Manufacturers urged to action on MDR implementation

EU issues notice to manufacturers to ensure timely compliance with MDR requirements

The transitional arrangements for the Regulations allow for medical devices and in vitro diagnostic medical devices with valid certificates or declarations of conformity to the Directives to continue to be placed on the market for finite periods. While the Medical Devices Regulation (MDR) has been applicable since 26 May 2021, these transitional provisions allow medical devices certified under the Directives to be placed on the market until the expiry date of relevant certificates and no later than 26 May 2024. Currently, 30 Notified Bodies are designated under the MDR and these manage approximately 80% of current certificates.

Notified bodies provided data to the EU in April 2022 showing that:

• More than 90% of currently valid certificates for medical devices will expire in 2023-2024
• Around 70% of certificates will expire in the first five months of 2024
• By December 2021, nearly 37% of manufacturer's MDR applications were refused because incomplete, while in April 2022, the percentage has increased to 50% out of 75% of Notified Bodies submission rate.

The Medical Device Coordination Group (MDCG) is composed of representatives of Member States and chaired by the EU Commission. The MDCG has endorsed a position paper - MDCG 2022-11 -giving notice to manufacturers to ensure timely compliance with MDR requirements.

The MDCG position paper states that:

• The MDR will be fully applicable to all medical devices from 27 May 2024
• Manufacturers are responsible to ensure that their devices comply with the MDR from the end of the transition
• Notified Bodies designated under the MDR might not have capacity to assess the documentation for all devices with certificates expiring in the first months of 2024
• Medical devices not certified under the MDR from 27 May 2024 will have no access to the EU market

It should be considered that Article 59 of the MDR provides a mechanism for derogation from the Conformity Assessment Procedure. This process has been mentioned as potential solution if transition from the Directives to the MDR is not completed in time. However, derogations can be granted by competent authorities only if the use of the device concerned is in the interest of public health, patient safety or patient health. Therefore, derogations should not be considered as a means to solve late applications to a Notified Body for Conformity Assessment Procedure. The position paper concludes that it is essential that all manufacturers finalise transition to the MDR and apply to a Notified Body with complete and compliant applications as soon as possible and well in advance of the end of the transition period. 

Manufacturers should note the position of the MDCG and take the opportunity to review the progress of their transition plans. They should consider the capacity of their Notified Body to assess devices with certificates expiring at the end of the transition timeline.