GFI Extends MDR Compliance for Legacy Devices until 2028

MDR Transition Period Extension: FarmaImpresa Ensures Compliance for its Legacy Devices until 2028

The MDR (Medical Device Regulation), which came into force in May 2017 and has been applicable since May 2021, aims to create a robust and transparent regulatory framework for medical devices in Europe, ensuring safety and promoting innovation.

However, because of concerns about potential shortages of essential medical devices, the transition period extension was discussed in November 2022 to allow greater compliance by manufacturers.

Consequently, it is established that devices that continue to comply with the AIMDD or the MDD can be placed on the market or put into service until:

• December 31, 2027, for Class III devices and Class IIb implantable devices.
• December 31, 2028, for other Class IIb, IIa, and I devices.

This means that a European manufacturer can continue to place new batches on the market until the dates indicated above.

This extension is subject to compliance with specific requirements, including the absence of unacceptable health risks, no significant changes in the design or intended use, the adequacy of the quality management system, and the submission of the conformity assessment application before May 26, 2024.

It should be noted that the sell-off period for devices already placed on the market has been canceled, preventing the disposal of safe devices. Consequently, all medical devices can continue to be sold even after January 1, 2029, until their natural expiration.

Furthermore, the tolerance period for the submission of conformity assessment applications has been set until May 26, 2024, to extend the validity of the MDD certificate, according to the dates indicated above.

Manufacturers can demonstrate compliance with the conditions for the extension through:

• A self-declaration certifies compliance with the conditions for the extension, indicating the end date of the transitional period for their product.
• and
• A “confirmation letter” issued by the notified body that issued the certificate, certifying the receipt of the application and the conclusion of a written agreement between the two parties.

This approach aims to ensure market continuity and the availability of essential medical devices during the transition period to the new regulation.

MDR Transition Period Extension: FarmaImpresa Ensures Compliance for All its Legacy Devices

We have obtained the extensions of the MDR transition period beyond May 26, 2024, for our Class I, IIa, and III legacy devices. To this end, we have submitted a certification application to the notified body for our substance-based medical devices, confirming that the quality management system is MDR-compliant and currently in force.

Moreover, we have signed a contract with the notified body and are committed to maintaining compliance with Directive 93/42/EEC and to regularly carrying out surveillance activities for each legacy device.

Despite the automatic extension of the validity of the certificates by law, the notified bodies are not required to change the date of individual certificates or to issue additional documentation for the extended devices. However, the FarmaImpresa group can demonstrate compliance with the conditions of Article 120, paragraph 3, of the MDR through two documents: the confirmation letter from the notified body and a self-declaration from the manufacturer.

The confirmation letter from the notified body certifies that the body has received the MDR certification request, has signed a written agreement with the manufacturer, and specifies the applicable transition period dates for the devices. It also identifies the devices for which the MDR application has been received and clarifies whether the notified body is responsible for the surveillance of the devices corresponding to the applicable directive.

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