European Medical Device Directive: impact on nuclear medicine.
The European Council Directive 93/42/EEC concerning medical devices (14 June 1993) assigns new responsibilities and imposes technical requirements both to the manufacturer and user of medical devices. In this paper the general outlines of the directive are discussed with a particular emphasis on the risk classification of products, the compliance and evaluation process and the CE-marking regulations. Furthermore, some practical implications are highlighted for devices and tools relevant to the field of nuclear medicine such as radiation detectors, gamma- and PET-cameras and software.
Kuyvenhoven
J D
JD
Department of Nuclear Medicine, University Medical Center, Utrecht, The Netherlands.
Lahorte
P
P
Persyn
K
K
De Geest
E
E
van Loon
P W
PW
Jacobs
F
F
van Rijk
P P
PP
Lemahieu
I
I
Dierckx
R A
RA
D015502:Absorptiometry, Photon / Q000592:standards; D003626:Data Display / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D005062:European Union; D015902:Gamma Cameras / Q000592:standards; D019983:Guideline Adherence / Q000331:legislation & jurisprudence; D006801:Humans; D009683:Nuclear Medicine / Q000331:legislation & jurisprudence* / Q000592:standards*; D011874:Radiometry / Q000592:standards; D018570:Risk Assessment; D012308:Risk Management / Q000331:legislation & jurisprudence / Q000592:standards; D012986:Software Validation; D014055:Tomography, Emission-Computed / Q000295:instrumentation / Q000592:standards