May 26, once again!
May 26 is approaching and in 2025 marks another important date for the IVD sector. All IVD manufacturers who wish to continue selling legacy devices beyond this date are legally required to update their Quality Management System in accordance with IVDR Article 10(8). A specific QMS certification is not required. Manufacturers of high risk IVDs will be scrutinized according to the IVDR QMS during the surveillance audit. If a notified body is not involved then the QMS is only under the control of the manufacturer. Any market surveillance by a Competent Authority may focus on the QMS requirements.
The European Commission published a Q&A document about the latest IVDR amendment in July 2024 (available here). It is important to recognize the requirements for selling legacy devices after certain due dates. Many of our clients have already been contacted by customers (importers or distributors) inquiring whether their devices are still permitted for sale. Question 5 of the Q&A asks: “How can the manufacturer demonstrate that its legacy device benefits from the extension of the transitional period?” The answer given indicates that the manufacturer should provide a self-declaration confirming that the conditions for the extension are fulfilled, stating the end date of the transition period.
A template of the self-declaration has been prepared by MedTech Europe and is available on their website (see here). It covers the QM system according to the IVDR and confirms if the manufacturer has an agreement with an IVDR Notified Body as required for higher risk class IVD manufacturers. Even though this self-declaration is not legally required it is strongly recommended that every IVD manufacturer who is still selling legacy devices fills out the form as soon as possible.
On the same deadline May 26, 2025, an additional requirement applies for manufacturers of devices
- “which have a certificate that was issued in accordance with Directive 98/79/EC” (IVDD) or
- “for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body” and which fall under risk class D under IVDR 2017/746
a formal application must be lodged with the notified body! Details are found in IVDR Article 110(3c).
In other words, manufacturers of legacy devices with an IVDD Notified Body Certificate or devices which fall under IVDR risk class D have to take actions until May 26 this year.
- lodge an application with the Notified Body
- fill out the self-declaration (see above link)
- request a “confirmation letter” from the Notified Body (details can be found in the Q&A, but all Notified Bodies should know what confirmation letter they have to provide).
The proof should be provided and be available to your customers and should be on file with the Authorized Representative. MDSS is prepared to receive the proof at any time and will follow up upon the due date May 26, 2025.
The same proof will be required by May 26, 2026 for class C devices and May 26, 2027 for class B devices and sterile class A devices. These steps allow to market the legacy devices for additional 2.5 years.
- Class D – December 31, 2027
- Class C – December 31, 2028
- Class B and Class A sterile – December 31, 2029
We are wishing you every success in overcoming these challenges. May your transition be smooth and your continued presence in the European market thrive – we are here to support you every step of the way.