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.
A Notified Body is an organisation that has been designated by an EU member state (the designating authority) to assess whether manufacturers and their medical devices meet the requirements set out in legislation. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is the designating and competent authority. Following Brexit, from 1st January 2021, the regulation of IVDs in the UK will remain largely unchanged. Whilst EU members will be transitioning to the IVDR, the regulation of IVDs in the UK will continue to be governed by the IVDD.
Regulation of self tests is more rigorous than for hospital tests
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 relevant, reliable and easy to interpret results. Once a self test has been approved by a Notified Body and CE marked, the test may 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 Notified Body will check that the;
- instructions provided are easy to follow
- performance, safety and reliability of the device meets the requirements for its intended use
- device is manufactured according to established international standards for medical devices (ISO13485:2016)
- self test can be easily used and interpreted by laypersons
-and carry out annual on-site inspections of the manufacturing facilities, quality assurance system and product technical files.