Directorate General Health & Consumers
What process does a Medical Device have to follow to be placed on the market?
Any medical device placed on the European market must comply with the relevant legislation, notably with Directive 93/42/EEC, or with the active implantable devices Directive 90/385/EEC or with the in vitro devices Directive 98/79/EC. You first need to determine whether the devices you intend to manufacture or import falls under any of these Directives (see here for guidance of definition of medical device).
All medical devices must fulfil the essential requirements set out in the above mentioned Directives. Where available, relevant standards may be used to demonstrate compliance with the essential requirements defined in the Directives (see the of list of harmonized standards).
Manufacturers also need to determine the appropriate conformity assessment route. For devices falling under Directive 93/42/EEC other than custom-made devices and devices intended for clinical investigation, the conformity assessment route depends on the class of the device, to be determined in accordance with certain rules, see Articles 9 and 11 thereof. The classification is to be done in accordance with Annex XI to this Directive. For details, see the guidance on classification. In the case of in vitro diagnostic devices, the appropriate conformity assessment route is determined by lists, see Article 9 paragraph 2 and 3 of Directive 98/79/EC and Annex II thereto. The appropriate conformity assessment route for active implantable medical devices is determined without reference to classes or lists, see Article 9 of Directive 90/385/EEC.
Once the applicable class or list has been determined, manufacturers will need to follow the appropriate conformity assessment procedure (see our guidance on conformity assessment). Subject to the type of the device, this may require them to have their quality systems and technical documentation reviewed by a Notified Body before they can place their products on the market (see our list of Notified Bodies). The Notified Body will need to assure itself that relevant requirements have been met before issuing relevant certification. Manufacturers can then place the CE marking on their products to demonstrate compliance with the requirements.
To be CE marked, devices might also have to fulfil the requirements of other directives, see e.g. Article 4 paragraph 5 of Directive 93/42/EEC (relevant directives can be found on this webpage). See also our interpretative documents on the applicability of the Machinery Directive and of the Personal Equipment Directive.
If a medical device is correctly CE marked (= CE marked in due form and subsequent to the correct application of the respective conformity assessment procedure), it does not need any additional approval or certification to be marketed in the entire European Union (EU), in the European Economic Area (EEA) and in Switzerland. The CE marking allows free movement of goods in these states. However, these states can lawfully request that the medical devices are registered. Furthermore, states may have requirements in place in relation to the language of the device information. We therefore recommend contacting the respective national authorities.