IVDR CONFORMITY ASSESSMENT PROCEDURES

IVDR APPLICATION PROCEDURE

绍移Based on the product classification, the manufacturer must apply for an applicable conformity assessment procedure.

磨捂The application forms requesting detailed information can be accessed  

啥现Step-by-step information for each of the conformity assessment procedures (using the relevant Annex) is highlighted below. The graphics also provide an overview of the procedures for different device classes and types, as well as relevant surveillance activities. Specific device types require additional assessments, which are listed in the tables below.

敲鞠English and/or German are the only acceptable languages for the submission of documentation and any related correspondence.

棒论The certification costs are based on hourly rates and take into account factors such as the size of company, number of sites, and number and complexity of devices, etc.

拯奔+Refer to the  for the applicable products and procedures/annexes (see )

ANNEX IX

CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON THE ASSESSMENT OF TECHNICAL DOCUMENTATION

Chapter I: Quality Management System (QMS)

1. Application Management

• Customer enquiry with application form
• Non-binding quotation
• Purchase order
• Purchase order confirmation

• Development of an audit programme
• Customer submits company profile information
• Documentation review (company profile information, QM documentation etc.)
• Development of an audit plan
• On-site audit
• Audit report

3. Technical Documentation (for Classes B, C on sampling basis, n/a for specific types of devices)
佃琳 (Assessment of the technical documentation is performed before or during routine audits)

• Customer submits technical documentation
• Customer receives deficiency report (if applicable)
• Customer addresses deficiencies
• Performance evaluation assessment report released

• QMS certificate(s) issued

Chapter II: Assessment of Technical Documentation (additional for Classes D devices, incl. self-testing, near-patient-testing, Class C companion diagnostics; and Class B & C devices for self-testing, near-patient-testing)

• Customer enquiry with application form
• Non-binding quotation
• Purchase order
• Purchase order confirmation

2. Technical Documentation Assessment

• Customer submits technical documentation
• For CDx: send SSP to M-CA/EMA
• Customer receives deficiency report (if applicable)
• Customer addresses deficiencies
• For Class D (Annex IX Art. 4.9): verification of claimed performance by EU Reference Laboratory, including testing
• Technical documentation assessment report released

3. Certification

• EU technical documentation assessment certificate(s) issued

4. Annex IX, 4.12: verification of each manufactured batch of Class D devices (Batch verification, incl. testing at EU Reference Laboratory), including reporting of the decision to the manufacturer

ANNEX X 

Annex X in addition to Annex IX for classes D and C including

Self-Testing, Near-Patient-Testing and CDx, if applicable 

• Customer enquiry with application form
• Non-binding quotation
• Purchase order
• Purchase order confirmation

2. Assessment of Technical Documentation

• Customer submits technical documentation
• For CDx: send SSP to M-CA/EMA

• 松申Customer receives deficiency report (if applicable)

• Customer addresses deficiencies

• 欲虚For Class D: verification of claimed performance by EU Reference Laboratory, including testing

• 伐寡Partial report on technical documentation assessment

3. Testing

• Generate test plan
• Testing according to test plan
• Partial technical report(s) on testing

4. Certification

• EU-type-examination report released
• EU-type-examination certificate issued

5. Additionally required: conformity assessment according to Annex XI

ANNEX XI

CONFORMITY ASSESSMENT BASED ON PRODUCT QUALITY ASSURANCE

ANNEX XI for Class A-sterile without applying Annex X IVDR

ANNEX XI - in addition to Annex X for Classes D and C, including self-testing, near-patient-testing and CDx, if applicable 

1. Application Management

• Customer enquiry with application form
• Non-binding quotation
• Purchase order
• Purchase order confirmation

2. Auditing (Production QMS)

• Generate audit programme
• Customer submits company profile information
• Documentation review (company profile information, QM documentation etc.)
• Development of an audit plan
• On-site audit
• Audit report release

3. Technical Documentation (not applicable in cases where Annex XI is in addition to Annex X as this has already been assessed) - only for Class A (sterile)

候钟Please note: Assessment of the technical documentation is performed before or during the routine audits

• Customer submits technical documentation
• Customer receives deficiency report (if applicable)
• Customer addresses deficiencies
• Final report released

4. Certification

• EU Production Quality Assurance certificate(s) issued

5. Verification of each manufactured batch of Class D devices (Batch verification, incl. testing at EU Reference Laboratory), including reporting of the decision to the manufacturer