Informational DRAFT: The Medical Devices (Northern Ireland Protocol) Regulations 2021

Download Free White Paper
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
dgrainger Informational DRAFT: The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 UK Medical Device Regulations 1
M Informational US FDA Draft Guidance – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal F Medical Device and FDA Regulations and Standards News 0
M Informational FDA draft guidance – Safer Technologies Program for Medical Devices Medical Device and FDA Regulations and Standards News 0
M Informational US FDA draft guidance – Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment Medical Device and FDA Regulations and Standards News 0
M Informational EU draft act – Single-use medical devices – safety and performance requirements for reprocessing Medical Device and FDA Regulations and Standards News 0
M Informational Draft ANSM’S GUIDELINE Cybersecurity of medical devices integrating software during their life cycle Medical Device and FDA Regulations and Standards News 0
M Informational Draft standardisation request as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Medical Device and FDA Regulations and Standards News 2
M Informational EMA – Consultation on draft guideline on quality requirements for medical devices in combination products Medical Device and FDA Regulations and Standards News 0
M Informational USFDA draft guidance – Technical Considerations for Non- Clinical Assessment of Medical Devices containing Nitinol Medical Device and FDA Regulations and Standards News 0
M Informational EU – Draft Functional specifications for the European Database on Medical Devices (Eudamed) – First release (High(1)) to be audited Medical Device and FDA Regulations and Standards News 0
S China 2018 draft Amendments to the Regulations on the Supervision and Administration of Medical Devices China Medical Device Regulations 1
P Understanding FDA draft "Management of Cybersecurity in Medical Devices" Medical Information Technology, Medical Software and Health Informatics 3
M Medical Device News FDA Releases Draft Recommendations on Premarket Submissions for Management of Cybersecurity in Medical Devices Other US Medical Device Regulations 0
Ajit Basrur WHO Draft document - Regulatory Framework for Medical Devices Other Medical Device Regulations World-Wide 0
bio_subbu GHTF Issues Draft Guidance Document on UDI System for Medical Devices Other Medical Device Related Standards 1
bio_subbu CDSCO Published Draft version of Medical Devices Guidance Documents Other Medical Device Regulations World-Wide 3
bio_subbu Egyptian MOH published ?Draft Regulation for Medical Devices? Other Medical Device Regulations World-Wide 2
J EN 93/42 revised draft (harmonized) - Medical Devices Various Other Specifications, Standards, and related Requirements 1
Al Rosen Draft Revision of EU Medical Devices Directive 93/42/EEC ISO 13485:2016 - Medical Device Quality Management Systems 1
dgrainger Informational DRAFT - Common specifications for the groups of products without an intended medical purpose listed in Annex XVI. EU Medical Device Regulations 0
M Informational IMDRF draft document – Principles and Practices for Medical Device Cybersecurity Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Patient Engagement in Design and Conduct of Medical Device Clinical Investigations Medical Device and FDA Regulations and Standards News 0
M Informational IMDRF draft document – Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews Medical Device and FDA Regulations and Standards News 0
M Informational Publication of Draft Health Canada Implementation Guidance for the International Medical Device Regulators Forum Table of Contents Format Medical Device and FDA Regulations and Standards News 0
S 'Clean' Draft Medical Device Regulations Published EU Medical Device Regulations 0
bio_subbu USFDA issues draft Guidance on the Acceptance of Medical Device Clinical Data Other US Medical Device Regulations 1
sagai New Draft Guidance for Medical Device Development Tools Other US Medical Device Regulations 3
Y New Draft FDA Guidance for Applicability of GLP in Medical Device Submission Other US Medical Device Regulations 2
S FDA Draft Guidance on Mobile Medical Applications US Food and Drug Administration (FDA) 1
bio_subbu FDA issues first draft guidance document on Mobile Medical Applications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
P E-Labeling Regulations Draft - Medical Device Electronic Instructions for Use (IFUs) EU Medical Device Regulations 1
J Draft Guidance: eMDR - Electronic Medical Device Reporting (Updated) US Food and Drug Administration (FDA) 3
Watchcat New Draft Guidance on Content of Premarket Submissions for Software Device "Functions" Other US Medical Device Regulations 2
J Can we register non-device clinical decision support software under draft guidance? Other US Medical Device Regulations 5
T Draft of New UK Regulations? UK Medical Device Regulations 2
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Medical Device and FDA Regulations and Standards News 0
C FMEA Process assessment In the Draft for the AIAG/VDA FMEA Manual is gone FMEA and Control Plans 0
M Informational US FDA Draft Guidance – Clinical Decision Support Software Medical Device and FDA Regulations and Standards News 0
M Informational From Medtech Insight – QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; Medical Device and FDA Regulations and Standards News 0
M Informational Several US FDA draft guidances, including some specific device guidances for the Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 0
M Informational US FDA draft guidance. – Clinical Investigations for Prostate Tissue Ablation Devices Medical Device and FDA Regulations and Standards News 2
M Informational US FDA draft guidance – Mouse Embryo Assay for Assisted Reproduction Technology Devices Medical Device and FDA Regulations and Standards News 0
L Getting Notice of Revision and Accessing Public Draft Copies of ISO Standards Service Industry Specific Topics 2
M Informational USFDA draft guidance – Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Draft Guidance – Review and Update of Device Establishment Inspection Processes and Standards Medical Device and FDA Regulations and Standards News 0
M Informational USFDA draft guidance – A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry Medical Device and FDA Regulations and Standards News 0
M Dynamic Control Plan Draft - need review FMEA and Control Plans 2
Y My mission is to draft a procedure related to ISO 14155 - Good Clinical Investigation Practices Other Medical Device Related Standards 1
M Informational USFDA Draft Guidance – Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation – Non-clinical Testing and Clinical Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom