Article 1 Definitions

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

1. (a)

   ‘device’ means active implantable medical devices as defined in F1regulation 2(1) of the Medical Devices Regulations 2002;

2. (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^f1;

3. (c)

   F2“approved body” has the same meaning as in regulation 2(1) of the Medical Devices Regulations 2002;

4. (d)

   F3“accreditation” means an attestation by a national accreditation body conveying formal recognition that a conformity assessment body is competent to carry out a specific activity;

5. (e)

   F4...

6. (f)

   F5...

7. (g)

   ‘on-site assessment’ means a verification in the premises of the body or of one of its subcontractors or subsidiaries by the F6Secretary of State;

8. (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;

9. (i)

   ‘observed audit’ means F7the Secretary of State’s assessment of the performance of a notified body’s audit team in the premises of the body's client;

10. (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;

11. (k)

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

    1. (i)

       a legal person;

    2. (ii)

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

    3. (iii)

       several natural or legal persons who jointly perform these tasks.