Newsletter No 45 May 2024

Subject: Extension of the MDR transitional period

 

On 26 May 2024 the MDR implementation enters a new stage. Let’s explore the key points that directly impact the medical device landscape.

Transitional period extension

The European Commission has extended the transitional period for the placement on the market of certain MDD-compliant devices, to facilitate a smooth MDD-MDR transition and to protect the patients from shortage of certain medical devices on the European market. But what does this mean for manufacturers and distributors? Which devices can benefit from the extension? We’ll explore the details.

Duration: The transition period is extended beyond the initial deadline of 26 May 2024.

Conditions: To benefit from this extension, manufacturers must fulfill specific conditions outlined in Article 120(3c) of the MDR:

  • Legacy devices must continue to comply with the MDD or AIMDD, as applicable.
  • There are no significant changes in the design or intended purpose of the device.
  • The devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health.
  • The manufacturer has put in place a quality management system according to MDR (Article 10(9)).

Demonstrating Eligibility: Manufacturers need to demonstrate that their legacy devices qualify for the extended transitional period by meeting the following conditions:

  • Application Deadline: Apply for MDR certification with an MDR Notified Body before 26 May 2024 and before their MDD certificate expires.
  • Notified Body Contract: Have a contract in place with an MDR Notified Body before 26 September 2024

How do manufacturers provide evidence of eligibility to the distribution chain? By providing a confirmation letter from their Notified Body with the scope of the devices in ongoing MDR certification process, together with a declaration issued by the manufacturer.

Devices with MDR declaration of conformity (and MDR EC certificate, when applicable): Devices that are class I non-sterile, no measuring function, and devices with MDR EC certificate are already placed on the market with EU Declaration of Conformity according to MDR and are therefore out of the scope of the MDD-MDR extension.

 

Role of the distributors

According to the MDR, before making a device available on the market distributors must verify that the device has been CE marked and that the EU declaration of conformity has been drawn up. If the declaration of conformity is according to MDD, the confirmation letter from the Notified Body together with the declaration from the manufacturer will confirm that the device is being placed on the market according to the extended transitional period.

This confirmation letter requirement does not affect to the successive distribution steps, after a device has lawfully been placed on the market under MDD declaration of conformity and respective MDD-EC certificate when applicable. For products already on the market, distribution is allowed until their expiry date.

Remember, this extension allows manufacturers and distributors more time to adapt to the new regulations and facilitate healthcare providers and patients access of medical devices during the implementation of the MDR.

This newsletter is part of our campaign to increase the sensitivity and the awareness of all our business partners, to bring more clarity around the MDR journey and challenges and opportunities around the MDR Art.22 “Systems and Procedure Packs”. 

We are already today all dependent on efficient cooperation. For the MDR implementation, we require even closer collaboration to ensure we all can deliver safe supplies to hospitals and patients in the future.

We are confident we will continue to supply health care competently on customized surgical procedure sets and small kits.

Do you wish to know more about specific MDR topics? Do you have any questions or comments about STS newsletter? Write us at MDR2020@stsmedicalgroup.com.

The next MDR newsletter will be issued in June.

Augusto Orsini
CEO STS Medical Group

Meritxell Laguna
Group Manager Regulatory Affairs
STS Medical Group