MDD Definitions

Manufacturer

means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.

Notified body

A body approved by the competent authority to assess manufacturers' compliance with the MDD in accordance with its provisions. Such bodies are 'notified' to the European Commission and as such may operate anywhere within the EU. A notified body is established in one of the European Member States.
Click here for a list of notified bodies per European Directive.

Competent Authority

The body appointed by each national government within the EU to enforce compliance with the MDD, and handling vigilance reporting, in that country.
See http://www.farmatec.nl/hulpmiddelen/notificaties/klassei/default.aspx.

Conformity assessment

The process in order to assess whether a product conforms to European legislation. This can be carried out by the manufacturer or by a notified body.

Post Market Surveillance

A system established by the manufacturer to ensure that feedback from the marketplace provides early warning of quality problems. Post market surveillance must be a proactive activity for the manufacturer and goes beyond the assessment of complaints. 

Vigilance System

 A requirement whereby member states must ensure that any reports of adverse incidents involving medical devices in the marketplace, are recorded and evaluated centrally. Manufacturers must put in place procedures to respond to such reports, by evaluating the causes, reporting findings to competent authorities and taking the necessary corrective action. There is a guidance document (MEDDEV) issued which further details the requirements of the vigilance system. See MEDDEV 2.12/1 medical devices vigilance system ".