SBS - The best value in QMS software

MDR review process by notified body - How many steps exist in the review process

Nono

Registered
#1
We are a manufacturer of a Class III medical device, marketing in Asia, US as well as EU.

Question: Do you know exactly how many steps exist in the review process of a medical device by notified body (from application to certification)?

Based upon my past experiences through a number of reviews with our notified body, their steps of review process seems to be as shown below:

Review by scheme manager -> Review by clinical oversight team -> Review by internal clinician -> Panel 1 review -> Panel 2 review -> Expert panel review(from MDR) -> Certification

Is your NB's process similar to above? Otherwise, are the steps of review different depends on each NB? If something is different, could you kindly indicate where is different?

Can anyone here shed some light on any of the above?
 
Last edited:
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
R MDR & depth of technical files review by NB's EU Medical Device Regulations 18
Watchcat Anyone had an MDR technical file review/audit yet? EU Medical Device Regulations 13
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 7
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 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
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 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
S EU MDR CAPA - GAP Assessment on CAPA SOPs EU Medical Device Regulations 1
M MDR Article 22 Interpretation EU Medical Device Regulations 3
A User interface Language Requirements - EU MDR EU Medical Device Regulations 1
L EU MDR Article 86 PSUR EU Medical Device Regulations 1
S How is the service life for class I reusable medical devices described in MDR? EU Medical Device Regulations 7
S How is the service life described for class I reusable medical devices in MDR? Elsmar Xenforo Forum Software Instructions and Help 1
P MDR/IVDR Annex III - Technical documentation on PMS EU Medical Device Regulations 1
E Our company is planning to file MDD not MDR next month. Do we require to show chemical characterization report ? CE Marking (Conformité Européene) / CB Scheme 1
S Classification of a product according to MDR EU Medical Device Regulations 3
L Classification under MDR EU Medical Device Regulations 1
I Interpretation of the MDR GSPR 23.4 (u) EU Medical Device Regulations 2
S Converting SOP MDD to MDR Noob ISO 13485:2016 - Medical Device Quality Management Systems 4
K Biological indicator system classification under MDR EU Medical Device Regulations 2
L 'Distributor' definition & MDR/MSR relationship EU Medical Device Regulations 3
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 4
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 5
G MDR translation requirements EU Medical Device Regulations 3
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
rob73 UK Medical Device Regulations Forum - UK MDR Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
J Intervertebral body fusion cage, MDR Class II or Class III? EU Medical Device Regulations 4

Similar threads

Top Bottom