Amendment of regulation 2 of the principal Regulations2

In regulation 2 of the principal Regulations (interpretation), in paragraph (1)—

a

in the definition of “animal”, after “animal” insert—

  • for the purpose of regulations 13,17, 19A and 47

b

at the end of the definition of “authorised representative” insert—

  • with regard to the latter’s obligation under Directive 90/385, Directive 93/42 and Directive 98/79

c

after the definition of “the Community” insert—

  • “clinical data” means the safety or performance information that is generated from the use of a device, derived from—

    1. a

      clinical investigations of the device concerned; or

    2. b

      clinical investigations or other studies reported in scientific literature of a similar device for which equivalence to the device in question can be demonstrated; or

    3. c

      published or unpublished reports on other clinical experiences of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;

d

after the definition of “Directive 2005/50”, insert—

  • “Directive 2007/47” means Directive 2007/47/EC of the European Parliament and of the Council amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market5;

  • “Directive 2006/42/EC” means Directive 2006/42/EC of the European Parliament and of the Council on machinery6;

e

after the definition of “harmonised standard” insert—

  • “hazard” means a potential source of injury or damage to health;

f

for the definition of “intended for clinical investigation” substitute—

  • “intended for clinical investigation” means—

    1. a

      intended for use by a registered medical practitioner when conducting investigations of that device in an adequate human clinical environment; or

    2. b

      intended for use by any other person in a Member State who, by virtue of their professional qualification, is authorised to carry out investigations of that device in an adequate human clinical environment;

g

after the definition of “in vitro diagnostic medical device” insert—

  • “machinery” has the meaning given to it by Article 2(a) of Directive 2006/42;

h

in the definition of “medical device” for “an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application,” substitute “any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application,”; and

i

omit the definition of “medical specialist”.