section 1 the Agency shall apply the administrative

procedures referred to in



1. Council Directive 90/385/EEC of 20 June 1990 on the

approximation of the laws of the Member States relating to Active

implantable medical devices, and



2. Council Directive 93/42/EEC of 14 June 1993 concerning

medical devices



as last amended by European Parliament and Council

Directive 2007/47/EC of 5 september 2007 amending

Council Directive 90/385/EEC on the approximation of the laws of the

Member States relating to active medical device

medical devices, Council Directive 93/42/EEC on

medical devices and Directive 98/8/EC concerning the

the placing of biocidal products on the market, as well as



3. European Parliament and Council Directive 98/79/EC of the

of 27 October 1998 on in vitro medical devices

Diagnostics.



In the procedure, it shall inter alia: included to provide data that

The FDA obtained under their supervision of

medical devices to the authorities of other States

in the European economic area, Switzerland and

to the European Commission, as well as to register some of

the data in the specified database by the Commission.

Regulation (2010:1383).