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Verordnung zur Anpassung der DIMDI-Arzneimittelverordnung Verordnung, der Verordnung über klinische Prüfungen von Medizinprodukten und der Bundespflegesatzverordnung an die gesetzliche Aufgabenübertragung vom Deutschen Institut für Medizinische Dokumentation und Information auf das Bundesinstitut für Arzneimittel und Medizinprodukte und zur weiteren Änderung der Bundespflegesatzverordnung
Edition 2020-07-13

Administrative provision

MedGVKlinErprobAusnRL

Guideline for the approval of exceptions according to § 5 clause 10  MedGV for the clinical testing of medical-technical instruments
Edition 1986-11-10

Regulation

EGV 847/2000

Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts similar medicinal product and clinical superiority
Edition 2000-04-27

Regulation

EGV 1950/2006

Commission Regulation (EC) No 1950/2006 of 13 December 2006 establishing, in accordance with Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, a list of substances essential for the treatment of equidae and of substances bringing added clinical benefit
Edition 2006-12-13

Regulation

EGV 668/2009

Commission Regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises
Edition 2009-07-24

Standards [CURRENT]

DIN EN ISO 80601-2-56

Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017 + Amd1:2018); German version EN ISO 80601-2-56:2017 + A1:2020
Edition 2020-08

Standards [CURRENT]

DIN 6875-1

Special radiotherapy equipments - Part 1: Percutaneous stereotactic radiotherapy, basic performance characteristics and essential test methods
Edition 2004-01

Standards [CURRENT]

DIN 6875-2

Special radiotherapy equipment - Part 2: Percutaneous stereotactic radiotherapy - Constancy testing
Edition 2008-11

Draft standard

DIN EN 16372

Aesthetic surgery and aesthetic non-surgical medical services; German version prEN 16372:2013
Edition 2013-05

Standards [CURRENT]

DIN EN ISO 11979-8

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017); German version EN ISO 11979-8:2017
Edition 2017-08

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