IVD Regulation changes in the United Kingdom in the post-Brexit era.

Until the IVD Directive 98/79/EC came into force in 2003 there had not been any single regulation for in vitro diagnostics across Europe. The majority of multinational suppliers worked to a quality management system, often introduced to achieve Food and Drug Administration (FDA) compliance to access the US market, and some individual countries had national regulation in place. The IVD Directive was the third in a series of ‘light touch’ medical device directives and had been adapted from the first medical device directive to make a rather ill-fitting regulation for IVDs – one could say it was ‘off the peg’ rather than bespoke tailoring.

As all EU directives are reviewed, usually about five years after adoption, it was expected that the IVD Directive would be adapted to fix its imperfections, such as the lack of ability to classify new tests according to their risk. However, this did not take place and instead the creation of the IVD Regulation took place over an extended period of time, finally being published in May 2017, but with an exceptionally extended transition phase of five years. This allowed for all the extensive work to be performed by regulators to provide the infrastructure for the Regulation and for industry to meet the huge amount of additional work to keep existing products on the market. It also gave the EU member states time to rescind the Directive in their national laws. A Directive is not law across EU member states so needs national law, whereas a Regulation is effectively EU law and so national laws are superfluous.

In his article entitled Potential impacts of the EU IVD-Regulation on clinical flow cytometry, published in this issue of Pathology in Practice, Maurizio Suppo elegantly and concisely covers the changes from moving from IVD regulation under the Directive to a Regulation. What he has not mentioned is the impact of the UK leaving the EU and how this will affect industry and clinical laboratories in the UK.