Decree Amending The Decree On Medical Devices For In Vitro Diagnostic

Original Language Title: Decree amending the Decree on medical devices for in vitro diagnostic

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Decree amending the Decree on medical devices for in-vitro diagnostic section 1 In order No. 1269 of 12 December 2005 on medical devices, in vitro diagnostics, as amended by Executive Order No. 226 of 11 March 2011, is amended as follows 1. section 7 reads as follows: "§ 7th The notified body and the manufacturer or his representative, in agreement limits for completion of the assessment and verification referred two in Annex III-VII. PCS. 2. If one of this country notified body, the manufacturer did not meet the requirements of this Order, or that there should not be issued a certificate, limit, suspend or withdraw the notified body that issued the certificate, unless the manufacturer meets the requirements before the end of one of the Notified Body set time limit. PCS. 3. The notified body shall inform the Danish Medicines Agency of all issued, modified, supplemented, suspended and revoked certificates and the refusal of applications for certificates in accordance with the procedures in section 6. At the request of the Danish Medicines Agency makes the notified body any relevant additional information available. At the request of a notified body or from a competent authority in another Member State shall inform the notified body of the party requesting the certificates and of cases where the body has refused two issue a certificate, and the notified body shall provide all relevant information available. PCS. 4. Medicines Agency shall inform the European Commission and the other Member States in paragraphs. 2 and 3 decisions. ' section 2 of The order takes effect May 1, 2011 Ministry of Health, March 29, 2011 Bertel Haarder/Dorthe Søndergaard