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Standards [CURRENT]

BS EN ISO 11980

Ophthalmic optics. Contact lenses and contact lens care products. Guidance for clinical investigations
Edition 2012-12-31

Standards [CURRENT]

BS EN ISO 13972

Health informatics. Clinical information models. Characteristics, structures and requirements
Edition 2022-04-26

Standards [CURRENT]

BS EN ISO 14155

Clinical investigation of medical devices for human subjects. Good clinical practice
Edition 2020-08-19

Standards [CURRENT]

BS EN ISO 20916

In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice
Edition 2019-06-06

Standards [CURRENT]

BS EN ISO 81060-2+A2

Non-invasive sphygmomanometers. Part 2: Clinical investigation of intermittent automated measurement type
Edition 2019-12-09

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

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

EUV 536/2014

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
Edition 2014-04-16

Corrigendum to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
Edition 2016-11-17

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