Welcome to the Q2 2019 issue of our Life Sciences International Review. This issue covers new developments within Europe, Asia, and the United States in intellectual property, regulatory, pricing, and international trade, among others. Content for the newsletter was generated by Morgan Lewis lawyers. Many of these subjects will be updated in future issues as we will stay current with the continuous happenings and trends within the life sciences industry.
Brexit, Notified Bodies, and Medical Devices The House of Commons Library published a briefing paper on June 12 on the UK’s product standards and safety marking compliance in light of Brexit. In the absence of a deal, the European Union (EU) will no longer recognize UKbased notified bodies for CE-marking purposes. Post-Brexit UK notified bodies will become UK “approved bodies” and be able to grant “UKCA” marks to compliant products, including medical devices. Currently some 40% of all CE-marked medical device products use UK notified bodies. For a limited time manufacturers can use the CE mark on EU-compliant products on the UK market although, post-Brexit, relevant UK products for export to the EU will continue to require CE marking awarded by EU-based notified bodies. The situation has been exacerbated by the coming into force of the EU regulation on medical devices (2017/745/EU) (MDR) whereby few of the remaining such notified bodies are ready for CE-marking under the MDR (see Notified Body Crisis below).