MEDICAL DEVICE REGULATIONS IN THE NEW EUROPE

被引:1
|
作者
HIGSON, GR
机构
[1] Medical Technology Consultants Europe Ltd., Egham, Surrey TW20 9HNUK, Arndale House, The Precinct
关键词
D O I
10.3109/03091909209021971
中图分类号
R318 [生物医学工程];
学科分类号
0831 ;
摘要
We are now in 1992, the year of the 'Completion of the Internal Market'. Big changes in the ways in which medical devices will be controlled in Europe are on the way, but many healthcare professionals are unaware of these changes and what they will mean to them. This article explains the moves that are now under way to harmonize medical device legislation throughout Europe and the many features, new to the UK, that they will introduce.
引用
收藏
页码:107 / 111
页数:5
相关论文
共 50 条
  • [1] A Comparative Study of Medical Device Regulations: US, Europe, Canada, and Taiwan
    Chen, Yi-Jung
    Chiou, Chi-Ming
    Huang, Yu-Wen
    Tu, Pei-Weng
    Lee, Yung-Chuan
    Chien, Chia-Hung
    [J]. THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2018, 52 (01) : 62 - 69
  • [2] A Comparative Study of Medical Device Regulations: US, Europe, Canada, and Taiwan
    Yi-Jung Chen
    Chi-Ming Chiou
    Yu-Wen Huang
    Pei-Weng Tu
    Yung-Chuan Lee
    Chia-Hung Chien
    [J]. Therapeutic Innovation & Regulatory Science, 2018, 52 : 62 - 69
  • [3] New regulations on medical devices in Europe: what to expect?
    Fouretier, Alice
    Bertram, Delphine
    [J]. EXPERT REVIEW OF MEDICAL DEVICES, 2014, 11 (04) : 351 - 359
  • [4] New Regulations on Medical Devices in Europe: Are They an Opportunity for Growth?
    Maresova, Petra
    Hajek, Ladislav
    Krejcar, Ondrej
    Storek, Michael
    Kuca, Kamil
    [J]. ADMINISTRATIVE SCIENCES, 2020, 10 (01)
  • [5] New medical device regulations: the regulator's view
    Melvin, Tom
    Torre, Marina
    [J]. EFORT OPEN REVIEWS, 2019, 4 (06): : 351 - 356
  • [6] Regulations for the prescription of footwear as medical device
    Petcu, Daniel
    Roşculeţ, Viorica
    [J]. Leather and Footwear Journal, 2017, 17 (01): : 59 - 66
  • [7] Medical Device Regulations: A Current Perspective
    Gupta, Sandeep Kumar
    [J]. JOURNAL OF YOUNG PHARMACISTS, 2016, 8 (01) : 6 - 11
  • [8] Artificial Intelligence, data protection and medical device regulations: squaring the circle with a historical perspective in Europe
    Pecchia, Leandro
    Maccaro, A.
    Matarrese, M. A. G.
    Folkvord, F.
    Fico, G.
    [J]. HEALTH AND TECHNOLOGY, 2024, 14 (04) : 663 - 670
  • [9] New Medical Device Regulations ahead - What does that mean for Arthroplasty Registers?
    Labek, Gerold
    Schoeffl, Harald
    Meglic, Matic
    [J]. ACTA ORTHOPAEDICA, 2015, 86 (01) : 5 - 6
  • [10] On the universality of medical device regulations: the case of Benin
    Maccaro, A.
    Piaggio, D.
    Leesurakarn, S.
    Husen, N.
    Sekalala, S.
    Rai, S.
    Pecchia, L.
    [J]. BMC HEALTH SERVICES RESEARCH, 2022, 22 (01)