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).