How Long Does MDR/IVDR Certification Really Take? What the EU's Own Data Shows

What This EU Dashboard Actually Is

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.

Key Terms

What the Dashboard Actually Tracks

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single application can cover multiple certificates, can relate to a change to an existing certificate, or can later be withdrawn by the manufacturer.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 Numbers: MDR and IVDR Applications and Certificates

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.

The system is producing certificates at meaningful volume. But there is a long gap between submitting an application and getting a result.

How Long Does Certification Actually Take?

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.

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 Real Consequence: Manufacturers Are Narrowing Their Portfolios

The most consequential finding comes from the Commission's third survey, covering 201 economic operators: 152 medical device manufacturers and 49 IVD manufacturers.

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.

Is It Only the Notified Bodies' Fault?

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:

• Limited Notified Body capacity
• Lengthy contract negotiation
• Incomplete or under-prepared technical documentation
• Requests for additional clinical evidence
• Consultation procedures
• Manufacturers themselves postponing submission deadlines
• A manufacturer's economic decision not to continue certification at all

"All delays are caused by a shortage of Notified Bodies" is an oversimplification the data doesn't support.

What This Dashboard Does NOT Show

This is not EUDAMED, and not a catalogue of approved devices. You cannot use it to:

• Confirm the registration of a specific device
• Verify the validity of a specific certificate
• Establish whether a specific manufacturer complies with MDR or IVDR
• Prove that a device is lawfully placed on the market
• Determine the exact number of unique models on the EU market

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.

What Changed in EUDAMED in 2026?

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.

Practical Takeaways

1. Budget 18–24+ months for a new MDR Class IIb/III certificate from first Notified Body contact to certificate issuance — not from contract signature.
2. Start comparing Notified Bodies early and ask directly about current application backlog and lead times for your specific device class — this varies significantly between bodies.
3. Get technical documentation genuinely complete before applying — incomplete documentation is one of the most common, and most avoidable, sources of delay.
4. Model the economics per product before committing to re-certification — the survey data suggests low-volume or low-margin devices are the ones most often dropped after the fact.
5. Cite this data carefully — always give the survey date, respondent count, and survey type. Treat it as directional market evidence, not a complete census of the EU market.

Frequently Asked Questions

Sources 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.