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Legal view: The difference between lawful and unlawful COVID-19 tests

“The difference between lawful and unlawful testing kits depends on two letters: CE”

CE marking regulations separate legal COVID-19 test sales from illegal ones, says lawyer David Reissner

The COVID-19 pandemic has thrown up numerous legal and ethical issues surrounding sales of various items. Face masks, hydroxychloroquine, hand-sanitiser and paracetamol have all been in the news. A pharmacist has even been arrested on suspicion of illegally selling COVID-19 testing kits.

The Medical Devices Regulations 2002 define a medical device as – among other things – an appliance intended by the manufacturer to be used for the purpose of “diagnosis, prevention, monitoring, treatment or alleviation of disease”. COVID-19 testing kits clearly come within that definition. But the difference between lawful and unlawful testing kits depends on two letters: CE.

CE stands for Conformité Européenne, a reminder that much of UK pharmacy law originates in the EU. The Medical Devices Regulations 2002 implements the requirements of an EU council directive from 1993 that has two main purposes: firstly to ensure the free movement of goods, and secondly to provide patients and users with a high level of protection in terms of performance.

The regulations work by prohibiting putting on the market or selling a medical device that does not have a CE marking. To obtain a CE marking, the manufacturer must apply to any ‘notified body’ – each member state has one. The notified body is responsible for undertaking full quality assurance including conducting tests of every product and unannounced audits.

The system is not perfect: three years after the 2010 breast implant scandal, a UK government review said that some countries had less stringent CE-marking processes than others, or that it was possible to escape proper inspection.

Currently, there are two ways of testing at home for COVID-19 for both antibody and swab tests. The first requires the sample taken at home to be sent to a licensed lab for analysis. These are lawful if they have a genuine CE marking.

There are also other kits that enable a patient to see the results at home. A CE marking has not yet been given to any test that enables patients to diagnose themselves at home, so it should be easy to spot whether a home-testing kit is legal or not. 

David Reissner is chair of the Pharmacy Law and Ethics Association

Read C+D’s feature on what pharmacists need to know about COVID-19 testing regulation

1 Comments

Dave Rushton @ Paradigm Shift,

Hi David, great and helpful blog. Just a gentle reminder to people that where there is money there are OCGs (Organised Crime Groups), scammers, and falsified or counterfeit products. Please do your due diligence, do not buy from "randoms." We have seen people buying PPE from IT companies, and other firms, and failing to do suitable checks. Also because there is a CE mark, remember it might not be genuine. Whether you are doing this for the right reasons, or money grabbers, you risk prosecution if you do not ensure what you buy and supply is not legal.

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