The three current UK-approved bodies have been joined by DEKRA Certification UK, according to the Medicines and Healthcare Products Regulatory Agency (MHRA), enhancing the UK’s capacity to handle conformity evaluations for medical devices. As the first institution to accomplish the new designation procedure, DEKRA is now authorised to carry out evaluations of general medical equipment, or Part II designation.
An approved body is a group that has been given permission by the MHRA to check whether manufacturers and their medical devices meet the requirements set out in the UK Medical Devices Regulations 2002. Manufacturers must submit an application to a UK-approved organisation, with the exception of the absolute lowest-risk devices. Their products can only be sold in England, Wales, and Scotland after receiving UK Conformity Assessed (UKCA) certification.
The goal of the MHRA’s thorough assessment process is to make sure that any organisations that wish to certify medical devices are stable, capable of conducting fair and objective evaluations, have a suitable quality management process in place to support them, have the resources to conduct the evaluations, and have mechanisms and ongoing credentials in place to comply with the relevant regulatory requirements. The recognised authority will give the necessary certification following an adequate evaluation, enabling producers to apply the UKCA logo to their products before releasing them onto the market.
This is a huge milestone in their commitment to ensuring individuals all across the UK get access to the high-quality medical equipment they need to protect their health, said Dr. Laura Squire who is the chief healthcare quality and access officer at MHRA.
The growth of the UK’s medical device regulatory framework depends on approved organisations, which play a crucial role in the supply of medical equipment. The teams have put in a tremendous amount of effort to get to this point, and this has been a huge piece of work, she continued.
An additional six organisations are currently through the assessment process, while numerous other organisations are actively engaged in the process of getting prepared to send their initial submission.