UK regulators name 3 approved bodies to ease device certification bottleneck
A Leap Forward in Easing the Certification Bottleneck and Ensuring Patient Safety in the United Kingdom
The Medicines and Healthcare Regulatory Agency (MHRA) has recently taken a pivotal step that could significantly alter the landscape of medical device certification in the United Kingdom. By designating three more approved bodies—TÜV SÜD, Intertek, and TÜV Rheinland UK—for the certification of medical devices, the MHRA has not only eased the existing bottleneck but also laid the groundwork for a more robust healthcare ecosystem.
You might recall that the need for additional approved bodies became pressing after Brexit. The UK's detachment from the European Union meant manufacturers of all but the lowest-risk devices had to apply for UK Conformity Assessment (UKCA) certification from an approved body. These approved bodies essentially took over the role previously performed by EU notified bodies, which issued CE marks for devices sold within the European Union. The MHRA's recent move directly responds to this capacity shortage, which led the government to stagger the transition from CE marks to UKCA certification.
Before this designation, the MHRA had automatically moved the UK's three existing notified bodies—BSI, SGS, and UL—to the approved body scheme when the country parted ways with the European Union. The pace of adding new bodies had been slow, with the UK affiliate of DEKRA becoming the first new approved body for medical devices nearly a year ago. Therefore, the latest addition of TÜV SÜD, Intertek, and TÜV Rheinland UK is a monumental stride. It's worth noting that TÜV Rheinland UK has also been empowered to assess in vitro diagnostic (IVD) products, an area where capacity has been notably lagging.
Laura Squire, the chief healthcare quality and access officer at MHRA, hailed this development as "almost doubling capacity for medical device assessment in the UK." While the exact number of applications each approved body can handle remains undisclosed, the move undeniably alleviates a long-standing concern. Two years ago, the Regulatory Horizons Council identified the "lack of capacity in approved bodies within the UK" as a risk to patient safety and access to devices. The government subsequently accepted recommendations to address these bottlenecks, notably the shortage of approved bodies, and took mitigating steps to ensure the supply of products after the transition to UKCA.
This development is not just a bureaucratic reshuffling; it's a lifeline for manufacturers. The concerns that led to this decision were not merely administrative but were deeply rooted in patient safety and access to essential healthcare products. The government's decision to continue accepting devices with CE marks through 2028 or 2030, depending on the regulation, further underscores its commitment to ensuring that you are not left in a lurch.
The MHRA's designation of additional approved bodies is a significant milestone in the UK's healthcare journey post-Brexit. It addresses critical bottlenecks, ensures a smoother transition to UKCA certification, and prioritises your safety and access to medical devices. As the UK navigates its new path, this move is a testament to the country's unwavering focus on healthcare quality and patient well-being.
Source: MedTech Dive