EU MDR/IVDR The United Kingdom has adopted a final version of a regulatory framework for medical devices to be in force after Brexit. The new legislation prescribes the approaches to be applied with regard to the regulatory procedures associated with placing medical devices on...
EU MDR/IVDR The Medicinal and Healthcare products Authority (MHRA) has published an updated version of the guidance describing the new medical device regulations related to Brexit. In particular, the amended document provides additional details regarding the way medical devices...
Europe The European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) issued detailed information on Brexit to assist medical device manufacturers in dealing with issues related to changes associated with the transition period. Due to...
EU MDR/IVDR The British Standards Institution (BSI) United Kingdom (UK) has been officially designated as the first notified body (NB) under the Europe Union’s (EU) new Medical Device Regulation (MDR). This is the first NB to be listed in the European Commission’s New Approach...
Europe The final stages of the U.K.’s withdrawal from the European Union are quickly approaching, which means many critical things for the pharmaceutical and medical device industries. To facilitate the preparations drugmakers must make to remain in compliance with...
