Eudamed evaluation

Since 1 May 2011, the introduction of relevant information on medical devices into the European Eudamed database has become mandatory in all Member States of the European Union

Eudamed is a European database on medical devices which was established on the basis of the Commission Decision of 19 April 2010. (OJ L. Office of The EU L 2010 No 102 item 45). However, although the database has only been fully functioning recently, the European Commission has already carried out an evaluation of its functioning ('Evaluation of the 'EUropean DAtabank on MEdical Devices' of 11 October 2012, available on It must be stated that the mere carrying out of an analysis in this regard is closely linked to the amendments being prepared to the various directives relating to medical devices. The Commission based its assessment both on an analysis of the internal functioning of the database and on information provided to the relevant national authorities competent in the field of medical devices. As a result of the evaluation, the Commission identified specific structural problems in the operation of the Eudamed database and proposed certain amendments to it.

First of all, it was noted that the database does not provide a complete overview of either existing medical devices or relevant operators in this market. The Commission considers this to be mainly due to the fact that the current EU legislation applies only to the registration requirements for Class I products, while the establishment of a legal framework for products from the other classes has been left to national legislation. Addition, the current rules do not provide for sufficiently consistent rules on registration details, leading to situations where the scope of data available in different Member States is not uniform. The current system also provides for the input of relevant data by the competent national authorities, resulting in an unnecessary 'triangular transmission of data', in which they must first be transmitted by the manufacturer to the authority and only then by the authority to Eudamed. Another problematic issue is the current system of rules relating to the ownership of data in a database, since whoever enters any information into it immediately becomes the owner of it, which can lead to a re-application of that right. All these issues together mean that the European database does not guarantee a reliable and reliable overview of what actually exists on the market and that the individual data are not interconnected, which directly leads to clear weaknesses in the implementation of market surveillance of medical devices. Finally, the Commission also highlighted the lack of transparency of the information contained in Eudamed, due to the lack of any public access to it.

The fundamental amendment proposed by the Commission on the basis of the identified functional shortcomings of the Eudamed database is to allow the direct entry into the system of data by manufacturers of medical devices and other entities operating on that market in relation to registration data, as well as the direct entry of certificate data by notified bodies. Moreover, the information contained in the database would be partially accessible to everyone.

KONDRAT Law Firm and Partners

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