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Regulatory Requirements

Companies wishing to sell to the NHS will need to understand the regulatory requirements appropriate to their technology, product or service.  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.  For a company to legally place a medical device on the EU market, the conditions of these directives must be met.  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.  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.  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.  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).  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.

מוציא לאור של הנכס מוציא לאור של הנכס

Kershaw Technology Services

Kershaw Technology Services is a consultancy based in Cheshire, with clients across the UK, specializing in regulatory compliance for Medical devices particularly in product development. ...

Lucid Innovation

Lucid Innovation is a professional industrial design and creative engineering team that has helped organisations develop their competitiveness with innovative, sustainable product ideas, design,...

MAE Consulting Group

MAE Consulting Group specialises in regulatory affairs, clinicial affairs, project management and compliance services support to SMEs with a focus on the medtech and in vitro diagnostics sectors....

Medilink North West

Medilink North West is a membership-based professional organisation with a remit to stimulate growth and innovation in the medical and health technology sector throughout the North West. It...

ORCHA

ORHCA are the Organisation for the Review of Care and Health Applications. Their mission is to help the public and health care professionals meet their health and wellbeing targets...

TRUSTECH

TRUSTECH is an NHS organisation that aims to improve healthcare through the development of innovative products and services. TRUSTECH works with NHS organisations, companies and regional,...

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Event: Joint EFGCP-MedTech Europe conference, London, June 2015

This Joint EFGCP-MedTech Europe conference will explore existing best practices and forthcoming changes in the clinical development of medical devices. Through dialogue between regulators,...

BSI publishes a code of practice for health and wellness apps

BSI has published a code of practice which defines a set of quality criteria for the development, testing and releasing of health and wellness apps.

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Are you interested in working with the GM AHSN to provide support to businesses working in the healthcare sector? Would you like to be listed as an Associate on the Innovation Nexus portal? Contact us to discuss how we could work together.

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