Medical device regulations

Medical device regulations require manufacturers to ensure their devices are safe and fit for purpose before being placed on the market. The regulations vary from country to country.

For example, in the UK, medical devices are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). In the USA, medical devices are regulated by the Food & Drug Administration (FDA).

Counterfeit equipment: What can be done?

Unfortunately, many developing countries lack robust regulatory systems for medical devices. Some do not have an agency to regulate either medical devices or the companies that sell them.

This means that unregulated vendors can easily sell equipment that doesn’t conform to international quality or safety standards and that may be counterfeit.

There are a couple of things you can do to check whether the equipment is genuine or counterfeit:

• The country may have a national list of recommended medical equipment or minimum specifications.
• If this is not available, the Ministry of Health may have a list of pre-approved suppliers and devices.
• If there are no national regulations in the country where you are donating the equipment, you should abide by UK/EU or your home country’s standards.

CE marks

Within the EU, the CE mark is a symbol placed on a medical device that declares it is compliant with EU regulations – and enables the device to be sold in the European Economic Area.

There can be confusion about supporting documentation. We will cover recent issues about counterfeit PPE later in the course, but in summary:

• The CE mark should be on the medical device or product.
• The supplier should also be able to provide a CE certificate and Declaration of Conformity – which are types of supporting documentation, but not a substitute for the CE mark being on the product itself.

Bear in mind, the CE mark (or equivalent) can be counterfeited, so don’t take this as an absolute guarantee without doing extra research.

Want to know more?

The British Safety Industry Federation have produced a useful detailed guide on how to check if a CE certificate or Declaration of Conformity is counterfeit, illegal or incorrect.