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TUV培训教材(MDD修改)

New Directive 2007/47/EC amending current Medical Directives

Directive 2007/47/EC amending MDD, AIMD and BPD

Website:

Directive 2007/47/EC amending MDD, AIMD and BPD

the laws, egulations and administrative provisions necessary to comply with this Directive.

They shall forthwith communicate to the Commission the text of those measures.

MDD

Directive 2007/47/EC amending MDD, AIMD and BPD

Medical Devices which are also considered Machinery have to meet the

essential health and safety requirements of the Machinery Directive as well.

e.g. X-Ray systems, CT Scanner Systems, Robotic Equipment

Directive 2007/47/EC amending MDD, AIMD and BPD

Software for medical purposes is a medical device

Directive 2007/47/EC amending MDD, AIMD and BPD

in the case of Implants

Directive 2007/47/EC amending MDD, AIMD and BPD

Whether or not a product falls under the definition of a medical device, it is in the interest of national market surveillance and the

establish a procedure for

Directive 2007/47/EC, Art.2 & Annex II amending MDD

including the software

Directive 2007/47/EC, Art.2 & Annex II amending MDD Software is now clearly defined as an active medical device.

Directive 2007/47/EC, Art.2 & Annex II amending MDD But Records of Implants must be retained for 15+ years

Directive 2007/47/EC, Art.2 & Annex II amending MDD Outsourced activities within the scope of the quality management system must

Directive 2007/47/EC, Art.2 & Annex II amending MDD Closer inspection of design documentation during audits

Directive 2007/47/EC, Art.2 & Annex II amending MDD

The commission shall submit a report to the European Parliament and

Directive 2007/47/EC, Art.2 & Annex II amending MDD

Registration of persons responsible for placing

Directive 2007/47/EC, Art.2 & Annex II amending MDD

Amended Data to be stored in a European database accessible to the

Directive 2007/47/EC, Art.2 & Annex II amending MDD

Added Provisions of article 14a shall be implemented no later than

Directive 2007/47/EC, Art.2 & Annex II amending MDD The Commission may, in accordance with the procedure referred to in article 7(2), determine the conditions under