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 III devices: notified body conformity assessment

Spain, through the European Union route · Notified bodies · Medical devices

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 III devices: notified body conformity assessment in Spain?

Class III devices need a full notified body assessment, with the technical documentation of each device reviewed. Clinical investigations are generally required for class III and implantable devices. For class III implantable devices, the notified body consults an expert panel on its clinical evaluation assessment. Class III medical devices, such as implants in contact with the heart or central nervous system and devices with an ancillary medicinal substance.

What are the steps of the Class III devices: notified body conformity assessment?

1. Technical documentation and quality system; 2. Application to a notified body; 3. Notified body assessment; 4. Clinical evaluation consultation with an expert panel (class III implantable) (21 days); 5. Expert panel scientific opinion; 6. Certificate issued; 7. Declaration of conformity, CE mark and registration.

Outcome: Notified body certificate, then the maker's EU declaration of conformity and CE marking.

Legal basis: Regulation (EU) 2017/745, Articles 52(3), 54 and 61(4); Annexes IX to XI

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 81 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. Clinical evaluation consultation with an expert panel (class III implantable)21 daysThe notified body sends its clinical evaluation assessment to an expert panel. The panel says within 21 days whether it will give a scientific opinion.
5. Expert panel scientific opinionup to 60 days, only in some casesIf no opinion arrives within 60 days, the notified body may proceed with certification.
6. Certificate issuedCertificates are valid for the period stated, at most five years, and can be extended after reassessment.
7. Declaration of conformity, CE mark and registration

Official time targets

Targets, not actual review times

First review cycleregulation. Expert panel consultation for class III implantable devices: if no opinion arrives within 60 days, the notified body may proceed. 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: Class I devices: maker's declaration of conformity, Class I sterile, measuring or reusable surgical devices, Class IIa devices: notified body conformity assessment, Class IIb devices: notified body conformity assessment, Medical device software: qualification, classification and conformity assessment, Device with an ancillary medicinal substance: medicines authority consultation, 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 (18 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.

Requirements

What the applicant must provide or meet

Other

Dossier format: technical documentation (Annexes II and III)Technical documentation and post-market surveillance documentation as set out in Annexes II and III of the regulation. There is no common EU summary format such as STED in the law.
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.

Clinical evaluation

Clinical evaluationConformity with the general safety and performance requirements and the benefit-risk ratio is based on clinical data.

Clinical data

Clinical investigationsClinical investigations are performed for implantable and class III devices, except in limited cases such as modified devices shown to be equivalent to the maker's own marketed device.

Quality system

Full quality assurance routeAnnex IX, or type examination (Annex X) with product conformity verification (Annex XI).
Person responsible for regulatory complianceThe maker has at least one person responsible for regulatory compliance with the required expertise.

After approval

Periodic safety update reportClass IIb and class III makers update the periodic safety update report at least every year. Class IIa makers update it when needed and at least every two years.
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.