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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 devicepdf(346 kB) Choose translations of the previous link 

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 fulfil 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.