Medical Device News EU – MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI

Thread starter Similar threads Forum Replies Date
T Implant Card - Article 18.1(a) and MDCG 2019-8 clarification EU Medical Device Regulations 3
M Informational EU – MDCG 2019-12 Designating authority’s final assessment form: Key Information Medical Device and FDA Regulations and Standards News 0
M Informational EU – MDCG 2019-6 v2 Questions and answers: Requirements relating to notified bodies Medical Device and FDA Regulations and Standards News 0
dgrainger Informational MDCG 2019-11: Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 0
M Informational MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies – August 2019 Medical Device and FDA Regulations and Standards News 0
M Informational EU – MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a “person re Medical Device and FDA Regulations and Standards News 7
M Informational EU – MDCG 2019-6 Questions and answers: Requirements relating to notified bodies Medical Device and FDA Regulations and Standards News 0
M Informational MDCG 2019-5 Registration of legacy devices in EUDAMED Medical Device and FDA Regulations and Standards News 11
M Informational MDCG 2019-4 Timelines for registration of device data elements in EUDAMED Medical Device and FDA Regulations and Standards News 0
M Informational MDCG 2019-3 Interpretation of Article 54(2)b – Pre- market clinical evaluation consultation procedure with the involvement of expert panels Medical Device and FDA Regulations and Standards News 0
M Informational EU – Schedule of meetings of MDCG and subgroups – 2019 Medical Device and FDA Regulations and Standards News 2
M Informational MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745/2017 Medical Device and FDA Regulations and Standards News 0
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 4
dgrainger Informational MDCG 2020:13 - Clinical evaluation assessment report template EU Medical Device Regulations 0
C MDCG 2020-06 Clinical evidence legacy devices EU Medical Device Regulations 3
rob73 MDCG guidance on class 1 devices and MDR EU Medical Device Regulations 0
M Informational EU – Ongoing Guidance development within MDCG Subgroups Medical Device and FDA Regulations and Standards News 1
M Informational EU – MDCG 2018-1 v2 Guidance on basic UDI-DI and changes to UDI-DI Medical Device and FDA Regulations and Standards News 0
M Informational EU – MDCG 2018-8 – Guidance on Content of the certificates, voluntary certificate transfers Medical Device and FDA Regulations and Standards News 0
M Medical Device News New MDCG endorsed documents EU Medical Device Regulations 5
M MDCG: industry is not part of and does not vote EU Medical Device Regulations 0
B Timeframe for updating QMS / transitioning from ISO 14971:2012 to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 10
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 5
J FMEA Handbook 2019 IATF 16949 - Automotive Quality Systems Standard 3
classical_quality Reflecting: Improvements Made 2019 & 2020? Coffee Break and Water Cooler Discussions 2
Aymaneh ISO 11607-1: 2019 main changes Other Medical Device Related Standards 2
K Overall residual risk according to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 5
M Gap analysis on ISO 14971:2019 with previous revision ISO 14971 - Medical Device Risk Management 4
B New ISO 14971:2019 Harm: unreasonable psychological stress, and cybersecurity ISO 14971 - Medical Device Risk Management 13
dgrainger Informational UK - Medicines and Medical Devices Bill 2019-21 UK Medical Device Regulations 0
Ajit Basrur Why is ISO 14644-3:2019 not approved by US? Other Medical Device Related Standards 1
Richard Regalado Top 10 operational risks of 2019 for business continuity planning Business Continuity & Resiliency Planning (BCRP) 6
A EN ISO 14971:2019 does not include the Annex Zs ISO 14971 - Medical Device Risk Management 4
J UK Medicines and Medical Devices Bill - 2019 ISO 13485:2016 - Medical Device Quality Management Systems 0
A ISO 10993-7:2008/ Amd.1:2019 - Classification of special populations Other Medical Device Related Standards 3
Ronen E Informational What's new in ISO 14971:2019 ISO 14971 - Medical Device Risk Management 2
T ISO 14971-2019 doubt - Evaluate if estimated risks are acceptable ISO 14971 - Medical Device Risk Management 9
Sidney Vianna IAQG News IAQG has a new website - December 2019 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
Y When will Notified Bodies require MedDev manufacturers to fully implement ISO 14971:2019? ISO 14971 - Medical Device Risk Management 1
Sidney Vianna Continual decline of ASQ - can it be saved? Nov 2019 ASQ - American Society for Quality 15
B Four Key Performance Indicators for Continual Improvement (Dec. 3 2019) [Deleted] Training - Internal, External, Online and Distance Learning 2
Richard Regalado ISO 22301:2019 has been published - Nov 2019 Business Continuity & Resiliency Planning (BCRP) 0
Marc Fiat Chrysler merges with PSA Group, owner of Peugeot and Citroën - Oct 2019 World News 0
M Informational ANVISA – CONSULTA PÚBLICA Nº 734, DE 22 DE OUTUBRO DE 2019 – Registro de dispositivos médicos para diagnóstico in vitro (in vitro diagnostic medical m Medical Device and FDA Regulations and Standards News 0
M Informational ANVISA – CONSULTA PÚBLICA No 730, DE 14 DE OUTUBRO DE 2019 – Registro de dispositivos médicos (Public consultation – registration of medical devices) Medical Device and FDA Regulations and Standards News 0
Marc From the "I'm glad I'm retired" Department (Oct 2019) Career and Occupation Discussions 7
M Informational EU – Minutes of the 24 July 2019 SCHEER Working Group on safety of breast implants in relation to anaplastic large cell lymphoma (BIA-ALCL) meeting Medical Device and FDA Regulations and Standards News 0
M Informational EU – Flyer – Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05) Medical Device and FDA Regulations and Standards News 0
Marc A 20 Hour Non-Stop Flight - (October 2019) Travel - Hotels, Motels, Planes and Trains 19
S World Quality Day 2019, November 14 - Build Quality Awareness in the organization ASQ - American Society for Quality 0

Similar threads

Top Bottom