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Unique Device Identification (UDI) System - FAQs
Document date: Sun Aug 09 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Mon Aug 10 12:26:00 CEST 2020
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Conformity assessment procedures for protective equipment
Document date: Thu Jul 09 00:00:00 CEST 2020
- Created by GROW.DDG1.C.4
- Publication date: n/a
- Last update: Mon Jul 13 13:51:34 CEST 2020
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Declaration of interest (DOI) form - Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
Document date: Sun Jul 05 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Tue Jul 07 13:38:09 CEST 2020
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Manufacturer incident report 2020
Document date: Thu Jun 11 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Fri Jun 12 14:54:10 CEST 2020
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Manufacturer incident report for importing XML file with Adobe Professional 2020
Document date: Thu Jun 11 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Fri Jun 12 14:54:42 CEST 2020
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MDCG 2020-12 Transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product [...] as well as on devices manufactured using TSE susceptible animal tissues
Document date: Tue Jun 09 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Wed Jun 10 14:20:09 CEST 2020
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MDR and IVDR implementing measures rolling plan
Document date: Tue Jun 02 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Wed Jun 03 14:35:39 CEST 2020
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Planned meetings of Medical Device Coordination Group (MDCG) and subgroups in 2020
Document date: Thu May 28 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Tue Jun 02 07:10:32 CEST 2020
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MDCG 2020-11 Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulatio
Document date: Wed May 27 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Thu May 28 07:11:03 CEST 2020
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Amendment to Implementing Regulation 920/2013 on the designation of notified bodies
Document date: Mon May 25 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Tue May 26 11:10:31 CEST 2020
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Questions and Answers document regarding the Implementation of the new Manufacturer Incident Report (MIR) Form
Document date: Mon May 18 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Tue May 19 19:11:30 CEST 2020
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Commission Guidelines on Union-wide derogations for medical devices
Document date: Mon May 18 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Tue Sep 15 09:31:12 CEST 2020
Redirected to: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_com_derogations_en.pdf
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How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used – also in the COVID-19 context
Document date: Sun May 17 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Mon May 25 14:47:30 CEST 2020
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Changelog file 2020
Document date: Thu May 14 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Fri May 15 10:18:02 CEST 2020
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MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745
Document date: Tue May 12 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Fri May 15 10:30:34 CEST 2020
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Privacy statement - Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
Document date: Thu Apr 23 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Fri Apr 24 14:13:33 CEST 2020
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MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories
Document date: Thu Apr 23 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Mon Apr 27 06:57:32 CEST 2020
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MDCG 2020-5 Clinical Evaluation - Equivalence. A guide for manufacturers and notified bodies
Document date: Wed Apr 22 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Fri Apr 24 07:29:33 CEST 2020
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MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies
Document date: Wed Apr 22 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Fri Apr 24 07:33:41 CEST 2020
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MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies
Document date: Wed Apr 22 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Fri Apr 24 07:36:39 CEST 2020
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MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies
Document date: Wed Apr 22 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Fri Apr 24 07:38:42 CEST 2020
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Current performance of COVID-19 test methods and devices and proposed performance criteria - Working document of Commission services
Document date: Wed Apr 15 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Fri Apr 17 11:42:01 CEST 2020
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Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions
Document date: Tue Apr 07 00:00:00 CEST 2020
- Created by GROW.DDG1.D.DIR
- Publication date: n/a
- Last update: Wed Apr 08 12:25:03 CEST 2020
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MDCG 2019-3 Interpretation of Article 54(2)b rev 1
Document date: Sun Apr 05 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Tue Apr 07 07:55:33 CEST 2020
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Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context
Document date: Thu Apr 02 00:00:00 CEST 2020
- Created by GROW.R.2.DIR
- Publication date: n/a
- Last update: Fri Apr 03 14:04:05 CEST 2020
Redirected to: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_guidance-active-implantable_en.pdf
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