Companies wishing to sell to the NHS will need to understand the regulatory requirements appropriate to their technology, product or service.ÿ In today?s competitive and highly regulated healthcare environment, companies need to understand regulatory issues in order to bring new products to the market and subsequently keep them on the market. Excellence in managing regulatory issues is therefore a key strategic advantage to healthcare companies.
In the UK, like all member states of the European Union, medical devices are regulated by specific directives designed to provide clear explanations around what is defined as a medical device.ÿ For a company to legally place a medical device on the EU market, the conditions of these directives must be met.ÿ Once met, a CE mark can then be applied by the manufacturer of the device.
Devices that fall within the scope of the directives are categorised into classes according to the degree of risk inherent in the device.ÿ Due to the wide range of medical devices covered, these device classifications exist to enable technologies to be subjected to an appropriate level of conformity assessment determined by their perceived level of risk.ÿ This risk based system is in place to ensure that low level risk products are not subjected to the same levels of scrutiny and assessment as those in the high risk categories thereby ensuring that companies are not inappropriately overburdened during the assessment process.
It is the stated intended purpose of the device, assigned by the manufacturer, which determines the class in which a device is categorised.
?General? medical devices are classified as follows:
- Class I – generally regarded as low risk
- Class IIa – generally regarded as medium risk
- Class IIb – generally regarded as medium risk
- Class III – generally regarded as high risk
In the UK, the MHRA (Medicines and Healthcare Products Regulatory Agency) is responsible for regulating all medicines and medical devices, ensuring they work and are acceptably safe, acting as the UK ‘Competent Authority’ and regulator for the medical device industry.ÿ The MHRA works closely with the European Regulator, the European Medicines Agency (EMEA), and is recognised as a trusted and independent source of expertise throughout Europe. The agency collaborates with other international regulators, such as the US Food and Drug Administration (FDA), and UK government healthcare agencies including the National Institute for Health and Clinical Excellence (NICE).ÿ The processes for licensing and authorising medicines and devices differ but rigorous standards are applied by the MHRA throughout to ensure that medicines and devices work and are acceptably safe.
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Medilink North West
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Event: Joint EFGCP-MedTech Europe conference, London, June 2015
BSI publishes a code of practice for health and wellness apps
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