On 5 April 2017 the European Parliament approved new EU rules on medical devices, concluding the EU process of negotiations on these new EU laws, originally proposed by the European Commission in 2012.
The final texts of the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation were published in the Official Journal of the European Union on 5 May. Member States have until 26 May 2020 to apply the Medical Devices Regulation and until 26 May 2022 to apply the In Vitro Diagnostic Medical Devices Regulation.
Advice for NHS organisations
Although this legislation is principally targeted at manufacturers of medical devices who wish to place their products on the EU single market, there are a number of requirements for health institutions, either as end users of these products, or as organisations that modify, manufacture and use medical devices and IVDs for their own patients.
For a full briefing on the key changes for NHS organisations, and how to prepare for the new legislation, please see our joint publication with the Institute of Physics and Engineering in Medicine (IPEM). This briefing includes information on how NHS organisations can interact with the MHRA, as they prepare their guidance and implementation plans.
The European Commission has published its own fact sheet detailing what healthcare professionals and health institutions need to know about the new regulations, available here.
NHS organisations often produce diagnostic tests in-house or modify commercial kits to conduct essential specialised tests for specific groups of patients. They also modify or produce medical devices, such as software for MRI scanners and devices for use on special groups of patients (for example, infants and children). These practices allow the NHS to provide state-of-the-art healthcare to patient groups needing specialised care, to respond rapidly to new or emerging threats, and to promote the development of more innovative solutions through collaboration by medical researchers with peers.
The original proposals for new EU legislation seriously threatened the ability of NHS hospitals to continue to modify or produce diagnostic tests and medical devices ‘in house’. The proposed restrictions could have resulted in negative implications for patients, such as:
- Delays in providing healthcare, with turnaround time for new industry manufactured devices for novel and/or emerging diseases significantly longer than those produced ‘in-house’;
- Lack of available CE marked tests and devices for certain conditions or groups of patients. Test devices for certain rare genetic and infectious diseases are not available on the market, and devices for rare conditions may not be manufactured where no commercial incentive exists; consequently, there could have been implications in terms of the ability to carry out some diagnostic tests for certain patient groups in the future;
- Lack of devices modified to make appropriate and safer for use on certain populations, for instance, for use with infants and children.
The NHS European Office engaged extensively throughout the EU process, informing EU decision-makers of possible consequences of their proposals and suggesting changes in the interest of the NHS. Thanks to our influencing work, EU decision-makers recognised the need to ensure that hospitals can continue to produce devices and diagnostic tests ‘in house’ in the future, while ensuring that their quality and safety is guaranteed by light touch provisions.