Changes are coming to the way in which the Medicines & Healthcare products Regulatory Agency (MHRA) ensures the safety and quality of medical devices.

A series of improvements are being made to modernise the current system that will ensure better protection of public health and patient safety. The new Regulation for Medical Devices (MDR) which entered into force on 25th May 2017 is a balancing act of proportionate responsibility and an increasingly technological approach to healthcare.

PMG members may be interested in MHRA’s introductory interactive guide to the new regulations, which is available to read here.

For the first time, the new regulation introduces requirements for the manufacture and use of devices within the same health institution that will allow them to be exempt from the full conformity assessment that would otherwise be required if they were to be placed on the market. This so called health institution exemption (HIE) will become mandatory on 26 May 2020.

The previous directive had no regulatory requirements for in-house manufactured and used devices.

MHRA have issued draft guidance for consultation on the HIE; the consultation ran from 22 January 2018 to 31 March 2019. It is expected that the guidance will be finalised by the end of summer 2019.

If an item (including software) is being considered for manufacture and use in-house, and meets the definition of a medical device, and falls into one of the categories considered as manufacture, then Article 5.5 of the MDR has to be applied.

The definitions of a medical device and an accessory for a medical device, the activities considered as manufacture, and Article 5.5 are set out here.

PMG wishes to acknowledge the additional detail provided above by Justin McCarthy of Clin Eng Consulting Ltd, Cardiff