In case you missed it … a chance to watch PS Partnerships’ very own Paul Shipton‘s presentation ‘A storm brewing: Medical Device Regulations (EU MDR) and Directives in Europe and Great Britain‘.
The EU Medical Device Regulations will apply fully in EU Member States from 26th May 2021 … but as they take effect after the end of the Brexit transition period they will not be EU law automatically retained by the Withdrawal Agreement Act and will not automatically apply in Great Britain.
The provisions contained within the Regulations will not be transposed into law in the UK and will not be implemented (apart from Northern Ireland who will adopt MDR EU). The UK will carry on with the Medical Device Directive 93/42/EEC 1993 (EU MDD) which is given effect in UK law through the Medical Devices Regulations 2002 (UK MDR 2002).
However, on the horizon is the Medicine and Medical Devices Bill which builds on UK MDR 2002 to give added protection to patients and increase the scrutiny of medical devices that reach the UK. It is thought that this will strengthen the UK MDR 2002 and bring it closer to the EU Medical Device Regulations.
Watch this recording of PS Partnerships’ recent webinar to understand more about the impact of Brexit on the medical device sector.