Kemi Badenoch, MP for North West Essex, recently visited Hunter Scientific, a leading local SME specialising in high-quality medical and laboratory equipment that plays a pivotal role in both local employment and the UK’s global life sciences sector. During her visit, Mrs Badenoch toured the facility and engaged in detailed discussions with Managing Director Mark Rawe and the team about the mounting regulatory challenges facing UK manufacturers.
Hunter Scientific outlined its concerns over an uneven regulatory landscape in the UK medical device market. The company raised concerns that identical IVF products are reportedly misclassified overseas as Class 1 devices, whereas UK manufacturers are required to meet more demanding Class IIa compliance—creating a stark disparity in costs and market conditions.
In addition, Hunter Scientific highlighted the significant financial burden of compliance. The firm faces regulatory fees exceeding £100k—including a substantial portion incurred in 2024—and relentless audits, factors that together hinder innovation and competitiveness. Compounding these issues is the complexity of the MHRA’s Public Access Registration Database (PARD), which complicates product registration for laboratory technicians.
Commenting on the visit, Mrs Badenoch said:
"Hunter Scientific stands at the forefront of medical innovation, yet UK businesses like them are facing critical challenges in the medical device market.
“The MHRA and BSI must ensure UK SMEs have an even playing field with foreign competitors.”
Managing Director Mark Rawe added:
"Kemi’s visit offered a valuable opportunity to demonstrate how our SME, deeply rooted in the local community, not only supplies UK clinics but also exports to more than 30 countries worldwide, despite the challenging regulatory environment.
ENDS
