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Focus on Regulation

Tag Archives: In vitro diagnostic medical devices

UK MHRA Publishes Guide to the New EU Medical Device and IVD Regulations

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published an interactive guide to assist companies with understanding the requirements of the new EU Medical Device Regulation (“MDR”) and In Vitro Diagnostic Medical Device Regulation (“IVDR”). The MDR and IVDR entered into force on 25 May 2017. Most of the requirements under the MDR

Medical Device Alert – Political Agreement Concerning the Text of the new Regulations on medical devices and in vitro diagnostic medical devices

Late on 25 May 2016, the Council of the European Union issued a press release to announce that the European Commission, the European Parliament and the Council had reached a political agreement concerning the text of the proposed Regulation on medical devices and the proposed Regulation on in vitro diagnostic medical devices. While this step