Die deutsche Medizintechnik-Industrie / SPECTARIS Jahrbuch 2021/2022

36 Gastbeitrag Internationale Märkte | Interview on our new trading relationship Interview on our new trading relationship Future perspectives for medical devices in the United Kingdom market for the SPECTARIS yearbook medical devices K enan Poleo joined the British Embassy in Berlin as Her Majesty’s Deputy Trade Commissioner for Europe in April 2019. As one of the 3 senior commercial diplomats in Europe, he and his teams focus on providing opportunities for the United Kingdom (UK) businesses across Europe and for European businesses to grow in the UK. His previous roles include Head of Global at Innovate UK, the UK’s innovation agency, supporting business-led innovation and international collaboration, and Regional Director for the UK Science and Innovation Network for Europe, Russia and Turkey, also based at the British Embas- sy in Berlin. He held numerous senior positions across the UK government including Deputy Director of European Energy and Environmental Legislation, Deputy Director UK Manufacturing Strategy and Assistant Director Chemicals Industry and Civil Contingencies. “Before we focus on the future, just a quick point about the past. The UK’s exit from the EU brought challenges for companies both in the UK and the EU. From your perspective, what were the most challenging topics for companies?“ I would say that the biggest challenge was around uncertainty about the outcome of negotiations for the industry. I do think that by us in the UK and Germany working together, we managed to ensure a high degree of readiness for both UK and German firms trading. We know that companies, like all of us, have been dealing with huge challenges due to the pandemic. Challenges for their sup- ply chains, their people and their survival. So we’ve tried to be pragmatic and have listened to business who asked us for more time. The UK government implemented a phased approach in- troducing border controls to give firms more time to adjust. On the regulatory side, the UK also implemented various “standstill” arrangements, including around the use of the UKCA marking. It’s only fair to recognize that such a change to trading conditions would be difficult in any circumstances. But by working togeth- er, and particularly by maintaining a close and open dialogue with the industry, we’re in a good place going forward. I am optimistic that we can continue to work with Germany and the EU to tackle upcoming challenges, and really take advantage of inevitable opportunities at the intersection of biopharma, med- ical technologies and big data. “With the ‘Medicines and Medical Devices Act 2021’ the UK has finalised and implemented legislation that will shape the future of the medical device industry in the UK. What does this Act do?“ The Medicines and Medical Devices Act will put in place the tools necessary for the UK to achieve our Government’s vision for a world-leading, dynamic system of medicines regulation. This will allow the UK to continue benefiting from the opportunities brought by progress in the medicine sector and maintain com- petitiveness in this space. It will ensure the UK to remain at the forefront of the global life sciences industry. It allows our regulators to go even further in developing innovative regulation. This will cement our ability to enable early access to cutting-edge technologies and break new ground in complex clinical trials. “The UKCA mark is required for all devices after June 30, 2023 – what do German companies need to know about this?“ The UKCA marking is a UK product marking used for certain goods, including medical devices, being placed on the UK mar- ket. UKCA (UK Conformity Assessed) marking is a new UK prod- uct marking that is used for goods being placed on the market in Great Britain (England, Wales and Scotland). It covers most goods, which previously required the CE marking, known as Kenan Poleo British Embassy Berlin Deputy HM Trade Commissioner for Europe and Counsellor International Trade, Germany www.gov.uk/dit