Anwendungsbereich des Regulatory Essentials
Geltende Rechtsvorschriften:
Medicines and Medical Devices Act 2021
The UK MDR 2002 is the UK adaption of Directive 93/42/EEC on medical devices (EU MDD).
The new EU Medical Devices Regulation (Regulation 2017/745) (EU MDR) has applied in EU Member States and Northern Ireland.
As these EU regulations did not take effect during the transition period, they do not and will not apply in Great Britain.
IVD are regulated in part IV of the MDR 2002.
The UK MDR 2002, Regulation 2 defines an IVD as:
a medical device which
a) is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus,
equipment or system, whether used alone or in combination; and
b) is intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
i. concerning a physiological or pathological state
ii. concerning a congenital abnormality
iii. to determine the safety and compatibility of donations, including blood and tissue donations, with potential recipients, or
iv. to monitor therapeutic measures and includes a specimen receptacle but not a product for general laboratory use, unless that product, in view of its characteristics, is specifically intended by its manufacturer to be used for in vitro diagnostic examination.
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices - UK national transposition
Nationale Anwendungsebene:
UK (England, Scotland, Wales), Responsible Person, The Medical Devices Regulations 2002, UK Approved Body
Kommentar bezüglich der Vergleichbarkeit mit der EU-Gesetzgebung:
UK adopted to the former EU IVD Directive....