SBS - The best value in QMS software

EU MDR Safety & Performance Requirements vs. MDD ERs (June 2017)

Sam Lazzara

Trusted Information Resource
#1
I have begun my slow EU MDR digestion process by drafting a cross-reference between the MDR S&PRs versus the MDD ERs (Essential Requirements). You can access it here.

If you are interested in a MS Word version, click here.

I did my best to correlate the "old" Essential Requirements to the "new" Safety & Performance Requirements, but there is always a chance I screwed up. So please let me know if you see any problems, or see ways to improve it.
 
Elsmar Forum Sponsor

MDRexpert

Involved In Discussions
#2
Hi Sam,

The link doesn't work anymore for Europe MDR 2017/745 General Req vs. MDD 93/42/EEC Essential Req. Can you please upload the document here? Thanks!
 
T

tox472

#3
Hi Sam,
Thanks for sharing. BSI has issued an interesting white paper on this subject, if it can help in consolidating.
«General Safety and Performance
Requirements (Annex I) in the New
Medical Device Regulation
Comparison with the Essential Requirements of the Medical
Device Directive and Active Implantable Device Directive»
Gaëlle
 

MDRexpert

Involved In Discussions
#4
Hi Sam,

The link doesn't work anymore for Europe MDR 2017/745 General Req vs. MDD 93/42/EEC Essential Req. Can you please upload the document here? Thanks!
Just wanted to mention that for some reason the document does not open in IE. I tried again in google chrome and was able to see it.

Thanks Sam!
 
Thread starter Similar threads Forum Replies Date
D Summary of safety and clinical performance in GSPR MDR EU Medical Device Regulations 2
M Informational MHRA guidance updated to reflect the mDR – Clinical investigations of medical devices – Biological safety assessment Medical Device and FDA Regulations and Standards News 1
P EU MDR and PSUR (Periodic Safety Update Report) EU Medical Device Regulations 40
Ed Panek Upcoming NB MDD ---> MDR Crunch EU Medical Device Regulations 0
S MDR - System and procedure pack article 22 and all sub processes that apply ISO 13485:2016 - Medical Device Quality Management Systems 0
C Requirements for distributors under MDR: translation EU Medical Device Regulations 0
A Should we assign the PRRC before the date of application of MDR (26 May 2021)? EU Medical Device Regulations 0
N Looking for a recommendation for an EU MDR Importer EU Medical Device Regulations 1
JoCam Rental and MDD versus MDR 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 3
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 1
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 4
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 18
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
U MDD Article 12/ MDr Article 22 interpretation EU Medical Device Regulations 2
E MDR internal audit Internal Auditing 1
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