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Questions and answers

Questions and answers

Does a European database for Medical Devices exist?

EUDAMED is the European databank for medical devices. It has been established under the Medical Device Directives and is a secure web-based portal acting as a central repository for information exchange between national competent Authorities and the Commission.

Depending on the applicable directive, EUDAMED contains data on: registration of manufacturers, authorised representatives and devices, data relating to certificates, data obtained in accordance with the vigilance procedure and data on clinical investigations.

Access is restricted to the Medical Devices National Competent Authorities

Is my product a medical device?

Defining a given product as a medical device and interpretation of the classification rules fall within the competence of the National Competent Authorities where the product is on the market. This should be done on a case-by-case basis, taking account of all the characteristics of the product.

What is a borderline product?

Borderline products are considered to be those where it is not clear whether a given product is a medical device, an in vitro diagnostic medical device, an active implantable medical device or not.

Or alternatively, borderline cases are those cases where the product falls within the definition of a medical device but is excluded from the scope of the relevant Directives.

Where can I find guidance and examples on borderline products / medical devices / medicinal products?

Practical guidance and illustrative examples can be found in the MEDDEV 2.1/3 and in the Manual on borderline and classification in the Community Regulatory framework for medical device (283 KB)

Where can I find information about harmonised standards under the Medical devices directives?

The medical devices directives do not contain technical details but broad safety requirements, so-called 'essential' requirements. One of the best ways for manufacturers to translate these 'essential' requirements into technical solutions is to use specifically developed European standards. These standards are called harmonised standards and give a 'presumption of conformity' with the directive for which they have been developed. The European Commission services do not take part in the development of the harmonised standards. They publish the lists transmitted by the relevant standardisation bodies in the Official Journal of the European Union.

The list of published harmonised standards is available at the standardisation website. The standards themselves have to be bought. For more detailed information please consult the European Committee for standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) and the CEN monthly snapshot on Healthcare.

Which process does a medical device have to follow to be placed on the market?

To be placed on the market, a medical device needs to be correctly CE marked. The only exceptions to this rule are custom-made devices or devices intended for clinical investigation. To affix the CE mark, the device has to be in conformity with the general requirements contained in the first Annex of the three directives on medical devices, the so-called essential requirements.

To be CE marked, devices might also have to fulfill the requirements of other directives, see e.g. Article 4 paragraph 5 of Directive 93/42/EEC.

For medical devices of higher risks, a Notified Body must have been involved prior to the CE marking; see e.g. Articles 9 and 11 of Directive 93/42/EEC.

  • More information:
    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, 18 kB).
     
    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 (21 kB) and of the Personal Equipment Directive (28 kB).

    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.

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