EC says percentage of incomplete MDR applications increasing

The European Commission (EC) posted a July 25 update 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.

Survey respondents
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. Medical Design & Outsourcing