• 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.
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• 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.