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MDR 2017/745 Basic UDI-DI, UDI-DI & UDI-PI

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A Can anyone share a Distribution Agreement template under MDR 2017/745? EU Medical Device Regulations 0
K Applicability of Cybersecurity EU MDR 2017/745 Annex 1 23.4(ab), 14.2(d) CE Marking (Conformité Européene) / CB Scheme 3
K Applicability of eIFU as per EU MDR 2017/745 Annex 1 23.1 CE Marking (Conformité Européene) / CB Scheme 0
R Declaration of conformity as per EU MDR (2017/745) CE Marking (Conformité Européene) / CB Scheme 5
K Supply Agreement Regarding MDR 2017/745 - Manufacturer-supplier cooperation Other Medical Device Related Standards 0
T Commission proposal being drawn up for postponement for date of application of MDR (2017/745) EU Medical Device Regulations 7
F Will the EU postpone 2017/745 MDR Implementation - COVID-19 Impact Medical Device and FDA Regulations and Standards News 11
M Informational Is my device a Reusable Surgical Instrument under the EU MDR(2017/745)? Medical Device and FDA Regulations and Standards News 0
D MDR 2017/745 Classification Guide EU Medical Device Regulations 8
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
M Informational New designated Notified Body for Regulation (EU) 2017/745 (MDR) included in Nando – IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. Medical Device and FDA Regulations and Standards News 3
M Informational Some things the EU MDR 2017/745 does not tell you, but you may need to know to comply with it effectively – Part 1 Medical Device and FDA Regulations and Standards News 0
O New MDR 2017/745 Transition Strategy - 2019 Manufacturing and Related Processes 3
xcanals_tecno-med.es Qualification of sterilization indicators as medical devices with the EU MDR 2017/745 EU Medical Device Regulations 7
G Pyrogen Test - Sterilization Validation - MDR 2017/745 Other ISO and International Standards and European Regulations 6
G Pyrogen Test - MDR 2017/745 Other ISO and International Standards and European Regulations 2
M MDR 2017/745 sterile and non-sterile labeling EU Medical Device Regulations 12
M Informational EU – Medical devices: Implementation of Regulation (EU) 2017/745 on medical devices (MDR) – Information from the Irish and German delegations Medical Device and FDA Regulations and Standards News 0
F Interpretation of MDR 2017/745 Article 23 - CE Mark Requirements EU Medical Device Regulations 8
I 2017/745 (MDR) - Instruction for use (IFU) - manufacturer's website EU Medical Device Regulations 15
C Usability IEC 62366-1:2015 and MDR 2017/745 - Risk based approach IEC 62366 - Medical Device Usability Engineering 1
F EU MDR 2017/745 Rolling Plan Medical Device and FDA Regulations and Standards News 4
moounir Medical Device Nomenclature - Free of Charge? (European Union MDR MDR 2017/745) EU Medical Device Regulations 7
G EU MDR 2017/745 Rule 11 interpretation - Re-classification of a Software as Medical Device Other Medical Device Related Standards 0
M Informational Scope of BSI for the MDR – Regulation (EU) 2017/745 on medical devices Medical Device and FDA Regulations and Standards News 0
W TF according to MDR 745/2017 CE Marking (Conformité Européene) / CB Scheme 5
D Responsible for regulatory compliance (Article 15 of MDR 2017/745) Quality Manager and Management Related Issues 4
S MDR (Medical Device Regulations 2017/745) training recommendation for Auditors EU Medical Device Regulations 1
R MDR 745/2017 keynote - I'm a student and I'm writing a thesis EU Medical Device Regulations 4
Ronen E Transition to MDR (EU 2017/745) - I'd like to make an offer EU Medical Device Regulations 12
M Informational EU – Next Notified Body designated to the MDR 2017/475 is IMQ S.p.A from Italy Medical Device and FDA Regulations and Standards News 0
shimonv The new "features" of the MDR - Dec 2017 EU Medical Device Regulations 4
Sam Lazzara EU MDR Safety & Performance Requirements vs. MDD ERs (June 2017) EU Medical Device Regulations 3
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 MDR requirement where unit of use packaging is too small for UDI carrier EU Medical Device Regulations 1
S MDR GSPR Standards EU Medical Device Regulations 0
A MDR - Legacy Device Review Timeframe and Requirements EU Medical Device Regulations 3
J Translation requirements for the statement referred to in ANNEX XIII of MDR EU Medical Device Regulations 0
J EU MDR GSPR 10.4.3 and 10.4.4 EU Medical Device Regulations 2
F Labelling to comply with both FDA and MDR US Food and Drug Administration (FDA) 6
N EU MDR and its impact on existing Registrations EU Medical Device Regulations 1
M Post Market Safety Update Report for devices that will be up-classified under MDR but are currently under MDD EU Medical Device Regulations 3
Y MDR Transition - make "Available on the market" after CE certificate expiration EU Medical Device Regulations 2
C MDR Classification Rule 10 EU Medical Device Regulations 13
C MDR software classification EU Medical Device Regulations 12
Y MDR requirements for Class I accessories EU Medical Device Regulations 2
M MDR legal actions - manufacturers CE Marking (Conformité Européene) / CB Scheme 8
R Products not within the MDR grace period EU Medical Device Regulations 1

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