Following the publication by the European Commission of a correction to the 13 May 2016 list of harmonized standards under the European Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic (IVD) medical devices, the NHSBSA and Department of Health have sought clarification from the Medicine and Healthcare Regulatory Agency (MHRA).
The MHRA has confirmed that manufacturers can choose to use the international harmonised standards to demonstrate compliance of their product(s) to the requirements of the applicable medical device directive but that this is not mandatory. Provided the Notified Body is satisfied with the safety and performance of the blood glucose reagent strips and the manufacturer holds a current CE certificate issued by a Notified Body designated to the IVD directive, the Department of Health and NHSBSA consider that the criterion of being ‘safe and of good quality’ for listing in Part IXR of the Drug Tariff has been satisfied.
In summary, there will be no de-listing of any blood glucose reagent strips listed in Part IXR of the NHS England and Wales Drug Tariff unless the manufacturer notifies the NHSBSA that they do not hold a current CE certificate issued by a Notified Body designated to the IVD directive.