The EU Commission asks that manufacturers and EU Authorized Representatives (ARs) participate in the following survey: “Study supporting the monitoring of availability of medical devices on the EU market”.

If you would like to contribute, the link to the survey is: HERE

Overview of Survey

The purpose of the survey is to better understand the availability of medical devices & IVDs on the market, in relationship to the implementation of the MDR/IVDR. There are ever growing concerns about potential shortages of medical devices on the EU market.

The EU Commission requests that all manufacturers and EU ARs participate – those with MDD/AIMDD/IVDD legacy devices, and those with MDR/IVDR devices that are planned to be placed on the market in the next two years.

Additional notes:

• It is a recurring survey, so questions and scope may change in future versions.
• Please only provide one answer per company, i.e., check with your colleagues so that only one employee is answering on behalf of the entire organization.
• The survey deadline is Monday, 15 January 2024.
• A glossary of terms used in the survey, is available: HERE

The glossary of terms, linked above, is a useful reference in general. It includes definitions for ~50 terms, such as what constitutes a small-to-medium sized enterprise, common specifications, importer, market surveillance, generic device group, system/procedure pack producer, and more.

Concerns re: MDR/IVDR Transition

Medical Device Coordination Group (MDCG)

The updated MDCG 2022-11 rev. 1 to include several calls to action:

1. Notified Bodies to streamline the certification process
2. Manufacturers to transition to the Regulations and submit their applications without further delay

The June 2023 Notified Body survey still shows:

“…limited progress in terms of applications submitted and certificates issued. Compared to the over 24.000 certificates issued under Directives 90/385/EEC and 93/42/EEC, only around 13.000 MDR applications have been lodged and 3.900 certificates have been issued…

Moreover, out of those 3.900 issued MDR certificates, around 1.000 are related to updates. This shows that manufacturers tend to transfer at different times devices to be included in the same certificate. Whilst this approach is understandable, it might create issues in planning and in the capacity of notified bodies.

The situation is even more worrisome for IVDs. While only around 8% of IVDs required notified body involvement for conformity assessment under Directive 98/79/EC on in vitro diagnostic medical devices (IVDD), this proportion is around 80% under the IVDR. Nonetheless, compared to around 1.500 certificates issued under the IVDD (representing a small fraction of the number of certificates expected under the IVDR), by June 2023 only 1.150 applications have been lodged under the IVDR and around 500 certificates have been issued…”

EU Competent Authorities for Medical Devices (CAMD)

The CAMD’s 53^rd Meeting Statement, from 20 November 2023, states:

“A follow-up of the applications numbers for MDR/IVDR and certificates issued under those regulations was also presented during this session…Those numbers showed not to be satisfying even 6 months after the regulation 2023/607 publication. Competent authorities remind manufacturers to make the best possible use of the extra time granted by the transitional periods adapting their quality systems and devices to the MDR and IVDR requirements and submit complete applications to the notified bodies. All actors should join forces to avoid shortages of medical devices and the subsequent risks for patients.”

Individual Competent Authorities

National Competent Authorities (CAs) are also raising alarms. For example, the French CA’s statement, supported by the Belgian, German, Irish and Italian delegations:

“In view of the approaching deadlines for the implementation of MDR (submission of files no later than 26 May 2024) and IVDR (submission of dossiers in December 2023 for class D IVDs, the most at risk), France is particularly concerned about:

• The risk of supply disruptions for medical devices and IVDDs, notably due to a lack of visibility on the nature of the devices for which applications have been submitted by manufacturers and on their plans to stop marketing;
• The system’s lack of preparation, particularly following the further postponement of the production launch of Eudamed, for which a rapid solution must be proposed.

The difficulties encountered by small and medium-sized companies in both sectors (medical devices and IVDDs) pose a real threat of supply disruptions and the disappearance of medical devices and IVDDs from the European market, with consequences for patient care in all EU Member States. What’s more, the Eudamed database, which was meant to contain all the information on products, is still not operational, so there is no visibility of the market. This also contributes to the lack of harmonisation of vigilance and market surveillance procedures.”