The new European Union (EU) Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) are due to be implemented across the EU from May 2021.
In a poll conducted by Verdict to analyse whether the UK should implement the new EU MDR and IVDR into domestic legislation post Brexit transition, a majority 53% opined that it should be implemented.
Opinion remained divided on whether the UK should maintain the current UK medical device regulations or develop new medical device regulations, as an equal number of 24% of the respondents voted for either options.
The analysis is based on 204 responses received from the readers of Medical Device Network, a Verdict network site, between 07 December 2020 and 22 March 2021.
Medical device regulations in the UK post Brexit
The EU MDR was originally scheduled to be implemented in May 2020 but delayed due to the COVID-19 pandemic. The new regulations are only applicable to EU member states but not to the UK as they were not implemented during the Brexit transition period.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) is regulating the medical devices and in vitro diagnostic medical devices on the market in England, Wales, and Scotland under reformed regulations post Brexit transition.
The Independent Medicines and Medical Devices Safety Review, however, has highlighted the need for tough regulations for medical devices to ensure the safety of patients. New robust regulations are planned to be implemented under the proposed Medicines and Medical Devices Bill.
The MHRA is considering several factors such as international standards and global congruity in devising new systems of regulation. It is also in conversation with stakeholders in the healthcare and life sciences industry on the proposed bill to deliver a robust regulatory framework for scrutinising the medical devices reaching patients in the UK.