Case Study 2

1
Case Study 2

• Team Real

2
Product D Vivostat System, Class III

• Conformity Assessment Procedure
• Annex II with design examination
• Because QMS in place
• Preparation of a Design Dossier

3
Essential Requirements

• Meet 1 to 6
• 7 Chemical, physical, biological properties
• lit.review,
• 8 Infection and microbio contamination (EN552)
• 8.1 easy handling, 8.2 origin of animal
  substances (venom) is controlled
• 9 Construction and environmental properties
• 10.1 Accuracy of measuring function
• 12 Requirements for MD connected to or equipped
  with an energy source
• 12.7.1 protection of user 12.9 funtions and
  controls clearly specified
• 13 Information supplied by manufacturer

4
Contents of Design Dossier

• Description of QMS, aligned with ISO 13485
• Electronical safety, acc to ER 12
• Sub-dossier per component (processing unit,
  applicator, preparation unit)
• Materials (enzyme, buffers)
• Venom, avatim
• Labelling and instructions for use
• Risk management plan with risk analysis
• Summary

5
Product AContinence Control Device, Class I
(Rule 1)

• Annex VII, ie EC declaration of conformity
• QMS per ISO 13485
• Technical File as per Annex VII
• Description, drawings, method of manufacture
• Risk analysis, risk management
• Pre-clin evaluation (literature based)
• Clin evaluation
• Labelling
• Post-marketing surveillance

6
Product BHydrocolloid Dressing, Class III

• Annex I essential requirements (next slide)
• Annex II with design examination
• QMS with ISO 13485, application for QMS
  assessment by NB
• Design Dossier, incl declaration of conformity
• Post-marketing surveillance

7
Essential Requirements

• Meet 1 to 6
• 7 safe material (gelatine of animal origin),
  biocompatibility (also ISO 10993)
• 8 sterility, compliance of material of animal
  origin
• 9 Construction (low risk of injury)
• 10, 11, 12 not applicable (no measuring, no
  radiation, no energy source)
• 13 labelling

8
Product CFaecal Management System, Class IIa
(Rule 5)

• Comply with Annex II, incl conformity
  declaration, but without design dossier
• Annex I essential requirements
• 1 to 7
• 10 measurement function
• 8, 11, 12, not applicable
• 13 information supplied by manufacturer
• With full quality assurance acc. to ISO 13485
• Post-marketing surveillance