Updated European Commission Data Dashboard

By Annette van Raamsdonk

Earlier this year, we shared information about the European Commission (EC) dashboard, which will present data to show the availability of medical devices in the EU and the progression of transitions to the MDR and IVDR.

Gesundheit Österreich GmbH (Austrian National Public Health Institute) and Areté and Civic Consulting are responsible for the data collection. The study began in December 2022 and is expected to run for three years, until the end of 2025.

On May 13, 2024, Emergo by UL joined the Medical Device Coordination Group (MDCG) on behalf of the European Association of Authorized Representatives (EAAR) where new data was presented and included on the dashboard last week. 

What’s new on the dashboard?

The Notified Body (NB) survey data has been updated to include data retrieved during the January and March surveys this year. During these surveys, 100% of all MDR and IVDR-designated NBs responded.

An upward line is visible when looking at the percentage of issued MDR Quality Management System (QMS) certificates and product certificates, compared to the previously published percentages. A growth of 25% in certificates issued to the MDR, led to a total of 6,978 certificates, of which there were 2,331 product certificates (20 have been issued to Annex XVI devices) and 4,647 QMS certificates. Also, the number of applications made at NBs increased over the past months, up to 20,424.

Although these figures seem to indicate an upward trend, it is important to note that under the Medical Devices Directive 93/42/EEC (MDD) and Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) many more product certificates had been issued (21,376 valid product certificates had been issued under the MDD and AIMDD, which expired between January 2023 and May 26, 2024).

Status of the applications and reasons for refusal

The number of IVDR applications and IVDR QMS and product certificates is also increasing, though not as fast. Currently, 1,634 applications have been made and 798 QMS and product certificates have been issued. These are concerning numbers, considering that in October 2022, there were 1,551 valid product certificates issued to the In-Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD). In addition to those 1,551 certified IVDs under the IVDD, under the IVDR, around 80% of all previously self-certified IVDs, now require NB involvement.

Other interesting data that can be found on the updated dashboard, are the reasons for refusal of  MDR and IVDR applications by NBs. Still, most refusals of MDR applications are caused by manufacturers applying at an NB that does not have the devices in question in its scope. Manufacturers could easily avoid such refusals by, first making the classification assessment of their device according to the MDR, and then checking the scope of the NB on NANDO. IVDR application refusals are mainly caused by reasons such as non-resolved non-conformities, withdrawal of the application by the client or negative outcomes of the preliminary assessment.

Times to reach MDR or IVDR QMS and product certification have remained similar compared to previously presented timelines and have increased compared to the MDD/AIMDD/IVDD.  

Stakeholders foresee discontinuation of devices

In addition to the data retrieved from NBs, the updated dashboard will also reflect data retrieved from manufacturers within and outside the EU and EU Authorized Representatives (AR). A total of 658 replies (manufacturers and ARs) were analyzed. In our previous blog we mentioned that many stakeholders were either unable or unwilling to give input, as questions were vague and stakeholders preferred to use the time to work on their transition. This might have caused the limited number of replies.

An interesting fact is that the number of applications lodged by this group is higher than the number of applications received by the NBs. There is a difference in interpretation between this stakeholder group and NBs, on what “an application to an NB” entails.

Other questions that were covered by the survey were the estimated percentage of the manufacturer’s product portfolio foreseen to be transitioned. The outcome shows some shocking numbers, which many EU healthcare providers and patients are already concerned about.

Only 54% of the medical devices appear to be transitioned to the MDR and other devices are discontinued. Out of the 54% of transitioned devices, more than half of the medical device manufacturers indicate that they have transitioned less than 10% of their portfolio to the MDR.

For IVDs, the landscape in the EU seems drastically different.  Fewer than 40% of the IVDs appear to have transitioned to the IVDR. Out of this 40%, more than two-thirds of the IVD manufacturers indicate that less than 10% of this part of their portfolio has already transitioned to the IVDR. 

Other questions have arisen related to the costs manufacturers have to pay to get their Quality Management System (QMS) MDR-certified, as well as their device(s). Answers to these questions greatly vary, since these costs depend on many factors, such as the size of the company, location, presence and location of critical suppliers, complexity of the device and so on. What can be seen, is that costs for NB certification to the MDR and IVDR have risen.

Concluding remarks

Although the dashboard is updated to include more information, the information on new stakeholders reflects only a small group of manufacturers and ARs active in the EU market. There is still a significant lag in data. Nevertheless, the increase in transparency grows with each survey completed and included in the dashboard for analysis.

The next step is getting the survey conducted under healthcare providers, medical societies and medical doctors, to get data from this group about any shortage of devices.

We at Emergo by UL will update you once the dashboard is updated again and will continue to monitor this data and support clients with getting and keeping market access.

Need help with your application of device classification to the MDR or IVDR? Contact us.