November 15, 2023
Recent data issued by the European Commission (EC) shows that Notified Bodies are reporting increasing numbers of applications and certifications related to the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), but that numbers of refused applications are also on the rise.
The EC has updated (dated October 25, posted November 9, 2023) the current state of MDR and IVDR applications with Notified Bodies. This is an update to the results posted on data through March 2023.
The PowerPoint Presentation (pdf) is presented in three sections: About, Medical Devices, and IVDs. In the future, the EC will launch a publicly accessible dashboard that enables the review of the most current data on Notified Body information and device certificates, as is currently presented in the PowerPoint presentation.
Study on medical devices and Notified Body Survey Instrument
While the background to the study was previously presented in the spring, this information has now been formally reported in the About section.
The survey instrument was distributed in July 2023. The data requested was through the end of June 2023. There is the qualification that some of the data is from a small dataset (six indicators posed every two months) or from a medium dataset (every four months).
All the Notified Bodies designated to the MDR and IVDR participated (100% response rate). The number of Notified Bodies from the March data increased by one, as one Notified Body designated to both the MDR and IVDR was added.
MDR survey results
The data (June 2023) reports 13,177 MDR applications and 3,899 MDR certificates (page 12). Compared to the March 2023 data of 11,418 MDR applications and 2,951 MDR certificates.
Most of the refusals (page 17, 75%) occurred because the scope exceeded the designation of the Notified Body or the application was incomplete. Incomplete applications remain an issue (page 18). The majority of Notified Bodies (page 19, 71%) say that the time to secure an MDR product certificate is more than 13 months.
This version of the study reported on six indicators (page 25) and compared the numbers between the four surveys. The indicators were favorable, such as the number of written MDR agreements and the number of MDR product certificates issued the first time, as well as negative, such as the number of MDR applications refused. All six indicators increased in percentage with time.
Also, new is data on the use of Annex XVI and products without a medical purpose. It’s Interesting to note that the number of applications for these devices has increased over the past few months.
IVDR survey results
The data (June 2023) reports 1,155 IVDR applications and 500 IVDR certificates (page 29). This is compared to the March 2023 data of 950 IVDR applications and 331 IVDR certificates.
As the deadline for legacy IVDs, which are classified up as Class D, approaches (May 26, 2025), the number of applications (231) and certificates (62) remains alarmingly low (page 30). Incomplete applications are the reason for the majority of the refusals (page 33, 75%). The survey data shows that 90% of the Notified Bodies (page 35) report that IVDR product certificates require greater than 13 months, with 40% of the Notified Bodies signaling that this is between 19 to 24 months.
Similar to the MDR, the six indicators for the IVDR, increased with time (page 38).
Both MDR and IVDR applications and issued MDR and IVDR certificates have been steadily increasing. With this, the number of refused applications is increasing as well. Incomplete applications remain a concern and the time for Notified Bodies to review is over one year and often greater.
Manufacturers are encouraged to commence their MDR and IVDR compliance journeys now. The Notified Bodies have reported that they have capacity. Team-NB has published official calls to action for both the MDR and IVDR.
Now is the time to apply to your Notified Body designated to the MDR and IVDR. Suppose you want to capitalize on Regulation 2023/607 for the legacy device. In that case, you have until May 26, 2024, to file a Notified Body application, and until September 26, 2024, to confirm there is a formally signed contract. Notified Bodies warn of an expected increase in applications as May 2024 approaches and cannot guarantee that applications made at the last moment can be reviewed in time to ensure a contract is in place before the September deadline.
Emergo by UL advises that manufacturers review the guidance provided by their Notified Bodies as well as the Team NB Best Practice Guidance on the MDR Technical Documentation File (TDF) and similar guidance for the IVDR TDF.
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