EUDAMED Database
April 27 2010
A new amending directive, 2007/47/EC, came into force on 21st March 2010, which amends the Medical Device Directive, 93/42/EEC. A new article has been added, Article 14a covering the requirements for a new European Database.
It states that 'Regulatory data in accordance with this directive shall be stored in a European database to the competent authorities to enable them to carry out their tasks relating to this directive on a well-informed basis'.
The databank shall contain the following:
- Data relating to registration of Manufacturers & Authorised Reps and their products
- Data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused
- Data obtained in accordance with the Vigilance proceedure
- Data relating to Clinical Investigations
The article also states that 'The provisions of this article shall be implemented no later than 5th September 2012'.
A Commission Desicion was published on 19th April 2010 'The European Databank on Medical Devices', which now enshrines the databank in European law.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:102:0045:0048:EN:PDF
The European Commission will make the use of the EUDAMED database mandatory for member states from 1st May 2011. It will take the form of web based portal and will be used as an exchange of information between national competent authorities and the Commission. It is currently being used on a voluntary basis by a number of EU countries.