 2020 in view of the pandemic and pointed out legal ways to postpone it.
Today, Stella Kyriakides, the EU Commissioner for Health, announced that the start of validity of the MDR is to be suspended by one year. The EU Parliament and the Council are to be dealt with the postponement at short notice. What this means in detail and how it will affect upcoming procedures for new products at the current Notified Bodies is not yet known. A document is currently being prepared in the EU. We will keep you informed and will be happy to answer any questions.