News
Tighter regulation for self-test kit distributors
Friday 5th August 2022
J R BIomedical Ltd
All self-test medical devices are strictly regulated in the UK, and EU.
Following brexit, since January 2021, all tests sold in the UK have to be registered with MHRA. Further, new regulations will also come into force on the 1st July 2023 and are likely to mirror those of the In Vitro Diagnostic Regulations (IVDR) currently in force within the EU.
Stricter legal requirements for distributors of self-test kits
One of the key changes of the new IVDR is that for the first time, responsibilities will be imposed on the distributor, as well as the manufacturer. For instance, it will be mandatory for distributors to have credible evidence of full traceability of products, suitable storage facilities and compliance with the IVDR standards, such as external audits and certification to ISO 13485:2016, the "gold international standard" quality management system for medical devices.
Ensuring public safety
The increased regulatory requirements for self-test kits will help ensure that medical devices are only supplied by distributors with the expertise and resources to ensure competent levels of vigilance, surveillance and technical support are implemented to protect public safety.
For further information on the regulation of self-test diagnostics can be found here
SELFCHECK self-test kits are assembled and distributed in the UK by 1st Health Products Ltd who are ISO13485:2016 certified for the design, development, assembly and distribution of in vitro diagnostic medical devices at our North Wales laboratories, and undergo annual external audits to the ISO13485:2016 standard by UKAS accredited auditors.
SELFCHECK are pleased to provide help and guidance for retailers and wholesalers to ensure systems are in place to comply with the new UK regulations.