Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Class D IVDs: notified body assessment with EU reference laboratory

Spain, through the European Union route · Notified bodies · Diagnostics (IVD)

Device: conformity assessment by a certification bodyHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

Not published

Steps

9 requirements

Application fee

What is the Class D IVDs: notified body assessment with EU reference laboratory in Spain?

Class D in vitro diagnostic devices get the strictest assessment. The notified body reviews the quality system and technical documentation. Where an EU reference laboratory is designated, it verifies the claimed performance by laboratory testing and gives a scientific opinion within 60 days. For a first certification without common specifications, expert panels review the performance evaluation. Class D IVDs, such as blood, tissue and organ screening tests for transmissible agents.

What are the steps of the Class D IVDs: notified body assessment with EU reference laboratory?

1. Technical documentation and quality system; 2. Application to a notified body; 3. Notified body assessment; 4. EU reference laboratory verification (60 days); 5. Certificate issued; 6. Declaration of conformity, CE mark and registration.

Outcome: Notified body certificate, with batch verification by the notified body after certification.

Legal basis: Regulation (EU) 2017/746, Article 48(3) to (6); Article 100; Annex IX

How the pathway works

Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

About 60 days end to end with the official step targets. Targets, not actual times.

Steps

In order, with the official target for each step

1. Technical documentation and quality systemThe maker classifies the device, prepares technical documentation and puts a quality management system in place.
2. Application to a notified bodyThe maker lodges an application with a notified body designated for the device type.
3. Notified body assessmentQuality system audit and technical documentation assessment under the chosen annex route.
4. EU reference laboratory verification60 days, only in some casesWhere designated, an EU reference laboratory tests the device performance and gives a scientific opinion.
5. Certificate issuedCertificates are valid for the period stated, at most five years, and can be extended after reassessment.
6. Declaration of conformity, CE mark and registrationThe maker signs the EU declaration of conformity, affixes the CE mark and registers in the EU database.

Requirements

Official time targets

Targets, not actual review times

First review cycleregulation. Time for the EU reference laboratory scientific opinion. No legal time limit applies to the notified body review itself. Days shown are legal limits for specific consultations only.

60 days

Fees

Official amounts in the local currency

Fee	Amount
No fees published.

Other routes in Spain: Medical device software: qualification, classification and conformity assessment, Class A IVDs: maker's declaration of conformity, Class B IVDs: notified body conformity assessment, Class C IVDs: notified body conformity assessment. See all routes on the Spain page or explore them in the Regulatory section.

Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (17 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.

Other

Dossier format: technical documentation (Annexes II and III)Technical documentation as set out in Annexes II and III, assessed by the notified body.
Registration in EUDAMEDActor registration, device and UDI registration and the notified body and certificate modules of the EU database are mandatory since 28 May 2026.

Performance evaluation

Performance evaluationConformity with the safety and performance requirements, in particular performance characteristics, is shown through performance evaluation and clinical evidence.
Expert panel views on first certification(in some cases)When no common specifications exist and it is the first certification for that type of device, the notified body consults expert panels on the performance evaluation report.

Quality and manufacturing

Batch testingThe maker tests each manufactured batch and sends the reports to the notified body.

After approval

Periodic safety update reportClass D makers update the periodic safety update report at least every year.
Serious incident reportingThe maker reports serious incidents no later than 15 days after becoming aware of them, with shorter limits for serious public health threats and deaths.

Local presence

Authorised representative in the EUA maker not established in an EU country must name a single authorised representative before the device can be placed on the EU market.

Quality system

Person responsible for regulatory complianceThe maker has at least one person responsible for regulatory compliance with the required expertise.