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 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. Price is predictable, without surprises.
  • Manufacturer accepts / rejects quotation
  • Signed quotation is sent to Sertio, planning of conformity assessment begins.
  • 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: 
  1. For all devices: Technical documentation summary or index, instructions for use, draft declaration of conformity 

  2. 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

  • Application together with supporting documentation is sent to Sertio for review. Contract between manufacturer and notified body is signed.
  • Notified body performs technical documentation review, including performance evaluation assessment.
  • Technical documentation needs to be submitted within 6 months from signing the contract.
  • Manufacturer provides response to possible identified deficiencies within 1 month.
  • 1st round of review needs to be completed before stage 2 onsite audit.

  • Stage 1 audit as off-site audit (docume t audit)
  • Stage 2  audit is conducted at headquarters and necessary site(s).
  • Audit report is issued by notified body
  • Manufacturer issues corrective actions towards possible nonconformities within the given timeframes as stipulated in terms of conformity assessment. 
  • 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

Send your details and receive an quote

Feedback / complaint

Kindly use this form to give us feedback. In case of appeal to a decision, kindly send signed letter to Sertio postal address 

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All conformity assessment services are subject to availability.