Coronavirus: More flexibility for manufacturers and suppliers in case of shortages of medical devices
As a result of the coronavirus outbreak, there may be shortages of medical devices that are critical for delivery of professional health. The Health and Youth Care Inspectorate will temporarily allow manufacturers and suppliers to supply medical devices that do not carry a CE marking or that have not gone through the conformity assessment procedure. However, this is subject to the following conditions: the healthcare provider must explicitly request the alternative medical equipment and are also responsible for their use. There must also be no approved alternatives available.
Addition 11 August 2020
When supplying alternative medical devices with a relatively low risk profile (products in class I), the manufacturers and suppliers do not have to notify the IGJ accordingly. When supplying alternative medical equipment with a higher risk profile (class IIa/b and III), the IGJ must be notified beforehand. An instruction is contained in the appendix.
An exception to this procedure is applicable for medical devices (like ventilators) and in-vitro diagnostics (tests) which are purchased via a central national working group initiated by the Ministry of VWS. Manufacturers and suppliers are requested to send specifications and information about the fulfilment of technical and clinical requirements to email@example.com. The inspection will forward the information to the relevant working group.
Healthcare provider remains responsible
Of course, in case of shortages, the healthcare provider remains responsible, personally or within the framework of the professional group concerned, to strike a carefully considered and responsible balance between the risks and benefits. On the one hand, there are risks associated with the use of alternative equipment and, on the other hand, there is the responsibility to provide care. The Inspectorate already pointed this out to care providers earlier.
Medical devices with a CE marking complies with the regulations for the design, the manufacture, and the marketing of the devices for the intended use. This has not been assessed for products without a CE marking or for a different use other than the intended one. In case of critical shortages, the healthcare providers will have to take this into account in their considerations.
Registering the considerations
In the current complex situation, the IGJ considers it important for healthcare providers, manufacturers, and suppliers to have the flexibility to organise the care system as optimally as possible. However, in order to be able to account for their actions retroactively, they have to register their considerations and decisions in a traceable manner.
Role of the IGJ
The IGJ monitors compliance with laws and regulations in the area of healthcare, including the Healthcare Quality, Complaints and Disputes Act (Wkkgz). The Wkkgz is based on the principle that healthcare providers are responsible for providing good care. In addition, the IGJ assesses the working procedures and methods of care providers with the help of field standards and guidelines. The professional groups concerned have drafted these themselves.