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European Pharmaceutical Contractor
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A single set of European regulations for medical devices was gradually introduced during the 1990s, which standardised the requirements that companies must meet before placing their products on the European Community (EC) market. The medical device regulations are part of a regulatory framework known as the 'new approach', which is essentially a means to remove technical trade barriers between EU member states while protecting the health and safety of its citizens, and stands in contrast to the regulations governing medicines. Unlike medicines, the balance of regulation and requirements that must be met prior to the marketing of products is heavily weighted towards the principles of good manufacturing and design, with rather less emphasis on a lengthy multi-phase clinical development process. This difference in the development process between medicines and devices and the fact that the lifecycle of a medical device can be relatively short - with some companies producing improvements and iterations of currently marketed products several times a year - are important when considering the approach to bringing medical devices to the European market.
What is a medical device? The definition of what characterises a medical device may seem academic, but in fact it is an essential classification that underpins the specific route which medical technology manufacturers must take in order to bring their particular products to market.
For the purposes of the European directives, a medical device is any medical technology to be used on humans that does not achieve its main purpose by pharmacological, immunological or metabolic means, but may be assisted by such means. The main intention of such a definition is to ensure that devices and medicinal products can be distinguished and that regulation is based on the appropriate set of directives, although other directives may be applied accordingly.
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By David Wright, Managing Director/ Director of Clinical and Regulatory Affairs, and Richard Wyse, Medical Director, at Celsus Ltd
David Wright is Managing Director/Clinical & Regulatory Affairs Director for Celsus Ltd., a CRO for medical devices. He has 10 years of experience in the medical device industry. After gaining a BSc in Software Engineering at the University of New South Wales, Sydney, he worked for Telectronics Pacing Systems, an implantable pacemaker manufacturer in R&D. Following this he managed Telectronics' European clinical trials for new products and European centres involved in US Investigational Device Exemption trials. He later joined St Jude Medical as a Clinical Project Leader and was responsible for running multinational clinical trials for new products to support regulatory approvals both in Europe and the US. He is a Founding Member of the medical device sub-committee at the Institute of Clinical Research, the industry body representing clinical research professionals in Europe. He is currently completing an MSc in Clinical Research from Cardiff University, UK.
Dr Richard Wyse is Medical Director at Celsus Ltd. Previously he was a Senior Lecturer in Paediatric Cardiology at the University of London. After gaining an MBA at Imperial College, UK, he was appointed Medical Director, then later, Managing Director (Europe) of a US-based corporation providing R&D consultancy services and customised software for pharmaceutical companies. He has consulted for a large number of health technology companies across several therapeutic areas. These include developing health economic, patient outcomes and disease management programmes, designing and undertaking health economic studies to help gain market access, and facilitating the appropriate outsourcing of industry-led cost-effectiveness projects. Currently, as Worldwide Chairman of a surgical consortium, he helps manage a major joint European, US and Asian project to establish a cardiac and thoracic surgical patient registry involving more than 2,700 hospitals worldwide.
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Small Scale Biomanufacturing – clinical trials, cell & gene therapies
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