English will still be an official language of the EU for Malta and Ireland when the UK withdraws. Since the notified bodies are required to be located within the EU, there will certainly be an impact on any notified bodies located in the UK (currently BSI is approved with a UK presence). When the UK is no longer considered a member state, BSI UK will no longer be able to act on behalf of the EUMDR to certify products. Many or most of the certified bodies accept English as a submission language, so it should not affect US companies for the translation of submission documents at this time.
Brexit is expected to also create additional bottlenecks around notified body approvals since there are a very low number of bodies approved. Bottlenecks are already expected by industry experts, since there are not enough notified bodies certified to manage the upcoming MDR submissions. The biggest impact of Brexit is likely to come in the form of additional submissions to the MHRA in the UK. The MHRA has set the same deadlines as the MDR for compliance periods (May 2020 and 2022). The UK is no longer a part of the EU as of January 31, 2020. However, during the transitional period for Brexit (which extends until December 31, 2020) more information should become clear on how Brexit will affect medical device regulations. To be fully prepared, medical device companies should plan for a parallel submission path and evaluate the role of their authorized representatives and/or manufacturers in the UK to determine future compliance.