Article 1U.K.Definitions

For the purposes of this Regulation, the following definitions shall apply:

(a)

‘device’ means active implantable medical devices as defined in Article 1(2)(c) of Directive 90/385/EEC or medical devices and their accessories as defined in Article 1(2) of Directive 93/42/EEC;

(b)

‘conformity assessment body’ means a body which performs calibration, testing, certification and inspection activities under Article R1(13) in Annex I to Decision No 768/2008/EC of the European Parliament and of the Council(1);

(c)

‘notified body’ means a conformity assessment body which has been notified by a Member State in accordance with Article 11 of Directive 90/385/EEC or Article 16 of Directive 93/42/EEC;

(d)

‘accreditation body’ means the sole body in a Member State that performs accreditation with authority derived from the State as laid down by Article 2(10) of Regulation (EC) No 765/2008;

(e)

‘designating authority’ means the authority(ies) entrusted by a Member State to assess, designate, notify and monitor notified bodies under Directive 90/385/EEC or Directive 93/42/EEC;

(f)

‘competent authority’ means the authority(ies) in charge of market surveillance and/or of vigilance for devices;

(g)

‘on-site assessment’ means a verification in the premises of the body or of one of its subcontractors or subsidiaries by the designating authority;

(h)

‘surveillance on-site assessment’ means a periodic routine on-site assessment which is neither the on-site assessment undertaken for the initial designation, nor the on-site assessment undertaken for the renewal of the designation;

(i)

‘observed audit’ means a designating authority's assessment of the performance of a notified body’s audit team in the premises of the body's client;

(j)

‘functions’ means the tasks to be fulfilled by the body’s staff and its external experts, namely: auditing of the quality systems, product related technical documentation review, review of clinical evaluations and investigations, device testing and, for each of the previously mentioned items, the final review and decision making thereon;

(k)

‘subcontracting’ means the transfer of tasks to one of the following:

(i)

a legal person;

(ii)

a natural person who further delegates these tasks or parts thereof;

(iii)

several natural or legal persons who jointly perform these tasks.