Self test medical devices are strictly regulated in the UK, having to comply with the requirements of the EU In-Vitro Diagnostic Directive 98/79EC (IVDD). All diagnostic tests sold in the UK and throughout the EU must comply with these regulations and carry the CE mark to show compliance. There are different classes of diagnostics and these are assessed according to risk. The IVDD ensures that all self test diagnostics are independently evaluated by a Notified Body such as BSi or TUV, prior to being CE marked and placed on the market. The regulation of self test kits in the UK is more stringent than laboratory diagnostics to ensure that the tests are easy to use by lay persons and provide reliable and easy to interpret results. Once a self test has been approved by a Notified Body and CE marked, the test can be freely sold within the EU without restriction, providing the instructions for use are in the language of the country it is marketed in.
The IVDD is currently undergoing transition to the In Vitro Diagnostic Regulations (IVDR) which will be mandatory in 2022 for all manufacturers and distributors of all classes of medical diagnostics. One of the key changes of the new IVDR will be to impose more responsibilities on distributors, including the requirement to have full traceability of products. One way for manufacturers and distributors to show compliance with the IVDR will be to have an externally audited certification to ISO 13485:2016, the Quality Management System for Medical Devices.
All SELFCheck products are CE marked according to the IVDD and assembled at our laboratories in North Wales according to a full ISO 13485:2016 quality management system, which is externally audited by UKAS accredited auditors to demonstrate compliance with the requirements of the IVDR. All batches of products have LOT numbers to ensure full traceability of components, and delivery notes contain details of lot numbers and expiry dates to ensure traceability of kits.
Technological innovations in in-vitro diagnostic techniques, as well as an effective regulatory environment, means that self test devices are evolving - becoming more reliable, easier to use and with clearer instructions and advice. Feedback from customers, opinion leaders and regulators will be important drivers for continued innovation.
Further information on our quality system, including copies of our ISO 13485:2016 and ISO 9001:2015 certification are available from our Regulatory Manager.