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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Publication of amending medical devices for in vitro diagnostics

§ 1

Notice no. 1269 of 12. December 2005 on medical devices for in vitro diagnostics, as amended by Notice No 226 of 11. March 2011, the following changes are made :

1. § 7 ITREAS :

" § 7 The notified body and the manufacturer or his authorized representative shall lay down the deadlines for the implementation of the assessments and checks provided for in Annex III-VII.

Paragraph 2. Where a person in this country has notified body that the manufacturer does not comply with the requirements of this notice or that a certificate should not be issued, limits, suspending or recalling the notified body of the certificate issued, unless the manufacturer complies with the requirements prior to the expiry of any of the notified body ' s time limit.

Paragraph 3. The notified body must notify the Medicinal Products Agency for all issued, amended, extended, suspended and revoked certificates as well as on informed discharges of applications for certificates in accordance with the procedures in section 6. At the request of the Evaluation of Medicinal Products, the notified body must provide all additional relevant information. Upon request by a competent body or by a competent authority of another Member State, the notified body must inform the requesting party of the certificates issued and, where the notified body has refused to issue a certificate ; the certificate, like the notified body, makes all relevant information available.

Paragraph 4. The governing board shall inform the Commission and the other Member States of the measures referred to in paragraph 1. The decisions of 2 and 3. ` ;

§ 2

The announcement shall enter into force on 1. May 2011

Homeland and Homeland Security, the 29th. March, 2011

Bertel Haarder

-Dorthe Søndergaard