Informational EU MDR and IVDR Factsheet for healthcare professionals and health institutions

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P MDR/IVDR Annex III - Technical documentation on PMS EU Medical Device Regulations 1
M Informational EU – 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 2
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
Watchcat MDD, MDR/IVDR, Working Groups, Expert Panels, MEDDEVs and Other EU Guidances EU Medical Device Regulations 32
M Informational Update – MDR and IVDR implementing measures rolling plan – 2 more NBs designated under the new regulations Medical Device and FDA Regulations and Standards News 0
M Informational From RAPS – EU MDR/IVDR: US Raises ‘Serious Concerns,’ Urges 3-Year Implementation Delay Medical Device and FDA Regulations and Standards News 3
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 Medtech Europe presentation – – Industry Perspective on the Implementation Status of the MDR/IVDR Medical Device and FDA Regulations and Standards News 0
M Informational From RAPS – UK NB Will Not Apply for EU MDR/IVDR Medical Device and FDA Regulations and Standards News 11
M Informational Next meeting of the Medical Device Coordination Group (MDR/IVDR) – 20 June 2019 Medical Device and FDA Regulations and Standards News 2
M Informational EU – Corrigenda for MDR and IVDR published in Official Journal Medical Device and FDA Regulations and Standards News 0
M Informational EU – April 2019 update of the MDR and IVDR implementing measures rolling plan Medical Device and FDA Regulations and Standards News 0
M Medical Device News EU – Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) – infographics Medical Device and FDA Regulations and Standards News 0
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
M Informational Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (MDD/IMDD/IVDD) Medical Device and FDA Regulations and Standards News 5
M Medical Device News New guidance sheets for the MDR/IVDR published EU Medical Device Regulations 0
J IVDR and MDR ANNEX I Requirements Template EU Medical Device Regulations 7
M Medical Device News MDR and IVDR implementing measures rolling plan EU Medical Device Regulations 0
bio_subbu CAMD published FAQs to the transitional provisions of MDR and IVDR EU Medical Device Regulations 0
M MDR and IVDR to be published May 5th 2017 EU Medical Device Regulations 14
S MDR & IVDR Introduction in late May 2017 EU Medical Device Regulations 1
A Can anyone share a Distribution Agreement template under MDR 2017/745? EU Medical Device Regulations 0
A MDR ANNEX XI part A or Part B EU Medical Device Regulations 0
N OBL under the MDR. Which are the obligations of the OEM? EU Medical Device Regulations 0
U Distributor obligations under MDR EU Medical Device Regulations 1
Raisin picker CECP, consultation according to Art 54 MDR EU Medical Device Regulations 1
K Question on MDR classification EU Medical Device Regulations 4
M STED vs MDR EU Medical Device Regulations 0
F UDI-PI required on packaging (MDR) EU Medical Device Regulations 2
M Extension to shelf life of new product under MDR EU Medical Device Regulations 1
J Instructions for use for Class I devices under MDR EU Medical Device Regulations 1
K Importer in EU, but not distribute in the EU - MDR obligations EU Medical Device Regulations 0
K MDR Class 1 Self Certification - Competent Authority or Notified Body? EU Medical Device Regulations 6
M Responsibilities of Importers / Distributors - MDR EU Medical Device Regulations 3
S PSUR - MDR First Submission Requirement? EU Medical Device Regulations 2
R EU-MDR Article 9-common specifications Other ISO and International Standards and European Regulations 2
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
JoCam MDR Gap Analysis - Consultant fees EU Medical Device Regulations 10
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
M Examples of Combination Products - MDR Article 1 (8) and MDR Article 1(9) Medical Device and FDA Regulations and Standards News 3
P EU MDR Translation of Product Name EU Medical Device Regulations 0
N Is this a single integral drug device combination product EU MDR CE Marking (Conformité Européene) / CB Scheme 1
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
K Quality Agreement MDR - The manufacturer is outside of EU Other Medical Device Related Standards 4
M MDR - eIFU - When you can supply an electronic IFU instead of a paper IFU EU Medical Device Regulations 5
M MDR harmonized standards EU Medical Device Regulations 3
cscalise RAPS/Med Dev EU MDR Guidebook - Reviews or Opinions? EU Medical Device Regulations 0
V New Product Model CE Mark Certification under MDR EU Medical Device Regulations 0
E MDR PRRC "jointly responsible" EU Medical Device Regulations 1
J Strategy for MDR Regulatory Compliance Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4

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