IVDR NB Certification
IVDR notified body services
IVDR Annex IX conformity assessment service for
- Class D
- Class C
- Class B
- Class A sterile devices
IVDR Annex XI conformity assessment service for
- Class A sterile devices
Confirmation that we are authorised to perform the Conformity Assessment of In Vitro Diagnostic Medical Devices in accordance with the EU IVD regulation and the scope of activities can be found on NANDO database.
Sertio Oy accepts documentation from manufacturer only in only English and Finnish.
Overview of conformity assessment process
- Manufacturer determines the conformity assessment route.
- Manufacturer fills in quotation request form.
- Notified body reviews the quotation request, compiles preliminary TD assessment plan and performs resource planning.
- Notified body issues quotation
- Manufacturer accepts / rejects quotation
- Contract is signed
- Manufacturer submits application for conformity assessment
- As part of the application, manufacturer submits attachment to application containing product list, QMS documents AND TD documents as follows:
For all devices: Technical documentation summary or index, instructions for use, draft declaration of conformity
Full TD for: class D devices, companion diagnostic devices, devices for self testing and near patient testing
Application is signed by authorized person of manufacturer
- Documentation shall be in English or Finnish.
- Notified body performs technical documentation review.
- Performance evaluation assessment
- Manufacturer provides response to possible identified deficiencies.
- Initial audit is conducted at headquarters and necessary site(s).
- Audit report is issued by notified body
- Manufacturer issues corrective actions towards possible nonconformities
- Final review process takes place by NB
- Certification decision maker makes the certification decision based on lead auditor, internal clinician, product reviewers and final reviewers recommendation.
EU QMS certificate, for
- Class A sterile,
- Class B,
- Class C,
- Class D
EU Technical documentation assessment certificate, for
- Class D devices,
- Devices for self testing,
- Devices for near patient testing,
- Devices for companion diagnostics
Maximum period for EU certificate validity is 5 years.
Upkeep of EU certificate requires
- Annual technical file sampling and surveillance audits.
- Notification of substantial changes to QMS or devices prior to implementation to NB
- Unannounced audit is performed at least once during certification period.
- Technical documentation assessment
- Recertification audit at site(s).
- New EU certificate(s) is issued.
Information about issued, suspended and canceled certificates as well as validity confirmation of a specific certification are available upon request.
Article 16 QMS assessment
Importers and distributors intending to relabel and / or repackage an IVD device require QMS assessment from EU notified body. This service is available from Sertio Oy.
Download price list from the button "DOWNLOAD Price...retio.pdf" below
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All conformity assessment services are subject to availability.