Eudamed is a European database on medical devices, which was established at the level of European Union legislation by commission decision of 19 April 2010. (OJ L. Office of The EU L 2010 No 102 item 45). The Decision constituted the implementation of the objectives of a compatible database system, which was provided for respectively in Article 13(1) of regulation (EC) No 1257/1999. Whereas Article 10b (1) of Regulation (EEC) No 245 Whereas article 3 of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active-deposition medical devices ( Whereas Article 14a (1) of Regulation (EEC) No 245 Whereas article 3 of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices and Article 10 (2) of Directive 91/42/EEC should be replaced by the following: Whereas Article 12 (1) of Regulation (EEC) No 2 In accordance with Article 3 of Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on medical devices used for in vitro diagnosis,
The primary objective of setting up this database was to strengthen market surveillance by ensuring rapid access by competent authorities to information on manufacturers and authorised representatives, devices and certificates, the exchange of data on clinical trials, and to contribute to the uniform application of those Directives, in particular as regards registration requirements.
The detailed scope of the data to be entered in the Eudamed database is set out in the above Directives respectively, in particular data on the registration of manufacturers and devices, data on certificates issued, renewed, amended, supplemented, suspended, withdrawn or refused, data obtained in accordance with the observation procedure and data on clinical trials.
Individual data may be entered online or by sending XML files in all official languages of the Community, with the use of internationally recognised names and an appropriate numerical code to facilitate the search for the products needed.
The manner and form in which the data are entered into the Eudamed database is indicated in the Annex to this Commission Decision, specifying in particular the minimum set of data required for inclusion in the database in the context of each of the above directives, relating inter alia to the data of the manufacturer/authorised representative of the medical device, the device certificate or the report of the competent national authority in connection with the occurrence of a medical incident.
Before 1 May 2011, EU Member States were able to use Eudamed on a voluntary basis, but after that date the introduction of relevant information into the database had already become mandatory. Moreover, by 30 April 2012, the database also had to enter data existing before 1 May 2011, although only to the narrower extent specified in the Commission decision.
Importantly, the decision in question was addressed only to the EU Member States and, as such, did not impose any new obligations directly on medical device operators, since those obligations stem rather from the directives referred to at the outset, which were previously implemented into the Polish legal order by the Law of 10 May 2010 on medical devices. On the other hand, the entry into force of the Decision also resulted in the entry into force of regulations conferring the power to transfer certain data to Eudamed, the President of the Office for registration of medicinal products, medical devices and biocidal products, which created an additional instrument aimed at the comprehensive and effective application of measures for the supervision of the market in medical devices.