July 25, 2023
The European Commission (EC) posted an update (25 July 2023) on the current state of Medical Devices Regulation (2017/745 MDR) and In Vitro Diagnostics Devices Regulation (2017/746 IVDR) applications. The data collected was from a recent survey instrument intended to monitor and analyze the availability of devices on the EU market.
Study on medical devices and Notified Body survey instrument
The study was led by Gesundheit Österreich GmbH (Austrian National Public Health Institute) with Areté and Civic Consulting. The study started in December 2022 and will end in 2025.
The survey instrument to collect the most recent data on certificates issued and the number of applications received was shared with the Notified Bodies on April 3, 2023, and concluded May 5, 2023.
The collected data have been compared with data compiled by the EC between February 2021 and October 2022.
All Notified Bodies responded, resulting in a 100% response rate. This consists of 38 Notified Bodies designated to the MDR and 10 Notified Bodies designated to the IVDR. Of these 39 Notified Bodies, nine are designated to both the MDR and IVDR, 28 Notified Bodies are designated to the MDR only, and one Notified Body is designated to the IVDR only.
General survey results
The data (March 2023) reports 11,418 MDR applications and 2,951 MDR certificates, compared to the 23,156 MDD and AIMDD that were still valid at the same time. The number of MDR applications and issued MDR certificates has been steadily increasing.
The data is reported as QMS applications and certificates, Annex IX Chapter I or Annex XI Part A, or MDR Product Applications and Certificates, Annex IX Chapter II, Annex X or Annex XI Part B according to MDR (which can be compared with Annex II, including section 4 MDD). We would relate this as the conformity assessment routes for Class IIb to Class I measuring, sterile, and reusable surgical instruments or the conformity assessment route for Class III medical devices.
For Class IIb and lower risk, there have been 7,551 MDR applications and 1,954 MDR certificates. For Class III, there were 3,867 MDR applications and only 997 MDR certificates.
Results for the IVDR are similarly low. Only 950 applications have been received, and 331 IVDR certificates have been issued. And this is with over 80% of self-certified IVDD devices that will need Notified Body involvement under the IVDR: there were 1,551 valid IVDD certificates (October 2022).
Some alarming results
It would appear that the percentage of incomplete MDR applications has been increasing, as well as the time to receive the MDR certificate, with March 2023 compared to October 2022. In particular, for the MDR QMS and product certificates, for 86% of the certificates, the time required was greater than 13 months.
The IVDR application refusal data show that manufacturers appear to struggle with their applications. Reasons for refusal are incomplete data, wrong qualification and/or classification, and other reasons. The time it takes to get an IVDR QMS and product certificate issued in 60% of the cases is 13-18 months and 19-24 months in 30% of the cases.
Good news for those manufacturers that need Notified Body involvement or with an expiring certificate
The survey reports that it takes an average of 2-3 months from the time a submitted Notified Body application (lodged) to the time there is a signed written agreement. This is not a reason to further delay the process of engaging a Notified Body, though these results provide some optimism about the timing of this process, particularly in regard to Regulation 2023/607. It should be noted that Notified Bodies have already reminded manufacturers not to wait until the last moment with an application (May 26, 2024), as there is a risk that they will not be able to issue the MDR agreement before September 26, 2024.
Also, it appears that there are no IVDR applications rejected because of capacity. Notified Bodies are even actively requesting applications, as they have capacity.
The survey indicates that more manufacturers have submitted MDR applications and received MDR certificates. However, the number of incomplete MDR applications and the time to receive the MDR certificates has been increasing. The same can be observed for IVDR applications and certificates, only in smaller numbers.
It is imperative that medical device manufacturers submit complete MDR/IVDR applications. And, it is important that even with the additional transition time for medical device manufacturers afforded by Regulation 2023/607, submissions of the MDR applications should not be delayed. 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. In addition, if a manufacturer lacks experience or resources, consider engaging a consultancy such as Emergo by UL. Or, consider engaging Emergo by UL to review the drafted TDFs and assist with the Notified Body application.
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