|
IMDRF Standards Checklist modified in scope of COVID-19
Document date: Tue Mar 31 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Fri Apr 03 13:52:03 CEST 2020
|
|
State of play of joint assessments of Notified Bodies in the medical device sector
Document date: Tue Mar 17 00:00:00 CET 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Wed Mar 18 13:42:01 CET 2020
Redirected to: https://ec.europa.eu/health/sites/health/files/md_newregulations/docs/notifiedbodies_overview_en.pdf
|
|
MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
Document date: Mon Mar 16 00:00:00 CET 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Tue Mar 17 13:42:01 CET 2020
|
|
MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)
Document date: Mon Mar 16 00:00:00 CET 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Tue Mar 17 13:45:04 CET 2020
|
|
Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD
Document date: Sun Mar 15 00:00:00 CET 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Mon Mar 16 13:33:36 CET 2020
|
|
MDCG 2019-8 v2 - Guidance document - Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
Document date: Sun Mar 15 00:00:00 CET 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Tue Mar 17 07:42:30 CET 2020
|
|
MDCG 2018-1 v3 Guidance on BASIC UDI-DI and changes to UDI-DI
Document date: Sun Mar 15 00:00:00 CET 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Tue Mar 17 07:45:06 CET 2020
|
|
Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR)
Document date: Tue Mar 10 00:00:00 CET 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Fri Mar 13 12:16:30 CET 2020
|
|
NCARs statistics - 2019
Document date: Thu Jan 16 00:00:00 CET 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Fri Jan 17 12:58:02 CET 2020
|
|
The CND Nomenclature - background and general principles
Document date: Thu Jan 09 00:00:00 CET 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Fri Jan 10 14:52:01 CET 2020
|
|
The European Medical Device Nomenclature (EMDN) - the nomenclature of use in EUDAMED
Document date: Thu Jan 09 00:00:00 CET 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Fri Jan 10 14:56:04 CET 2020
|
|
MDCG 2019-16 - Guidance on Cybersecurity for medical devices
Document date: Mon Jan 06 00:00:00 CET 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Mon Jun 22 08:59:30 CEST 2020
|
|
MDCG 2019-15 GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES
Document date: Mon Dec 16 00:00:00 CET 2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: Tue Dec 17 17:20:40 CET 2019
|
|
MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation
Document date: Tue Dec 10 00:00:00 CET 2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: Wed Dec 11 15:49:37 CET 2019
|
|
MDCG 2019-14 Explanatory note on MDR codes
Document date: Tue Dec 10 00:00:00 CET 2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: Wed Dec 11 15:52:03 CET 2019
|
|
GS1 Basic UDI-DI
Document date: Tue Dec 03 00:00:00 CET 2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: Wed Dec 04 13:15:00 CET 2019
|
|
HIBCC Basic UDI-DI
Document date: Tue Dec 03 00:00:00 CET 2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: Wed Dec 04 13:17:02 CET 2019
|
|
ICCBBA UDI HRI & AIDC Formats
Document date: Tue Dec 03 00:00:00 CET 2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: Wed Dec 04 13:09:05 CET 2019
|
|
HIBCC UDI HRI & AIDC Formats
Document date: Tue Dec 03 00:00:00 CET 2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: Wed Dec 04 13:16:03 CET 2019
|
|
ICCBBA Basic UDI-DI
Document date: Tue Dec 03 00:00:00 CET 2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: Wed Dec 04 13:10:31 CET 2019
|
|
IFA Basic UDI-DI
Document date: Tue Dec 03 00:00:00 CET 2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: Wed Dec 04 13:13:01 CET 2019
|
|
IFA UDI HRI & AIDC Formats
Document date: Tue Dec 03 00:00:00 CET 2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: Thu Dec 05 10:19:00 CET 2019
|
|
GS1 UDI HRI & AIDC Formats
Document date: Tue Dec 03 00:00:00 CET 2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: Thu Dec 05 10:20:41 CET 2019
|
|
Flyer - Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
Document date: Thu Oct 17 00:00:00 CEST 2019
- Created by GROW.DDG1.D.4
- Publication date: n/a
- Last update: Thu Nov 07 10:18:41 CET 2019
|
|
Designating authority's final assessment form: Key Information (EN)
Document date: Wed Oct 16 00:00:00 CEST 2019
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Wed Jun 10 14:13:01 CEST 2020
|
