Anaesthesia machine

The facts - medical devices

There have been very few counterfeit medicines or medical devices identified in the UK. However, it is important to continue to be vigilant as trade in counterfeit medicines is expected to increase around the world.

  • The term 'medical device' covers all products, except medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability. The range of products is very wide: it includes contact lenses and condoms; heart valves and hospital beds; resuscitators and radiotherapy machines; surgical instruments and syringes; wheelchairs and walking frames.
  • Counterfeiters concentrate on low cost, high turnover, high demand products.
  • There are no known cases of counterfeit devices being manufactured in the UK.
  • The UK is an end user market or transit point for the products.
  • Most UK cases have involved the supply of counterfeit devices direct to consumers rather than healthcare professionals, through small retail outlets.
  • Counterfeit medical devices have been seen as commodities used in VAT carousel fraud.
  • Cases in the UK that are known to have reached consumers include condoms, and dental material for use in fillings.
  • Incidents of counterfeits intercepted before reaching consumers include glucose test strips for use in conjunction with Insulin, and corrective contact lenses.
  • Counterfeit devices seized within the UK are usually packaged to a high standard and difficult to distinguish from the genuine article.
  • In the past 12 months there have been ten reported incidents all concerning counterfeit condoms.
  • Counterfeit devices are also supplied through Internet websites.
  • Unlike medicines, wholesalers do not require a licence to trade in medical devices.
  • Counterfeit medical devices are dangerous, they are deficient in terms of quality and performance.

How can counterfeit medical devices be avoided by the public?

Some people will always break the law.  Our objective here is to make sure that we have robust systems in place to prevent counterfeit medicines penetrating into the UK's pharmaceutical supply chain and if penetration occurs, to have safeguards to detect counterfeits early and protect the public accordingly. Worryingly, a growing number of purchases of medicines and medical devices are now made over the Internet, through online pharmacies, via Internet auction sites, or by mail order.

The source of these products is often very hard to trace and it is highly unlikely that the 'manufacturers' behind these products conform to European standards of safety and effectiveness.  This has led to people being deceived that the medicine or medical device they have bought was the genuine product.

Worse than this is the fact that substandard or counterfeit medicines may have little, none, or too much of the required quantity of the active ingredient - all of these scenarios could present significant risk of harm to the patient.  The main areas of concern related to buying prescription only medicines over the Internet are:

  • the medicine may seriously harm you or a member of your family
  • they may not have been prescribed by a healthcare professional
  • there may not be checks and controls on the quality and effectiveness of medicines supplied
  • there may be no legal or judicial recourse in the event of problem.

Medical devices - Compliance Unit

The Devices Compliance Unit is responsible for enforcement of the Medical Devices Regulations. To do this, we are legally obliged to operate two separate programmes:

  • A pro-active programme where manufacturers are chosen by us for investigation; and
  • A re-active programme where we investigate possible breaches of the Regulations reported to us by various third parties.

Where non-compliances are identified we, will work with the manufacturer to resolve the problem. However, where necessary and justified we have the powers detailed below to take formal enforcement action against an manufacturers (subject to fulfilling various EU obligations).

The Medical Devices Compliance Unit has responsibility for implementing and enforcing the Medical Devices Regulations in an effective and efficient way taking appropriate and proportionate action where necessary to correct any breaches identified. In particular:

  1. Complete reviews of a programme of manufacturers and products selected by the Agency for inspection; and
  2. Complete investigations into suspected breaches to the Regulations reported to us by third parties.

Consider, make proposals for, and implement a joint enforcement programme with one or more of our EU partners with a view to developing effective inter-state co-operation in the field of enforcement.

The Medical Devices Regulations are made under the Consumer Protection Act 1987 and the majority of the powers that can be used in carrying out the enforcement function are also derived from the Act. These include the power to inspect goods, enter premises, require records to be produced, seize and detain goods in order to find out if there has been a contravention of the safety regulations. Then if a contravention is found to issue notices suspending or prohibiting the supply of the product or as mentioned above if the manufacturer fails to bring the product into compliance voluntarily or adhere to formal enforcement measures to prosecute the offence. We also have additional powers for consumer products available direct to the public under the General Product Safety Regulations which include the power to require a manufacturer to recall faulty product. A successful prosecution under the Medical devices Regulations carries a maximum penalty of a £5,000 fine per offence or six months imprisonment and under the General Product Safety Regulations of a fine of £10,000 per offence or 12 months imprisonment.

Another role of the MHRA is to provide advice to the public on the safest ways to purchase medicines and medical devices, for example by buying prescription only medicines over the Internet only when you have a prescription and to use a reputable e-pharmacy which is registered with the Royal Pharmaceutical Society of Great Britain (RPSGB) and can be checked at www.rpsgb.org/registrationandsupport/registration/searchourregisters (external link); or by ensuring that devices come from a reliable source, are well-maintained, come with instructions and carry a valid CE mark.

 


Page last modified: 02 May 2012