The Medical Devices Regulation, which replaces the Medical Devices Directive, is in a transition period, during which the MDD remains valid until 25 May 2020. After this point the MDR is to be fully applied. Justin McCarthy, CEng, FIET , FIPEM, consultant clinical engineer, examines the implications for in-house development of medical devices and software.
Although the basic principles of the MDR are consistent with the MDD, there are substantially increased requirements for designers, manufacturers and importers, and for anyone within a health institution who develops a device for use only within that institution. ‘Health institution’ means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health. Software that has a specific medical purpose is likely to be a medical device.
The definition is in Article 2(1) and the most relevant parts in this context are given below.
The MDD was completely silent on the issue of medical devices manufactured and used solely within a health institution, ie: not ‘placed on the market’. In the UK, based on a careful reading of the definition of ‘put into service’, (the other criteria requiring CE marking) the advice from MHRA was that with certain provisos, such devices did not require CE marking and so were not covered by the MDD nor by the UK regulations giving them force in the UK. (MHRA, 2014)
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