The MDD is one of the most complex of the EU's "new approach" directives.
It has 23 Articles and 12 Annexes. The Articles cover general items such as scope and definitions.
Annex I
lists the so-called Essential Requirements. All medical devices must comply with these requirements (where applicable). Manufacturers are required to check each product type or model against each requirement, determine whether the requirement is applicable, acquire documented evidence of compliance and keep this evidence available in the technical file of the product. There are good reasons to say that Annex I is the real core of the whole Medical Device Directive.
Annex II
describes the conformity assessment route known as the "full quality assurance system" option.
Annex III
describes the conformity assessment module called EC Type examination (type test). Please note that type-examination alone is not sufficient for the CE-certification. In addition, Annex IV, V or VI is needed.
Annex IV
deals with the module called EC Verification (inspection and approval of product batches).
Annex V
describes the module called Production Quality Assurance.
Annex VI
describes the module called Product Quality Assurance.
Annex VII
deals with instructions for self-certification of class I devices. Please note that this Annex also lists minimum requirements for the technical file.
Annex VIII
deals with devices for special purposes (such as custom-made products for individual patients).
Annex IX
gives the classification rules of medical devices. A very important Annex.
Annex X
gives general provisions for clinical evaluation of devices.
Annex XI
describes general criteria for Notified Bodies.
Annex XII
gives form and size requirements for the CE-mark.
