Medical devices

Medical devices

The life sciences sector encompasses companies in the fields of pharmaceuticals, biotechnology and medical technology that focus on the research, development and commercialisation of a wide range of products that have a medical application. Such products include pharmaceuticals (ie everything from over-the-counter painkillers to advanced therapies for treating diseases such as cancer or HIV), medical devices (eg plasters, syringes, heart stents, pacemakers, etc) and diagnostics.

Understandably, the life sciences sector is highly regulated and the development and commercialisation of products in the life sciences sector is subject to stringent rules. However, there is not one clearly defined body of ‘pharmaceutical’ or ‘life sciences’ law, instead, a complex framework of rules exists that derives from a variety of sources. In the EU, a large amount of the regulation originates from Directives or Regulations and is supplemented by guidance issued by the European Commission and by the European Medicines Agency (EMA), the decentralised agency of the EU responsible for the scientific evaluation, supervision and safety monitoring of medicines.

Article 2(1) of Regulation (EU) 2017/745, the Medical Devices Regulation (MDR) defines a medical device as ‘…any instrument, apparatus, appliance, software,

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