Alert Issued On Counterfeit Or Non-CE Dental Medical Devices

Risk Of Failure Could Lead To Injury, According To MHRA


A medical device alert has been issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) regarding concerns related to counterfeit or non-CE marked dental medical products purchased online.

The regulatory body has urged dental professionals to ensure that any such devices are always bought from a legitimate manufacturer or supplier, as well as to ensure all devices also include the relevant CE market.

Any suspect counterfeit devices should also be reported to the MHRA, with concerns being raised that such products could fail during use and pose a risk of injury to patients.

The MHRA added that the British Dental Association has a list of companies that manufacture or supply legitimate products.

Expert Opinion
This kind of notice is a timely reminder to the dental and medical profession of the important role that the European Union’s current regulatory regime plays. While there is scope for improvement to provide better protection to patients, it still needs to be carefully monitored to reduce risks to patients’ safety.

"Counterfeit and non-CE marked devices can pose significant risks to patients and it is vital that professionals completely understand and recognise this in their work. The safety of patients must always come first.

"National and European legislation has been put in place to protect patients and consumers from dangerous products. When something does go wrong the law enables patients to seek redress from the manufacturer of a faulty product directly.

"Legitimate manufacturers will have insurance to ensure that they can compensate consumers and patients following damage having been caused by their products. However, counterfeit companies are unlikely to have the means, insurance or intent to protect the interests of consumers and patients and for this reason it is vital that medical professionals remain vigilant that the products they provide to their patients are safe for use and from legitimate sources."
Kevin Timms, Solicitor