Conformity Assessment

Conformity Assessment is the comprehensive process by which medical device manufacturers demonstrate compliance with the essential requirements of the EU Medical Device Regulation (MDR 2017/745). This process is fundamental to obtaining CE marking and legally placing devices on the European market.

Legal basis and purpose:

Under EU MDR Article 52, manufacturers must demonstrate conformity with the General Safety and Performance Requirements (GSPR) set out in Annex I of the regulation. Conformity assessment provides the systematic framework for this demonstration, ensuring devices are safe, perform as intended, and meet all applicable regulatory requirements before entering the market.

The relationship to CE marking:

Conformity assessment is the process that leads to CE marking:
1. Manufacturer completes conformity assessment following applicable procedures
2. Manufacturer prepares EU Declaration of Conformity (DoC)
3. Manufacturer affixes CE mark to device
4. Device may be legally placed on EU market

The CE mark itself is not a certification - it is the manufacturer's declaration that conformity assessment has been successfully completed.

Conformity assessment routes based on device class:

The EU MDR defines different conformity assessment procedures based on device risk classification:

Class I devices (general, non-sterile, non-measuring):

Conformity assessment route: Self-declaration (no Notified Body involvement)

Process:
- Manufacturer establishes technical documentation per Annex II or III
- Manufacturer implements Quality Management System per ISO 13485
- Manufacturer prepares Clinical Evaluation Report (CER)
- Manufacturer conducts conformity assessment per Annex IV (self-declaration)
- Manufacturer drafts EU Declaration of Conformity
- Manufacturer affixes CE mark

No Notified Body involvement or certification required.

Timeline: 6-12 months (depending on preparedness)

Class I sterile and/or measuring devices:

Conformity assessment route: Notified Body involvement for specific aspects

Process:
- Manufacturer completes technical documentation
- Notified Body certification required for sterile aspect (sterilization validation) per Annex II Section 6.1
- Notified Body certification required for measuring function (metrology) per Annex II Section 6.2
- Manufacturer completes remaining conformity assessment through self-declaration
- EU Declaration of Conformity and CE marking

Partial Notified Body involvement for sterile/measuring aspects only.

Timeline: 12-18 months

Class IIa and IIb devices:

Conformity assessment routes: Notified Body certification required

Manufacturers can choose between different conformity assessment procedures:

Option 1: EU technical documentation assessment + QMS assessment (Annex IX Chapters I + III)

Annex IX Chapter I - QMS assessment:
- Notified Body audits manufacturer's Quality Management System
- Covers design, manufacturing, packaging, labeling, post-market surveillance
- Initial audit followed by surveillance audits (typically annual)
- QMS certificate issued valid up to 5 years

Annex IX Chapter III - Technical documentation assessment:
- Notified Body reviews representative sample of technical documentation
- For Class IIa: Representative sampling of technical documentation
- For Class IIb: More extensive technical documentation review
- Assessment of compliance with GSPR
- Certificate issued for devices covered by technical documentation review

Option 2: Type examination + QMS for production (Annex X + Annex IX Chapter II)

Annex X - EU type examination:
- Notified Body examines design of the device
- Review of complete technical documentation for representative device
- May include physical examination and testing
- EU type examination certificate issued for specific device design

Annex IX Chapter II - Conformity to type based on QMS:
- Notified Body audits manufacturing quality management system
- Focus on production, packaging, labeling, releasing for market
- Ensures production matches approved type examination
- Production QMS certificate issued

Less commonly used for Class IIa/IIb, but available option.

Timeline for Class IIa/IIb: 12-24 months

Class III devices:

Conformity assessment routes: Most rigorous Notified Body involvement

Option 1: Full QMS assessment + Technical documentation (Annex IX Chapters I + III) - Most common

Annex IX Chapter I - QMS assessment:
- Comprehensive audit of entire Quality Management System
- Design controls, risk management, clinical evaluation, production, post-market surveillance
- Initial certification audit followed by annual surveillance
- QMS certificate covering all aspects of device lifecycle

Annex IX Chapter III - Technical documentation assessment:
- Design examination of technical documentation for each device
- Notified Body reviews complete technical file
- Assessment of design, safety, clinical evaluation, risk management
- Certificate issued for specific device

This is the most commonly used route for Class III devices, providing comprehensive Notified Body oversight of both QMS and device design.

Option 2: EU type examination + QMS for production (Annex X + Annex IX Chapter II)

Annex X - EU type examination:
- Notified Body thoroughly examines device design
- Comprehensive review of technical documentation
- May include design verification testing
- Type examination certificate for approved design

Annex IX Chapter II - Conformity to type:
- QMS assessment focused on manufacturing and production
- Ensures manufactured devices conform to type-examined design
- Production quality controls and batch release procedures

Less common for Class III but available.

Option 3: Full QMS assessment alone (Annex XI) - Least common

Annex XI - Full Quality Assurance:
- Single comprehensive QMS assessment covering design, development, production, and post-market
- Notified Body audits entire device lifecycle quality system
- Most extensive QMS requirements
- Design dossier submitted to Notified Body for review
- Less commonly used in practice due to complexity

Timeline for Class III: 24-36+ months

Key components of conformity assessment:

Regardless of route, conformity assessment requires:

1. Technical Documentation (Annex II or III):

Annex II - Full Technical Documentation:
Required for Class IIa, IIb, III devices and contains:
- Device description and specifications
- Risk management file (ISO 14971)
- Benefit-risk analysis
- Product verification and validation
- Clinical Evaluation Report (CER)
- Post-Market Clinical Follow-up (PMCF) plan
- Labeling and Instructions for Use
- Manufacturing information
- Post-Market Surveillance plan

Annex III - Technical Documentation on Post-Market Surveillance:
Simplified documentation allowed for certain Class I devices.

2. Quality Management System (ISO 13485):

Manufacturers must establish, document, and maintain a QMS per ISO 13485:
- Management responsibility and quality policy
- Design and development controls
- Purchasing and supplier controls
- Production and process controls
- Monitoring and measurement (including product release)
- Corrective and preventive action (CAPA)
- Internal audits
- Management review

For Notified Body QMS assessment, the NB audits conformity with ISO 13485 and MDR QMS requirements.

3. Clinical Evaluation Report (CER):

Comprehensive evaluation of clinical data per Annex XIV and MEDDEV 2.7/1 Rev 4:
- Literature review and clinical investigation data
- Analysis of safety and performance
- Benefit-risk determination
- Conclusions supporting device conformity with GSPR

CER is critical component reviewed during technical documentation assessment.

4. EU Declaration of Conformity (DoC):

Formal declaration by manufacturer stating:
- Device conforms to applicable EU regulations
- Identification of device and manufacturer
- Reference to harmonized standards applied
- Notified Body details (if applicable)
- Signature by authorized representative of manufacturer

The DoC is the legal document enabling CE marking.

Notified Body selection and engagement:

Notified Body designation:
- Notified Bodies are independent organizations designated by national competent authorities
- Must be competent for specific device types and classification
- Designated for specific Annexes (e.g., Annex IX, X, XI)
- Notified Body number (4-digit identifier) appears on certificates and may appear on device labeling for certain classes

Selecting a Notified Body:

Considerations:
- Designation for your device type and class
- Expertise and experience with similar devices
- Review timelines and workload
- Geographic location and language capabilities
- Reputation and customer references
- Cost of certification services

Notified Body obligations:

Once engaged, the Notified Body:
- Reviews technical documentation for compliance with MDR
- Conducts on-site audits of Quality Management System
- Issues certificates of conformity (valid up to 5 years)
- Conducts surveillance activities (typically annual audits)
- Reports to competent authorities and EUDAMED
- Monitors post-market performance and may suspend/withdraw certificates

Conformity assessment process timeline:

Typical timeline by class:

Class I (general): 6-12 months
- Technical documentation preparation: 4-8 months
- Self-declaration and DoC: 1-2 months
- No Notified Body delays

Class I (sterile/measuring): 12-18 months
- Technical documentation: 6-10 months
- Notified Body review (sterile/measuring aspects): 3-6 months
- Self-declaration and DoC: 1-2 months

Class IIa: 12-18 months
- Technical documentation and QMS preparation: 6-10 months
- Notified Body QMS audit and technical documentation review: 4-6 months
- Certificate issuance and DoC: 1-2 months

Class IIb: 18-24 months
- Technical documentation, CER, and QMS: 8-12 months
- Clinical investigation (if required): 6-12 months (parallel)
- Notified Body assessment: 6-8 months
- Certificate and DoC: 1-2 months

Class III: 24-36+ months
- Technical documentation, comprehensive CER, QMS: 10-14 months
- Clinical investigations (often required): 12-24 months
- Notified Body design examination and QMS assessment: 8-12 months
- Certificate and DoC: 1-2 months

Timelines vary based on device complexity, clinical data availability, manufacturer preparedness, and Notified Body workload.

Challenges in conformity assessment:

Common obstacles:

1. Technical documentation gaps:
- Insufficient clinical evidence requiring additional studies
- Incomplete risk management file
- Inadequate verification and validation data
- Missing or outdated references to standards

2. Notified Body delays:
- High workload and long review queues
- Requests for additional information extending timelines
- Changes in Notified Body requirements or interpretation
- Notified Body designation issues or capacity constraints

3. Clinical data requirements:
- Insufficient literature for equivalence demonstration
- Need for clinical investigations extending timeline
- PMCF plan not adequately addressing data gaps
- Benefit-risk analysis lacking robustness

4. Quality management system deficiencies:
- QMS not fully implemented at time of audit
- Non-conformities identified during Notified Body audit
- Design control weaknesses
- Post-market surveillance systems inadequate

Post-certification obligations:

After conformity assessment and CE marking:

Ongoing compliance:
- Maintain conformity with MDR throughout device lifecycle
- Update technical documentation as design changes occur
- Conduct periodic CER updates (annually for Class III, every 2 years for IIb)
- Implement Post-Market Surveillance and vigilance reporting
- Maintain QMS and undergo Notified Body surveillance audits

Certificate renewal:
- Certificates valid up to 5 years
- Renewal requires Notified Body reassessment
- Technical documentation and QMS must remain current
- Renewal process typically initiated 6-12 months before expiry

Significant changes:
- Design changes may require new conformity assessment or notification to Notified Body
- Manufacturer must evaluate impact of changes and determine if new assessment needed
- Notified Body may require review and approval before implementing changes

Harmonized standards and conformity assessment:

Role of harmonized standards:

Compliance with harmonized standards (e.g., ISO 13485, ISO 14971, IEC 60601 series, ISO 10993) provides presumption of conformity with corresponding MDR requirements.

Benefits:
- Simplifies demonstration of conformity
- Widely recognized by Notified Bodies
- Reduces need for custom justification of design approaches
- Facilitates international harmonization

Standards typically applied:
- ISO 13485 - Quality Management Systems
- ISO 14971 - Risk Management
- IEC 62304 - Medical Device Software Lifecycle
- ISO 10993 series - Biocompatibility
- IEC 60601 series - Electrical Safety and EMC
- Many device-specific standards

Difference between MDD and MDR conformity assessment:

Under Medical Devices Directive (MDD 93/42/EEC) - legacy:
- Simpler technical documentation requirements
- Less stringent clinical evaluation expectations
- Notified Body processes less demanding
- Shorter timelines

Under Medical Device Regulation (MDR 2017/745) - current:
- More comprehensive technical documentation (Annex II/III)
- Rigorous clinical evaluation following MEDDEV 2.7/1 Rev 4
- Notified Body heightened scrutiny and detailed assessments
- Longer timelines and increased costs
- Post-Market Clinical Follow-up (PMCF) required
- Unique Device Identification (UDI) mandatory
- EUDAMED registration requirements

MDR transition has significantly increased conformity assessment burden and timelines.

Global conformity assessment comparison:

EU MDR conformity assessment vs. FDA clearance/approval:

EU (MDR):
- Notified Body (third-party) conducts conformity assessment
- Standards-based approach
- QMS audit central to assessment
- Clinical evaluation focuses on literature and equivalence (Class IIa/IIb)

USA (FDA):
- FDA (government agency) reviews submissions
- Predicate-based approach (510(k) substantial equivalence)
- QMS inspections separate from premarket review
- Clinical trials often required for PMA (Class III)

Both achieve similar goals (ensuring device safety and performance) through different mechanisms.

Conformity assessment is the cornerstone of the EU medical device regulatory framework. Success requires thorough preparation of technical documentation, robust quality systems, comprehensive clinical evaluation, and effective collaboration with Notified Bodies to demonstrate device compliance with the Medical Device Regulation's stringent requirements.