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The Medical Devices Regulation: An update

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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Upcoming Events

Central Sterilising Club - Annual Scientific Meeting 2024

Crowne Plaza at Gerrard’s Cross
15th April 2024 – 16th April 2024

DECON UK 2024

National Conference Centre, Birmingham
17th April 2024

Infection Prevention & Control

National Conference Centre, Birmingham
23rd - 24th April 2024

Theatres & Decontamination Conference 2024

Coventry Building Society Arena
16th May 2024

The AfPP Roadshow - Birmingham

Millennium Point, Birmingham
18th May 2024

The AfPP Roadshow - Exeter

University of Exeter
22nd June 2024

Access the latest issue of Clinical Services Journal on your mobile device together with an archive of back issues.

Download the FREE Clinical Services Journal app from your device's App store

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