Europe's new device regulations fail to protect the public Commercial interests and lack of transparency remain key weaknesses

被引:12
作者
Allan, Chris [1 ]
Joyce, Thomas J. [2 ]
Pollock, Allyson M. [1 ]
机构
[1] Newcastle Univ, Inst Hlth & Soc, Newcastle Upon Tyne, Tyne & Wear, England
[2] Newcastle Univ, Sch Engn, Newcastle Upon Tyne, Tyne & Wear, England
来源
BMJ-BRITISH MEDICAL JOURNAL | 2018年 / 363卷
关键词
D O I
10.1136/bmj.k4205
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
引用
收藏
页数:2
相关论文
共 13 条
[1]   How can we get high quality routine data to monitor the safety of devices and procedures? [J].
Campbell, Bruce ;
Stainthorpe, Andrew C. ;
Longson, Carole M. .
BMJ-BRITISH MEDICAL JOURNAL, 2013, 346
[2]   MEDICAL DEVICES Out of joint: The story of the ASR [J].
Cohen, Deborah .
BRITISH MEDICAL JOURNAL, 2011, 342
[3]   Commentary: Europe needs a central, transparent, and evidence based regulation process for devices [J].
Eikermann, Michaela ;
Gluud, Christian ;
Perleth, Matthias ;
Wild, Claudia ;
Sauerland, Stefan ;
Gutierrez-Ibarluzea, Inaki ;
Antoine, Sunya-Lee ;
Demotes-Mainard, Jacques ;
Neugebauer, Edmund A. M. .
BMJ-BRITISH MEDICAL JOURNAL, 2013, 346
[4]  
European Commission, 2018, ACT PLAN IMM ACT EX
[5]  
European Commission, 2018, MED DEV
[6]  
European Databank on Medical Devices, 2012, EV EUR DAT MED DEV
[7]  
European Patent Office, EUR PAT APPL FILED E
[8]   The need for transparency of clinical evidence for medical devices in Europe [J].
Fraser, Alan G. ;
Butchart, Eric G. ;
Szymanski, Piotr ;
Caiani, Enrico G. ;
Crosby, Scott ;
Kearney, Peter ;
Van de Werf, Frans .
LANCET, 2018, 392 (10146) :521-530
[9]   How mesh became a four letter word [J].
Gornall, Jonathan .
BMJ-BRITISH MEDICAL JOURNAL, 2018, 363
[10]   Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process [J].
Heneghan, Carl J. ;
Goldacre, Ben ;
Onakpoya, Igho ;
Aronson, Jeffrey K. ;
Jefferson, Tom ;
Pluddemann, Annette ;
Mahtani, Kamal R. .
BMJ OPEN, 2017, 7 (12)