Commission Directive 2011/100/EU of 20 December 2011 amending Directive 98/79/EC of the European Parliament and of the Council on in-vitro diagnostic medical devices
Having regard to the Treaty on
the Functioning of the European Union,
Having regard to Directive
98/79/EC of the European Parliament and of the Council of 27 October 1998 on
in- vitro diagnostic medical devices (1 ), and in particular Article 14 thereof,
Whereas:
(1) In accordance with Article 14(1)(a) of Directive 98/79/EC, the United
Kingdom has requested that the Commission take the necessary measures to add
‘Variant Creutzfeldt-Jakob disease’ (vCJD) assays to List A of Annex II to that
Directive.
(2) In order to ensure the highest level of health protection and ensure
that the conformity of vCJD assays with the essential requirements set out in
Annex I to Directive 98/79/EC is verified by notified bodies, vCJD assays for
blood screening, diagnosis and confirmation should be added to List A of Annex
II to Directive 98/79/EC.
(3) The measures provided for in this Directive are in accordance with the
opinion of the Committee set up by Article 6(2) of Council Directive 90/385/EEC
( 2 ) and referred to in
Article 7(1) of Directive 98/79/EC,
Για να κατεβάσετε το πλήρες κείμενο της Οδηγίας
πατήστε στον παρακάτω σύνδεσμο…
Φαρμακευτικο Μαρκετινγκ: Θεωρια, Πρακτικη, Δεοντολογια
The ultimate guide for Pharma Marketing
Champions
Ζητήστε
το στα κεντρικά βιβλιοπωλεία ή δώστε την παραγγελία σας τώρα…