Compliance

Demonstrating CE compliance with the AIMDD requires CE certification by a Notified Body, which involves some of the following:

1. Essential Requirements

        • General requirements (” The devices must be designed and manufactured in such a way, that their use does not compromise the clinical condition or the safety of patients.”)
        • Requirements regarding design and construction

2. Manufacturer appoints a European Authorized Representative (2007/47/EC Article 10a(2))

3. CE Declaration of Conformity (Complete quality assurance system)

        • Quality system
        • Examination of the design of the product
        • Surveillance
        • Administrative provisions(the declaration of conformity)

4. EC Type- Examination

        • Make an application for evaluation of quality system to a notified body (Annex III, section 3)

5. EC verification

6. EC Declaration of Conformity to Type

        • Quality system
        • Surveillance

7. Statement concerning devices intended for special purposes

8. Clinical evaluation

9. Minimum criteria to be met when designating inspection bodies to be notified

10. Conformity of CE marking

Restriction of Hazardous Substances Directive

The RoHS Directive 2011/65/EU that came in to force on the 21st July 2011 has placed a restriction on the use of certain substances in electrical and electronic equipment of manufactured products including medical devices. The RoHS Directive has listed substances and their percentage restrictions which will apply to all electrical and electronic equipment in Annex II of this Directive. From the 22rd July 2014, all electronic and electrical equipment contained in medical devices must comply with the restrictions established in this Directive.


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