Your risk assessment must be updated as actions are taken to mitigate risks and as new risks are identified and controlled. Please advise your inspector of any significant new risks and the actions you take to mitigate them, especially if you think they may also have implications for other centres.
Please also consider your communications strategy re. EU exit. It is likely that concerned patients will need to be assured. The information you provide and how you deliver it needs to be carefully considered so that you can allay your patients’ concerns at the earliest stage possible.
On 15th February Guidance was issued on Quality and safety of human organs, tissues and cells if the UK leaves the EU without a deal. This provides an outline of what to expect in relation to Quality and safety, Single European Code, and Reproductive cells if the UK leaves without a deal. We will be issuing further information on this in Clinic Focus over the next few months.
Finally, the Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019 were passed in the House of Lords on 7 February 2019. In March we will provide details of what changes will be made based on these Regulations.
Publication date: 9 April 2026