Last year the European commission has collected the data from the survey conducted by Notified Bodies (NBs) on certifications and applications (MDR). The Survey was conducted in between June and October 2023.
Percentage increase in applications
As per the survey data collected by the European Commission. It is observed the number of applications for certification under the Medical Device Regulation (MDR) increased by 35% between June and October last year.
In the October survey, notified bodies disclosed 17,846 MDR submissions, which spiked up from 13,177 four months earlier.
The increase was accompanied by a 43% jump in MDR certificates, which climbed from 3,899 to 5,599 over the analyzed period. An analysis performed in April 2022 found there were just over 25,000 certificates issued under the various annexes of the old device directives.
MDR applications filed and certificates issued
| Month & Year | Total number of applications filed | Total number of certificates issued |
|---|---|---|
| Feb 2021 | 1,840 | 224 |
| Feb 2021 to May 2021 | 2,721 | 340 |
| May 2021 to Sep 2021 | 3,920 | 502 |
| Sep 2021 to Apr 2022 | 6,188 | 1,069 |
| Apr 2022 to Oct 2022 | 8,120 | 1,990 |
| Oct 2022 to Mar 2023 | 10,818 | 2,951 |
| Mar 2023 to Jun 2023 | 13,177 | 3,899 |
| Jun 2023 to Oct 2023 | 17,846 | 5,599 |
Percentage increase in applications and Certificates
| Month & Year | Percentage increase in applications filed | Percentage increase certificates issued |
|---|---|---|
| Jun 2023 to Oct 2023 | 35% | 43% |
MDR applications and certificates by survey comparison for the month of October 2023
| Survey Comparison | Month & Year | MDR Applications | MDR Certificates |
|---|---|---|---|
| By Annex | October 2023 | 14.768 | 5.599 |
| By QMS vs Product | October 2023 | 14.768 | 5.599 |
Rejection Numbers
The total number of MDR applications that are rejected in between October 2022 to October 2023 mentioned in numbers
| Month & Year | Total number of MDR applications | Application Rejected |
|---|---|---|
| October 2022 | 8120 | 232 |
| March 2023 | 11418 | 269 |
| June 2023 | 13177 | 328 |
| October 2023 | 17846 | 396 |
The major reason for Rejection
Main reasons are as follows:
| Main Reasons for Rejection | October 2022 | March 2023 | June 2023 | October 2023 |
|---|---|---|---|---|
| Outside the scope of Notified body (NB) Designation | 66 | 208 | 304 | 203 |
| Application file is not completed | 24 | 28 | 176 | 124 |
Other Reasons for Rejection:
The reasons for the notified body rejection are mentioned as follows
- Outside the scope of notified body’s designation
- Application not complete
- Wrong qualification of product/classification of device
- Other
- Insufficient notified body resources
- Wrong conformity assessment procedure