Betekenis van:
medical procedure

Voorbeeldzinnen

1. Endoscopy is a medical procedure that uses an endoscope.
2. Notwithstanding the third subparagraph, in the case of a leisure pilot licence a general medical practitioner who has sufficient detailed knowledge of the applicant's medical background may, if so permitted under national law, act as an aero-medical examiner, in accordance with detailed implementing rules adopted pursuant to the procedure referred to in Article 65(3); these implementing rules shall ensure that the level of safety is maintained.
3. Hip, knee and shoulder total joint replacements already certified following the procedure relating to the EC type examination set out in Annex III to Directive 93/42/EEC, coupled with the procedure relating to the EC verification set out in Annex IV or the procedure relating to the EC declaration of conformity set out in Annex V to that Directive, are not affected by the present Directive as these certification schemes are the same for both class IIb and class III medical devices.
4. For Switzerland, the official batch release procedure is specified in Article 17 of the Federal Law on medicinal products and medical devices and in Articles 18–21 of the Ordinance of the Swiss Agency for Therapeutic Products on the requirements for the marketing authorisation of medicinal products.
5. Records must demonstrate that before tissues and cells are released all appropriate specifications are met, in particular all current declaration forms, relevant medical records, processing records and test results have been verified according to a written procedure by a person authorised for this task by the responsible person as specified in Article 17 of Directive 2004/23/EC.
6. Hip, knee and shoulder replacements that have been subject to a conformity assessment procedure pursuant to Article 11(3)(b)(iii) of Directive 93/42/EEC before 1 September 2007 may be subject to a conformity assessment as class III medical devices pursuant to Article 11(1)(b)(i) or (ii) before 1 September 2010.
7. The inclusion in Annex V, point 5.1.3 of new medical specialties common to at least two fifths of the Member States may be decided on in accordance with the procedure referred to in Article 58(2) with a view to updating this Directive in the light of changes in national legislation.
8. In the light of technical or scientific progress, the Commission may adopt, in accordance with the procedure referred to in Article 17(2), amendments to the ratings in Article 6, the rating endorsements in Article 7, the provisions on medical certificates in Article 12(3) and the Annexes.
9. Hip, knee and shoulder replacements that have been subject to a conformity assessment procedure pursuant to Article 11(3)(b)(iii) of Directive 93/42/EEC before 1 September 2007 may be subject to a conformity assessment as class III medical devices pursuant to Article 11(1)(b)(i) or (ii) before 1 September 2010. This provision does not preclude a manufacturer from submitting an application for conformity assessment based on Article 11(1)(a) of Directive 93/42/EEC.
10. ‘By 16 January 2009, the European Aviation Safety Agency should complete a scientific and medical evaluation of Subpart Q and, where relevant, of Subpart O of Annex III. On the basis of the results of this evaluation, and in accordance with the procedure referred to in Article 12(2), the Commission should, if necessary, draw up and submit proposals without delay to amend the relevant technical provisions.