• 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
• 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 fee is paid.

• Application together with supporting documentation is sent to Sertio for review. Contract between manufacturer and notified body is signed.

• Technical documentation (TD) needs to be English or Finnish language. 
• Technical documentation needs to be submitted within 6 months from signing the contract. Otherwise fee is included.
• Sertio sends TD request, completeness check list and documentatin upload link. 
• Notified body performs technical documentation review, including performance evaluation assessment.
• Manufacturer provides response to possible identified deficiencies within 1 month.
• 1st round of review needs to be completed before stage 2 onsite audit.
• Report is issued after TD review has been completed.

• Stage 1 audit as off-site audit (documet audit). Stage 1 can be done in parallel with TD review.
• 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. 
• Observations requiring corrections can arise at this point.
• Certification decision maker makes the certification decision based on recommendations.

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

EU QA certificate for 

• Class A sterile devices

Maximum period for EU certificate validity is 5 years.

Upkeep of EU certificate(s) 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.

• Recertification application. 
• renewal of contract between manufacturer and notified body. 
• Technical documentation assessment as applicable
• Recertification audit at site(s).
• Resolution of possible nonconformities
• New EU certificate(s) is issued.