The European Commission published Regulation (EU) 2023/607, with new deadlines for medical device manufacturers to transition from the MDD to the MDR. The new deadlines range from May 2026 to December 2028, depending on the type of device and the current manufacturers’ agreements with the notified body. Read this article to learn the deadlines for different device classes.
- Class III custom-made implantable devices: 26 May 2026
- All other class III devices, class IIb implantable devices with some exceptions: 31 December 2027
- Class IIb devices with some exceptions, class IIa devices, class I devices placed on the market in sterile condition or with a measuring function: 31 December 2028
Reasons behind the EU MDR deadline extension
The extension of the MDR transition period is beneficial for medical device manufacturers because it gives them more time to comply with the new requirements and avoid potential shortages of medical devices in the EU market. It allows manufacturers to continue placing their medical devices on the market based on compliance with the MDD, while continuing to transition their devices to the MDR. Furthermore, this deadline extension benefits public health, as it reduces the risk of essential devices losing market access.
Deadlines for medical device manufacturers to comply with the EU MDR
The dates for certifying existing medical devices (those that still have valid MDD/AIMD certificates until 25 May 2024) according to the MDR have changed and vary depending on the product’s class:
|Existing medical devices
|– Class III custom-made implantable devices
|26 May 2026
|– All other class III devices
– Class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors
|31 December 2027
|– Class IIb devices other than those covered in the previous row
– Class IIa devices
– Class I devices placed on the market in sterile condition or with a measuring function
|31 December 2028
The following conditions must be met for medical device manufacturers to take advantage of the new deadlines:
- The design and intended purpose of the device must remain unchanged.
- The device must not pose an unacceptable risk to the health or safety of patients, users, other individuals, or any other aspect of public health protection.
- The manufacturer must have implemented a Quality Management System under Article 10(9) by 26 May 2024. (Read more about the role of the QMS in the MDR)
Application process to take advantage of the extension
Manufacturers must apply with a notified body by 26 May 2024, and sign a written agreement by 26 September 2024. The exception is if the Competent Authority has approved a deviation/exemption according to Article 59, paragraph 1, or Article 97, paragraph 1 of the MDR.
If medical device manufacturers do not sign this agreement, they must ensure that their devices are certified according to the MDR by the original deadlines. That can result in delays and additional costs. Therefore, it is important for manufacturers to act quickly and make sure they comply with the requirements in a timely manner.
A unique situation is for manufacturers that own an MDD certificate with one notified body and want to change the notified body for the MDR. In that case, the MDR-notified body can take over the periodic inspections covered by MDD certificates issued by another notified body, but only if there is an agreement between the two notified bodies and the manufacturer.
Deadlines for devices with expired MDD/AIMD certificates
If the device’s MDD/AIMD certificates were valid until 26 May 2021, but the certificate expired before the publication of this new Amending Regulation, the manufacturer can still benefit from the mentioned transition periods. This is an option only if they have submitted an application for MDR certification and signed an official written contract before the certificate expired according to the MDD/AIMD, or if the Competent Authority has approved a deviation/exemption according to Article 59, paragraph 1 or Article 97, paragraph 1 of the MDR.
Deadlines for devices under MDD/AIMD already placed on the market
The MDR no longer includes provisions on the availability of medical products under Article 120.4. Previously, it was stated that devices lawfully placed on the market pursuant to the MDD/AIMD prior to 26 May 2021 may continue to be made available on the market or put into service until 27 May 2025. As a result, medical devices already on the market under the Directives will continue to be available.
Deadlines for new devices
For new devices, there are no deadlines. All new medical devices must comply only with the MDR because the MDD/AIMD is no longer valid. Manufacturers should consult the regulation and seek guidance from notified bodies to determine the specific deadlines that apply to their devices.
How to prepare for the transition from the MDD to the EU MDR
Manufacturers should keep in mind that they cannot relax now, even with the extended deadlines. The extension was meant to provide them with some breathing room and make the compliance process less stressful. However, they still can’t afford to delay. Notified bodies are still under a lot of pressure, so it is essential to start communicating with them as soon as possible. It is also important to note that no product changes should be made during this transition period.
This white paper can be helpful in this process of transition from the MDD to the MDR: 8-step transition process from MDD to MDR.
Overall, Regulation (EU) 2023/607 represents a significant development in regulating medical devices in the EU. By extending the deadlines for implementing key requirements, this regulation will help ensure that medical device manufacturers have enough time to comply with these requirements, while also improving the safety and performance of medical devices in the EU.
To set your documents and policies compliant with the EU MDR and ISO 13485, without hiring a consultant, help yourself with this easy-to-use ISO 13485 & MDR integrated documentation toolkit.