Brexit, EU MDR and Medical Device Risk Management

The EU MDR 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 EU Withdrawal Agreement Act and will not automatically apply in Great Britain.

ISO 14971:2019 - Application of risk management to medical devices is a global risk management standard that has just been updated to keep up with regulatory and technological changes in the medtech industry.

So what does this mean?

The provisions contained within the EU MDR 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 EU MDR.

Join this FREE webinar by PS Partnerships & Consultancy to understand more about the impact of Brexit on the medical device sector and how ISO 14971 can help you to meet your regulatory requirements.