The Structure of the Medical Device Directive 93/42/EEC

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, placing products on the market and putting them into service, free movement of CE marked goods in EU, reference to harmonized standards, vigilance and incident reporting, Conformity Assessment Procedures, systems and procedure packs, Authorized Representative, consequences of wrongly affixed CE Marking, confidentiality, etc…

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.