Class I:

Class I s/m:

Annex VII (EC Declaration of Conformity)

Annex VII (EC Declaration of Conformity) coupled with either

• Annex II (Full Quality Assurance), or
• Annex V (Production Quality Assurance).

 The application of these Annexes and Notified Body intervention being limited to those aspects of manufacture concerned with securing and maintaining sterile conditions, respectively conformity of products with metrological requirements.

Class IIa:

Annex VII (EC Declaration of Conformity) coupled with either

• Annex IV (EC Verification),  or
• Annex V (Production Quality Assurance), or
• Annex VI (Product Quality Assurance);

alternately, SOLELY Annex II (Full Quality Assurance System) may be applied without application of Section 4.

Class IIb:

Annex III (EC Type Examination) coupled with either

• Annex IV (EC Verification),  or
• Annex V (Production Quality Assurance), or
• Annex VI (Product Quality Assurance);

alternately, SOLELY Annex II (Full Quality Assurance System) may be applied without application of Section 4. 

 Class III:

 Annex III (EC Type Examination) coupled with either

• Annex IV (EC Verification), or
• Annex V (Production Quality Assurance);

alternately SOLELY Annex II (Full Quality Assurance System) may be fully applied.