Information on the EU Regulations (MDR, IVDR)
On 13 March 2019, Brussels issued a corrigendum that you can download here:
For MDR: https://data.consilium.europa.eu/doc/document/ST-15409-2018-REV-1/en/pdf
You will find the corrections to the English version on p.38 ff.
For IVDR: https://data.consilium.europa.eu/doc/document/ST-15418-2018-REV-1/en/pdf
You will find the corrections to the English version on p.46 ff.
The European competent authorities elaborated a roadmap for implementing the MDR and IVDR in Europe that was published on 7 November 2017. The roadmap provides a high-altitude view of the steps involved in implementation and the work packages that the individual working groups have to deal with.
On the website of the European Commission you can find important links and information concerning the new Regulations on medical devices and IVD: