SBS - The best value in QMS software

EU-MDR Article 9-common specifications

Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#3
I was having a hard time trying to articulate what *I* thought they would be and so I googled around a bit and found this link. I think it does a pretty good job of explaining (I have no relationship with the Johner Institute). I don't know how many common specifications have been established but in all the googling, I ran across this RAPS article talking about the common specifications established for reprocessing single use devices.

Hopefully between the 2 items, that gives you a better idea.
 
Thread starter Similar threads Forum Replies Date
M Examples of Combination Products - MDR Article 1 (8) and MDR Article 1(9) Medical Device and FDA Regulations and Standards News 3
U MDD Article 12/ MDr Article 22 interpretation EU Medical Device Regulations 2
M MDR Article 22 Interpretation EU Medical Device Regulations 3
L EU MDR Article 86 PSUR EU Medical Device Regulations 1
R Requirements for MDR Article 22 Systems EU Medical Device Regulations 1
N EU MDR - Applicability Article 22 Systems and Procedure Packs CE Marking (Conformité Européene) / CB Scheme 4
M Example of statement for procedure pack MDR Article 22? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
S Class I MDR Article 10 – QMS EU Medical Device Regulations 1
R Clinical evaluation without clinical data - MDR Article 61(10) EU Medical Device Regulations 6
A MDR Article 22 applicability - Legal manufacturer EU Medical Device Regulations 6
S Article 61 - MDR Clinical Investigation Requirement EU Medical Device Regulations 5
C Article 16 MDR - Medicine packaged together with Medical Device EU Medical Device Regulations 0
F MDR system/procedurepack (article 22) with device acc. to MDD and MDR CE Marking (Conformité Européene) / CB Scheme 2
N EUDAMED postponement and compliance with Article 120 (3) MDR for Legacy Devices EU Medical Device Regulations 8
R MDR Article 22: Systems and procedure packs Other Medical Device Regulations World-Wide 12
T EU MDR Article 61- Clinical Evaluation EU Medical Device Regulations 2
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
F Interpretation of MDR 2017/745 Article 23 - CE Mark Requirements EU Medical Device Regulations 8
E MDR Article 117 / Impact to New Marketing Authorization Applications Other Medical Device Regulations World-Wide 1
C Access to Technical Documentation - MDR Chapter VI Article 61 EU Medical Device Regulations 4
T MDR article 22 - System of 2 CE products and validation / usability? EU Medical Device Regulations 10
T Clarification on MDR - Article 18(d) - Implant Card EU Medical Device Regulations 14
M Is MDR Article 61(5) Unrealistic? EU Medical Device Regulations 9
D Responsible for regulatory compliance (Article 15 of MDR 2017/745) Quality Manager and Management Related Issues 4
S EU MDR - Liability Clause per article 31 EU Medical Device Regulations 22
S PSUR - MDR First Submission Requirement? EU Medical Device Regulations 1
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 7
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
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 3
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 2
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
S EU MDR Annex I Chapter III 23.4 z EU Medical Device Regulations 2
R MDR & depth of technical files review by NB's EU Medical Device Regulations 12
U EU-MDR: Complicated supply chain EU Medical Device Regulations 4
C EU MDR - Annex II 6.1 Pre-clinical and clinical data EU Medical Device Regulations 4
A IVD in MDR procedure pack EU Medical Device Regulations 2
Ed Panek IFU Contact Requirements - FDA and MDD/MDR US Food and Drug Administration (FDA) 1
S Are EC type examinations still being conducted under MDR? EU Medical Device Regulations 5
E MDR internal audit Medical Device and FDA Regulations and Standards News 0
R The term "Benefit Risk Ratio" in EU MDR, do I need to present benefit risk analysis as a RATIO Risk Management Principles and Generic Guidelines 4
R MDR, Annex I, 23.1 Interpretation - IFU on the website EU Medical Device Regulations 5
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0

Similar threads

Top Bottom