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Product regulation

Steve Lee from the Association of British HealthTech Industries looks at the potential impact on medical laboratory services.

Ensuring the safety and performance of products used in testing services is changing significantly and will continue to change over the next two
to three years. These changes are already beginning to affect the availability of some products in the UK.

Many of the products used in medical laboratory testing services meet the definition of an in vitro diagnostic medical device (IVD) (see What are IVDs?) and are, therefore, subject to regulation of their safety and performance. Regulation is primarily concerned with enabling patient access to high-quality, safe and effective IVDs, and avoiding access to products that are unsafe. When appropriately implemented, regulation ensures public health benefit and the safety of patients, healthcare workers and others.

Until now, most IVDs have had a relatively low level of regulation with little independent scrutiny of products prior to them being placed on the market. The exceptions include products used to ensure the safety of the nation’s blood supply. However, as the COVID-19 pandemic has highlighted, demonstrating the safety and performance of IVDs can sometimes be inconsistent and users often independently validate performance.

What are IVDs?

IVDs and their accessories can be intended for screening, monitoring, diagnosis, aids to diagnosis, prognosis, prediction or as a companion diagnostic for a medicinal product. IVDs can include reagents, calibrators, control materials, equipment, software and specimen receptacles intended to provide information on physiological or pathological states, congenital impairments, predisposition to medical conditions, predicted treatment response or compatibility with potential recipients.

New regulations are intended to improve product safety and performance requirements with additional scrutiny before a product can be placed on the market. This should provide greater reassurance that products will perform as the manufacturer intends and should reduce the amount of user validation needed prior to commissioning a new product.

However, not all existing products will be able to meet these new requirements and will either need to adapt to the new regulations or be removed from the market. For some manufacturers, the cost of meeting the new requirements may mean that they will no longer be able to supply them.

There are two major milestones to consider. The first milestone concerns the EU “CE mark”, which will be accepted in the UK up until June 2023. The second milestone is the UK’s own sovereign regulation for the “UKCA mark”, which will be mandatory from July 2023.

New EU regulations

The first regulatory change to apply is the EU regulation on IVDs. IVDs placed on the market in the EU need to renew their CE mark to fit the new requirements. May 2022 marks the end of a five-year transition across to the new regulations and many manufacturers will be able to offer a seamless transition without any noticeable effect on availability.

However, there are concerns that some manufacturers may not be ready for the new regulations because their attention has been focused elsewhere – not least in providing IVDs essential to tackling the pandemic. There are also significant concerns about the readiness of the EU infrastructure for assessing products for the new CE mark. For some products, manufacturers will decide that some, or all, of their products cannot meet the new requirements in an economically viable way, so will voluntarily remove these products from the market.

There are also significant changes to the exemption for IVDs that are made and used within a single EU or Northern Irish health institution, which means that not every EU or NI health institution will be able to continue using the exemption.

This means that some IVDs and some testing services will not be available to you either temporarily or permanently. There have been calls for a relaxation to give more time for the EU system to be ready for manufacturers
and health institutions. The European Commission has recently responded with proposals for new dates that have yet to be ratified in the European Parliament. It remains to be seen if the proposed new dates will go far enough.

New UK regulations

Until June 2023 it will be possible for manufacturers to use either the CE mark, based on EU regulations, or the new UKCA mark, based on UK regulations. From June 2023, it will only be possible to use the UKCA mark for products placed on the market in Great Britain. (Northern Ireland will continue to allow products with a CE mark.) The regulations that underpin the UKCA mark for IVDs will be changing too and we expect the transition for these regulations to end in June 2023. We do not yet know what these regulations will be, but we expect them to have similarities with the EU regulations for IVDs. Although we do not yet know what the regulations will be, it is possible that not all IVDs on the UK market will be able to meet them. This means that some IVDs and some testing services will not be available to you either temporarily or permanently.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a public consultation on the new UK regulations for IVDs. The consultation ( closes on 25 November. Although the consultation looks daunting at first, it’s possible to jump straight to chapter 17 and use a simplified version. This is a generational opportunity to influence how the medical products that you use should be regulated for safety, quality and performance.   

How to stay informed     

  • Ask your supplier if they are prepared  for the IVDR or are planning on removing some IVDs from their catalogue.   
  •  Will you need to fully validate new tests prior to commissioning, or can you simply verify performance? Will this affect your UKAS accreditation?   
  •  If you rely on the exemption for in-house manufacturing can the new exemption continue to apply? Do you know what the new exemption requires?     
  • Will you be able to contribute to the UK consultation? Will you contribute via your trust or your professional body (or both)? The MHRA website for devices regulation and registering for updates may be useful to help you stay informed.
  • If your testing service may be affected negatively, do you have a plan B?

Steve Lee is Director of Diagnostics Regulation at the Association of British HealthTech Industries. He previously worked at the MHRA and trained as a biomedical scientist.

Image Credit | Shutterstock

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