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
Watchcat Anyone had an MDR technical file review/audit yet? EU Medical Device Regulations 13
K EU MDR Annex 1 Chapter III: Information in the Instructions for Use-23.4 (e) the performance characteristics of the device; EU Medical Device Regulations 1
R Requirements for MDR Article 22 Systems EU Medical Device Regulations 1
H EU MDR Economic Operator notifications? EU Medical Device Regulations 1
M MDR EU Distributor for our CE Mark product in the for Netherlands EU Medical Device Regulations 6
R Declaration of conformity as per EU MDR (2017/745) CE Marking (Conformité Européene) / CB Scheme 4
K Class III Kit Box - Are translations mandatory under EU MDR? EU Medical Device Regulations 4
B Herbal ingredients MDR EU Medical Device Regulations 0
S MDR GSPR Clause 17 - Software Requirements EU Medical Device Regulations 2
N Which EN ISO 17664 version compliance to EU MDR? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
D Hospital Decontamination and the MDR - Technical Files, UDI and PMS EU Medical Device Regulations 2
K Submission of MDR File - Partner Companies - Computed Tomography (CT) CE Marking (Conformité Européene) / CB Scheme 10
B How to classify a medical device based on MDR? EU Medical Device Regulations 3
A MDR GSPR Checklist wanted EU Medical Device Regulations 3
Rincewind MDR - GSPR - Annex I - Chapter II EU Medical Device Regulations 2
N EU MDR - Applicability Article 22 Systems and Procedure Packs CE Marking (Conformité Européene) / CB Scheme 4
B EU MDR Perscription product guidance EU Medical Device Regulations 1
cscalise Suggestions for MDR Auditing tools EU Medical Device Regulations 1
M Example of statement for procedure pack MDR Article 22? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
H MDD CM, MDR manufacturer. 2020. Is it ok? EU Medical Device Regulations 1
M MDR, RED and LVD - Should our device comply with them? EU Medical Device Regulations 2
E UK MDR brexit out of sync with EU MDR deadline? Other Medical Device Regulations World-Wide 2
S MDR Delay - MDD design Change? (before new MDR DOA) EU Medical Device Regulations 8
S Class I MDR Article 10 – QMS EU Medical Device Regulations 1
dgrainger Medical Device News MDR postponed - link to Official Journal of the European Union (24-4-2020) EU Medical Device Regulations 2
K Supply Agreement Regarding MDR 2017/745 - Manufacturer-supplier cooperation Other Medical Device Related Standards 0
Ed Panek Medical Device News MDR Delayed 1 year (Posted 4/2020) EU Medical Device Regulations 9
dinaroxentool Former Class I device that is upscaled to IIa if the MDR is delayed EU Medical Device Regulations 2
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
J PPE, the MDR and EU 2016/425 EU Medical Device Regulations 4
R An indication that the device is a medical device (MDR, Annex 23.2q) - applicable for accessories? EU Medical Device Regulations 5
R Clinical evaluation without clinical data - MDR Article 61(10) EU Medical Device Regulations 6
dgrainger Informational Postponement of MDR - adopted by the Commission - April 2020 Medical Device and FDA Regulations and Standards News 3
R Applicability of new non-harmonized standards (MDD/MDR) EU Medical Device Regulations 8
F The EU Drafts Bill to Postpone MDR by a Year (3/2020) Medical Device and FDA Regulations and Standards News 2
T Commission proposal being drawn up for postponement for date of application of MDR (2017/745) EU Medical Device Regulations 7
A MDR Article 22 applicability - Legal manufacturer EU Medical Device Regulations 6
M Estimating the benefit-risk ration under MDR EU Medical Device Regulations 1
F Will the EU postpone 2017/745 MDR Implementation - COVID-19 Impact Medical Device and FDA Regulations and Standards News 11
Ajit Basrur Physical Address on Product Labels (EU MDR perspective) EU Medical Device Regulations 2
B Notified Bodies for Software (MDR) EU Medical Device Regulations 1
P MDR Rule 10 interpretation - Active Device EU Medical Device Regulations 3
JoCam Certified Body Audit of MDR requirements EU Medical Device Regulations 4
N Label Placement Requirement in MDD/MDR EU Medical Device Regulations 1
C MDR - Question around software accesories EU Medical Device Regulations 2
M Has anyone has been through an MDR audit? (3/2020) EU Medical Device Regulations 1
M MDR - Packaging - Secondary Medical Device Boxes EU Medical Device Regulations 2
adir88 MDR requirement: Risk Management Plan for "each device" ISO 14971 - Medical Device Risk Management 5
N Whether your NB is pushing you for MDR? Registrars and Notified Bodies 0
M MDR - Is a formal GSPR Procedure required? EU Medical Device Regulations 20
Similar threads


















































Top Bottom