Informational EU – MDCG 2018-1 v2 Guidance on basic UDI-DI and changes to UDI-DI

Thread starter Similar threads Forum Replies Date
M Informational EU – MDCG 2018-8 – Guidance on Content of the certificates, voluntary certificate transfers 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
T Implant Card - Article 18.1(a) and MDCG 2019-8 clarification 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 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
M Medical Device News EU – MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI 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
K Comparison wanted: ISO 15378:2018 vs. PS9000:2016 Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
John C. Abnet ISO 45001:2018 (5.4 - Consultation and participation of workers) Occupational Health & Safety Management Standards 10
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4
A ISO 10002:2018 Checklist Needed (Complaints Handling) Customer Complaints 5
M Informational RoHS Standard - EN 63000:2018 to replace EN 50581:2012 Medical Device and FDA Regulations and Standards News 11
A ISO 41001:2018 - Clause No.8 Operations Part Quality Management System (QMS) Manuals 2
S Starting an ISO 41001:2018 Facility management system Other ISO and International Standards and European Regulations 3
Richard Regalado What could go wrong with information: Ransomware statistics and facts (2018 to present) IEC 27001 - Information Security Management Systems (ISMS) 0
I ISO 22000:2018 - Operational Prerequisite Program Examples Food Safety - ISO 22000, HACCP (21 CFR 120) 2
Watchcat DE NOVO SUMMARY - IVDs and Radiology Devices, 2015-2018 Other US Medical Device Regulations 2
J CEN/TR 17223:2018 Guidance on the relationship between13485 and MDR.. worth the money?? ISO 13485:2016 - Medical Device Quality Management Systems 2
Watchcat De novo Summary (ODE 2015-2018) Other US Medical Device Regulations 2
P Average Peel Strength - Interpretation of BS EN 868-5:2018 and ASTM F0088/F0088M Other Medical Device Related Standards 2
P ISO 10993-1:2018 - When will the European equivalent become a Harmonized Standard? Other Medical Device Related Standards 13
Watchcat Office of In Vitro Diagnostic and Radiological Health (OIR) De novos 2018 Other US Medical Device Regulations 1
M Informational Health Canada – Drug and medical device highlights 2018: Helping you maintain and improve your health Medical Device and FDA Regulations and Standards News 1
Watchcat Informational ODE DE NOVOs 2018 Other US Medical Device Regulations 1
M Informational Medicines and Healthcare Products Regulatory Agency Annual Report and Accounts 2018 to 2019 Medical Device and FDA Regulations and Standards News 0
M Inputs on definition of very similar processes for multi site audit sample - IAF MD1 2018 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Sterilization Site Move - Dec 2018 FDA Guidance Document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S When is the last date for transition to ISO/IEC 80079-34:2018? Other ISO and International Standards and European Regulations 0
E ISO TC 34 and ISO 22000:2018 Gap Analysis and the principles of Codex Alimentarius Food Safety - ISO 22000, HACCP (21 CFR 120) 1
Ashok sunder Need ISO 45001:2018 HIRA template Occupational Health & Safety Management Standards 9
L VDA 1 Documented Information and Retention (new revision 4, August 2018) VDA Standards - Germany's Automotive Standards 0
Ashok sunder ISO 45001:2018 Documentation template Occupational Health & Safety Management Standards 4
M Medical Device News Last update of the MDR and IVDR implementing measures rolling plan – December 2018 Medical Device and FDA Regulations and Standards News 0
Marc Renewables, led by wind, provided more power than coal in Germany in 2018 Sustainability, Green Initiatives and Ecology 2
Marc As the earliest wind farms age - Dec 2018 Ars article Sustainability, Green Initiatives and Ecology 4

Similar threads

Top Bottom