The UK Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency (MHRA) launched a long-await­ed pub­lic con­sul­ta­tion on the future recog­ni­tion of CE-marked med­ical devices in Great Britain. The con­sul­ta­tion was open until April 10, 2026.

Three pro­pos­als shap­ing the path forward

MHRA sought views on three tar­get­ed pro­pos­als designed to reduce reg­u­la­to­ry dis­rup­tion while main­tain­ing appro­pri­ate oversight. 

1. Extend­ing tran­si­tion­al arrangements

The first pro­pos­al would extend cur­rent tran­si­tion­al pro­vi­sions for devices cer­ti­fied under the EUMed­ical Devices Direc­tive (MDD). This aims to bet­ter align Great Britain’s time­lines with the EU’s tran­si­tion to the Med­ical Devices Reg­u­la­tion (MDR) and reduce the risk of sup­ply disruption. 

2. Indef­i­nite recog­ni­tion of MDR and IVDR devices

The sec­ond pro­pos­al con­sid­ers indef­i­nite recog­ni­tion of devices declar­ing com­pli­ance under the MDR and In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (IVDR). MHRA is ask­ing whether this should apply to all devices or only those that fall into the same—or lower—risk class as under UK MDR 2002. 

3. Inter­na­tion­al reliance (IR) for high­er­risk devices

The third pro­pos­al intro­duces an IR route for a small sub­set of CEmarked devices that would be clas­si­fied as high­er risk under UK MDR 2002 com­pared to MDR/ IVDR clas­si­fi­ca­tion rules. 

Source: Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

Search our web­site by key­word “Brex­it”