With the end of 2021 fast approaching, it is worth reflecting on a year that has seen a lot of regulatory changes. For many, the first challenge was Brexit on 1st January. This included the implementation of UK national processes, and Centrally Authorised medicines transitioning to UK PLGB licences, via the MHRA Submissions Portal. For Devices, the full implementation of the MDR has brought harmonisation of requirements / expectations, although the UK remains aligned with the MDD for UKCA marking – at least until they are next updated. The MDR brought with it Article 117 impacting Drug-Device Combination products, and how these will be managed in applications. And recently, the proposal to delay implementation of the IVDRs… As we all gather experience with these changes, we can look forward to what 2022 will bring. As always, at ESPL we are here to help you navigate the new procedures efficiently and effectively.