European
Compliance Platform
European
Compliance Platform
The European Commission runs a public monitoring dashboard tracking Notified Body workload, certification timelines, and product availability across the MDR and IVDR system. Here's what it actually says — application backlogs, realistic timelines, and why a growing share of manufacturers are narrowing their EU product portfolios.
This is the European Commission's public monitoring dashboard for the availability of medical devices and in vitro diagnostic devices on the EU market. It is not a registry of individual devices — it's a market-level view of how the MDR and IVDR certification system is performing: how many applications are submitted, how many contracts are signed with Notified Bodies, how many certificates are issued, how long the process takes, and whether manufacturers are withdrawing products.
The dashboard was built as part of a study commissioned by DG SANTE through the European Health and Digital Executive Agency (HaDEA). Data is collected through voluntary surveys of Notified Bodies, manufacturers, authorised representatives, importers, distributors, and healthcare institutions.
Conventional medical devices: equipment, implants, instruments, consumables, and similar products regulated under MDR 2017/745.
Laboratory diagnostics: tests, reagents, analysers, glucose meters, and other products that examine samples outside the body, regulated under IVDR 2017/746.
An organisation designated to carry out conformity assessment and issue certificates where third-party assessment is mandatory.
Manufacturers, authorised representatives, importers, and distributors — collectively, the businesses responsible for placing devices on the EU market.
The dashboard lets you follow the full path: application → contract with an NB → technical documentation assessment → certificate.
These figures cannot be read as a simple funnel. A single application can cover multiple certificates, can relate to a change to an existing certificate, or can later be withdrawn by the manufacturer. So, for example, you cannot subtract the number of certificates from the number of applications and call the difference a "backlog."
The most recent full Notified Body survey covers data as of 28 February 2026 and was published on 3 July 2026. All 53 active bodies responded: 52 were designated under MDR and 19 under IVDR, with some bodies designated under both regulations.
| MDR | IVDR |
|---|---|
| 31,902 certification applications | 3,723 certification applications |
| 20,698 signed contracts with manufacturers | 1,813 signed contracts |
| 989 rejected applications | 145 rejected applications |
| 12,036 quality management system certificates | 1,040 QMS certificates |
| 6,203 product certificates | 1,302 product certificates |
The system is producing certificates at meaningful volume. But there is a long gap between submitting an application and getting a result.
Per the Notified Bodies' own reporting, a typical new MDR certificate takes roughly 13–18 months after the contract is signed — and that clock doesn't start until the contract stage is reached.
| Assessment scope | Share of MDR Notified Bodies |
|---|---|
| 13–18 months | 51% |
| 19–24 months | 31% |
| More than 24 months | 10% |
IVDR is somewhat faster: a QMS-only certificate is often issued in 6–18 months. For a combined QMS-plus-product assessment, 67% of IVDR Notified Bodies report 13–18 months, and 8% report 19–24 months.
The clock before the contract stage matters too. In the manufacturer survey, 42% of respondents reported more than three months between submitting an application and signing a contract with a Notified Body, and 24% reported more than six months.
The most consequential finding comes from the Commission's third survey, covering 201 economic operators: 152 medical device manufacturers and 49 IVD manufacturers.
48% (73 of 152) reported they had stopped supplying some devices to the EU market since 2021. Of those, 63% (46 of 73) said the revenue from the device no longer covered the cost of MDR re-certification. Other reasons: low sales volume, low profitability, and replacement by newer models.
61% (30 of 49) reported they had stopped supplying part of their range since 2022, and 45% (22 of 49) said they planned to discontinue further IVDs soon. Most common reasons: low sales volume, replacement by newer models, and end of product lifecycle.
This doesn't necessarily mean manufacturers are leaving the EU market entirely. More often, they are narrowing their portfolio to keep only the commercially justified devices — low-volume, older, or niche models become too expensive to re-certify under MDR/IVDR.
No — the data shows a more complicated picture than "Notified Body capacity shortage" alone. 92% of MDR Notified Bodies reported that manufacturers had asked to delay submission of technical documentation. For nearly all of those Notified Bodies, the delay had a real effect on scheduling: 44% reported a strong impact and a further 52% a noticeable impact.
Delays typically come from several sources at once:
"All delays are caused by a shortage of Notified Bodies" is an oversimplification the data doesn't support.
This is not EUDAMED, and not a catalogue of approved devices. You cannot use it to:
Verifying a specific device still requires the declaration of conformity, the certificate itself, manufacturer details, the Notified Body, the Basic UDI-DI, and registration records.
A large share of the underlying data also comes from voluntary surveys. For the manufacturer survey in particular, no true response rate can be calculated — the questionnaire was distributed through multiple channels and the number of manufacturers who actually received it is unknown. So it is not accurate to say "48% of all European manufacturers have withdrawn devices" — the correct statement is 48% of medical device manufacturers who responded to this particular survey. The Commission itself notes that figures may be revised, that presentation slides may differ from the live Power BI dashboard, and that the study's findings are not a separate legal opinion or an official Commission position on any specific device.
From 28 May 2026, the first four EUDAMED modules became mandatory: Actor registration, UDI/Device registration, Notified Bodies & Certificates, and Market Surveillance. This improves access to current certificate records, but it does not turn the monitoring dashboard into a product-level registry and does not replace checking an NB's legal designation scope in NANDO.
Submit your product details on ECP and we route your request to Notified Bodies, testing labs, and regulatory consultants who cover your specific device class — so you can compare real capacity and lead times instead of guessing.
See How ECP Can HelpSources checked 20 August 2026: European Commission, Study Supporting the Monitoring of Availability of Medical Devices on the EU Market; 20th NB and third EO survey publication; and EUDAMED overview. Figures are dated survey snapshots; refer to the Commission's live dashboard for later revisions.