PLACING MEDICAL DEVICES ON THE MARKET
To ensure that medical devices are placed on the market in the proper manner, the manufacturer has the following responsibilities:
Proper classification of the medical device.
The class of the product depends on its intended purpose. EU Directive 93/42/EEC provides that medical devices are grouped into four product classes: Class I (including devices in sterile condition or with a measuring function), Class IIa, Class IIb and Class III, depending on their complexity and on the potential risk to the patient, user or any third party.
Demonstration of compliance with the essential requirements of EU Directive 93/42/EEC.
In order to demonstrate that the device complies with the essential requirements of the directive, the manufacturer must provide adequate documentation (the Technical Documentation) describing the medical device and the processes used it its design, manufacture and placement on the market.
Attestation of conformity and CE marking of the medical device.
The attestation of the conformity of the medical device is made by the manufacturer when issuing the Declaration of Conformity.
For medical devices of any class above Class I and for certain products placed on the market in sterile condition and devices with a measuring function, prior to attesting to the conformity of the product, the manufacturer must initiate a conformity assessment procedure with the intervention of an independent third party, the Notified Body.
TECHNICAL DOCUMENTATION OF THE MEDICAL DEVICE
The Technical Documentation of the medical device consists of a set of documents drafted under the responsibility of the manufacturer, notwithstanding the partial or total outsourcing of resources at the design or production stage, to demonstrate the conformity of the medical device to the requirements of EU Directive 93/42/EEC, including the applicable Essential Requirements set out in its Appendix I.