The European Commission issued the following communication on 10th January: “Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products.”
This document is not written specifically for the medtech industry but for all sectors, outlining the principles for the withdrawal of the UK from the European Union. The medtech sector has an additional challenge: 30th March 2019 is the current date when UK Notified Bodies will cease to be able to operate as EU-recognized Notified Bodies. This deadline occurs during the EU’s transition to the Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR). While this creates additional complexity for the medical technology sector, it also means that UK Notified Bodies have had to start their planning process earlier than organizations located elsewhere in Europe.
UL has been in discussions with the Health Protection Regulatory Agency (HPRA) in Ireland regarding the establishment of a medical device and IVD Notified Body to support existing UL customers and prepare for the transition to the new Regulations.
UL will be making further announcements in the coming weeks with details of our future plans to continue supporting customers in their MDR and IVDR transition and compliance efforts.