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Medical Device Classification

A medical device is a device and a pharmaceutical is a medicinal product surely that is clear?  Obviously a syringe is a device and what it contains that is injected is a medicinal product!  Well?  Not always!  It can depend on how the injected product works.  The European Medical Devices Directive definition is:

‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
  • investigation, replacement or modification of the anatomy or of a physiological process,
  • control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

The first point then is – how does the product work?  The substance in the syringe may be a joint lubricant and the action is neither pharmacological, immunological nor metabolic and so it is a device – syringe and contents.   

Other materials that might not seem to be ‘devices’ at first glance include:

  • bone cements,
  • dental filling materials,
  • materials for sealing, approximation, or adhesion of tissues (e.g. cyanoacrylates, fibrin-based adhesives not of human origin)
  • sutures including absorbable sutures

whereas another which would appear to be a ‘device’ – an intaruterine contraceptice device – is not (its principal means of action is to release progestrogens and its action is therefore metabolic).

The classification – device or medicine – may depend on the manufacturer’s claims of how the product works or its application.  A medicated bandage can be a device or a medicine.  Eyedrops are a device if unmedicated or a medicine if medicated.  Even if it is a device, the classification class may vary depending on its intended use - cotton wool can be a Class I device (that is one with least risk and the simplest regulatory pathway) if used as a 'mechanical barrier' but the tougher regulatory regime for a Class IIb device if intended to be used principally with wounds which have breached the dermis.   

What difference does this make?  A medicine tends to take longer to get to market than a device and in Europe, each country has to grant marketing approval for a medicine but in general, once a device is approved in one Member State the manufacturer only has to inform the other States that the product is being placed on the market which is quicker and cheaper.  A Class I device has a less restricted regulatory pathway than a Class IIb and the need to engage with a 'Notified Body'. 

With such border line cases, interaction with the regulators is essential.  The regulators are generally helpful and co-operative but they have their rules - which can differ from country to country - and a clear and logical strategy to present the manufacturer’s case may be necessary.  And the 'manufacturer' is not necessarily the organisation that makes the product - it is whoever places the product on the market, and that is not just selling.