Brace yourself: New UK medical device regulations set to sweep self-test kit ranges off the market!
Monday 24th July 2023
With new UK medical device regulations just around the corner, it is now more important than ever that multiple retailers consider the impact on self-testing kits, and take action to ensure continuity of supply.
Until the UK left the EU following Brexit, the regulations applying to professional laboratory tests and self test kits, were the EU regulations, known as the In Vitro Diagnostic Directive 98/79 EC (IVDD). These EU regulations were updated in 2017, with a 5 year transition period, as reform was greatly needed to protect patient safety by improving the quality, safety and reliability of medical tests and to properly regulate new products. These new regulations are the EU Regulation for In Vitro Diagnostic Medical Devices 2017/746 (IVDR). The new IVDR will also address the concerns of clinicians and scientists over the quality control of products, the quality of information provided by self-test manufacturers for certification, and the traceability of products from manufacturer to retailer.
The UK regulations for all medical tests, including self-test kits, have been similarly updated to the 'Medical Devices Regulations 2002 (SI 2002 No 618, as amended)', to reflect the need for more stringent regulations and controls, and will mirror the requirements of the European IVDR.
These changes will have a significant impact on self-test diagnostics ranged by pharmacies and multiple retailers.
The new IVDR, and their UK equivalent, are heavily focussed on patient safety, and require substantially more evidence from manufactures of all medical diagnostics, including self-test kits, on their accuracy, stability, reliability, manufacturing methods and quality control. The cost to many manufacturers of recertifying every test to the new regulations is likely to be prohibitive.
These enhanced regulatory requirements will have a significant financial and operational impact on the medical device industry, to the extent that some low cost/low margin manufacturers may decide to withdraw some self-test ranges from UK and EU markets, as their CE certificates become close to expiry, instead focussing on countries where a less burdensome regulatory environment exists.
These regulatory changes have not been without warning, but the demands on the Notified Bodies that are responsible for ensuring manufacturers meet the new regulations, far exceeds their current resources. Only those manufacturers that have already been proactive, and actively engaged with the Notified Bodies to implement the transition, stand any chance of meeting the deadline for the certification of their products to IVDR. Following the deadline, (May 2025, or the expiry of their CE certificate, whichever is sooner) any products without certification under IVDR will no longer be able to be placed on the market.
SELFCHECK - high quality diagnostics and professional customer care
SELFCHECK has been a leading British brand of self-test screening tests for over 10 years, where high quality products, and professional customer care, is integral to the brand identity. The range currently has 16 health-checks that give results at home in minutes, retailing from £7 to £20, including tests for coeliac disease (gluten sensitivity), bowel cancer screening (FIT), syphilis, chlamydia, prostate health (PSA), and cholesterol. Further tests are in development for launch Q4 2023, Q1 2024.
Retailers of SELFCHECK have peace-of-mind knowing that the key medical components used in our test kits are sourced from UK and EU medical device companies that already have IVDR certification, or are proactively engaged in implementing the transition process of IVDD to IVDR with their Notified Bodies. The test kits themselves are assembled at our own ISO13485 certified facility in North Wales, demonstrating our continued investment and commitment to reliability, patient safety, and continuity of supply for our pharmacy and multiple retailer customers.
For further information please contact our Quality Assurance & Regulatory Manager.