As of 1 September, all medical devices must again have a CE marking
Updated 10 December
As of 1 September 2020, all medical devices used by care providers must have a CE marking. Since mid-March, due to shortages caused by the corona pandemic, the Dutch Health and Youth Care Inspectorate (IGJ) has temporarily allowed the use of alternative medical devices without a CE marking in case of emergencies. As of 1 September, that will no longer be the case. For the time being, an exception will be made for surgical face masks, gloves, and requisites for corona tests.
As of September, manufacturers and suppliers will also not be permitted to deliver medical devices without a CE marking. A CE marking guarantees that their product complies with the legal requirements.
Exceptions
An exception still applies for surgical face masks, gloves, and requisites for corona tests. For these items, the same conditions and flexibility will continue to apply as was announced in March. This exception is of a temporary nature. An announcement will be made at a later date as to when these products will again be permitted only if a CE marking has been provided.
Use is no longer permitted, but may be stored
With the exception of facemasks, gloves, and test materials, care providers may no longer use medical devices that do not have a CE marking as of 1 September. However, they are permitted to keep their stock in storage, in case shortages unexpectedly arise once again in the event of a possible second surge of the corona virus.
Customisation remains possible
As of 1 September, deviations from the Medical Devices Act (WMH) will no longer be permitted, with the exception of facemasks, gloves, and test materials. However, this legislation does allow for customisation. In specific cases (emergency situations), an exemption can be granted for the delivery and use of alternative products. In such cases, a care provider can contact the Inspectorate. The Inspectorate will then assess whether such an exemption is necessary.
Personal protective equipment
Personal protective equipment, such as FFPx face masks as well as a large number of aprons, coats, and face shields are subject to the supervision of the Social Affairs and Employment Inspectorate (Inspectie SZW) when used professionally. For more information, we refer you to: https://www.inspectieszw.nl/onderwerpen/algemeen-productveiligheid-en-certificatie.