NLMedicalDevices object

Transposition of EU Directives on MD

1. The Medical Devices Regulations 2002
2. The Medical Devices (Amendment) Regulations 2012 have been published and came into force on 1 July 2012.
These Regulations have the principal purpose of amending the Medical Devices Regulations 2002 to implement Directive 2011/100/EU such that variant Creutzfeldt-Jakob disease (vCJD) assays for blood screening, diagnosis and confirmation are added to List A of Annex II of Directive 98/79/EC on in-vitro diagnostic medical devices. The Regulations also make some other minor changes to the Medical Devices Regulations 2002, but these do not have any practical effect.

In addition to the UK regulations, internationally accepted documents and guidelines e.g. the Declaration of Helsinki and ISO 1415:2011 should be adhered to in order to guarantee a high standard of quality.
(please note: Version 1996 of Decl.of Helsinki is most in line with UK regulations)

ISO 14155 is a European standard which regulates the organisation, documentation etc. of clinical trials for medical devices. This document is available for a fee via the ISO-website (ISO 14155:2011).