|Theme||Compliance with MD Regulation|
Regulation (EU) 2017/745
This position paper of the MDCG gives a numerical overview of the state of play regarding applications for conformity assessment under the Regulation and reminds that the transitional provisions of the Regulation should not be considered as a “grace period” to postpone the application of the new rules.
It specifies that derogation from the conformity assessment procedure in accordance with Article 59 of the Regulation may only be granted if the use of the device concerned is in the interest of public health. This derogation cannot be considered as a solution for cases of late application to a notified body for conformity assessment or delays in the conformity assessment procedure.
In order to ensure that devices can continue to be placed on the market and to avoid shortages of MDRs, it is essential that all manufacturers adjust their system, finalise the transition to the MDR and apply to a Notified Body, submitting complete and compliant applications, as soon as possible and well before the end of the transitional arrangements (at least 1 year before expiry date certificate).