Anyone had an MDR technical file review/audit yet?

Watchcat

Trusted Information Resource
#1
I know the NBs have been prioritizing (frantically) MDD renewals. I am not sure how MDR tech file reviews and audits have fit into their priorities and schedules so far. Has anyone here had one?
 
Elsmar Forum Sponsor

Watchcat

Trusted Information Resource
#3
Thanks for the reply. I am mostly interested in timeframes:

- From application to tech file review/acceptance.
- From tech file review/acceptance to audit.
- From audit to certificate.

Device class might be interesting to know, too.

Would also be interested to know which NB, but if you are not comfortable sharing that information, perhaps whether it is (BSI/TUV) versus one of the NBs that was designated in the last few months?

As for anything more substantive about the review, it is hard to know what to ask. Everyone has been struggling with many issues, due to having only the language of the MDR as their guide, few guidances to clarify/expand on the meaning of the language, and, sometimes, no guidance from their overwhelmed NB, either. So I guess I will just add that, if you found anything about the experience especially enlightening and that you would be comfortable sharing, that would be good to know too.
 
#4
Our Audit was last year in December. Unfortunately we are still waiting for our certificate. We are manufacturer of class IIa medical devices in Germany.
The Tech file review lasted about 3 month. Our NB is TUV.

I recommend an intensive exchange with the notified body and the responsible auditor. This helped us a lot!

Important topics are:
-Vigilance
-Post Market Surveillance: PMS, PSUR, PMCF
-UDI, MDRLabeling
 

Watchcat

Trusted Information Resource
#5
Thanks! As I'm sure you know, rumors abound, including with respect to timeframes. It seems like Elsmar offers an opportunity to find out more in the way of actual experiences and less in the way of dire predictions.
 
#6
Our Audit was last year in December. Unfortunately we are still waiting for our certificate. We are manufacturer of class IIa medical devices in Germany.
The Tech file review lasted about 3 month. Our NB is TUV.

I recommend an intensive exchange with the notified body and the responsible auditor. This helped us a lot!

Important topics are:
-Vigilance
-Post Market Surveillance: PMS, PSUR, PMCF
-UDI, MDRLabeling
Thanks! Can you tell, which aspects of UDI were reviewed at this phase, while UDI carrier is not yet a requirement (Date of application in 2021 earliest)?
 
#7
Thanks! Can you tell, which aspects of UDI were reviewed at this phase, while UDI carrier is not yet a requirement (Date of application in 2021 earliest)?
yes, that is correct and that was our assumption. But our NB was not interested in these transitional periods. That also surprised us a little bit. He wanted to see that we have already implemented the complete requirements for UDI.
 
#8
Ok, thanks a lot! I was planning on having a procedure ready in the QMS for UDI and Eudamed, but leaving implementation of the UDI carrier in labels for later...
 

Watchcat

Trusted Information Resource
#10
Unfortunately we are still waiting for our certificate.
It's always been my expectation that a massive number of MDD renewal and MDR original certificates will be issued on or about May 25, hopefully a result of efficiency, rather than procrastination.

I know that's how I'd do it. What companies need right now are not certificates, but tech file reviews and audits, so I'd focus single every resource I had on those, right up to the deadline. Then when time was finally too short for more reviews and audits, I'd queue up all the certificates and issue them en masse. I don't know exactly what that process looks like, but seems like it would be well suited for "en masse."

PS I'd be wildly impressed if one or more of the NBs had taken the opportunity to move away from paper certificates, but can't say I'm wildly optimistic.
 
Thread starter Similar threads Forum Replies Date
M Has anyone has been through an MDR audit? (3/2020) EU Medical Device Regulations 1
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
S Anyone Familiar with "SPC for Excel" add-in? Lean in Manufacturing and Service Industries 4
M Has anyone heard of Run at Risk? Manufacturing and Related Processes 14
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 21
B ASA Aviation Supply Association - Has anyone heard of ASA? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
B Has anyone done an IEC 60601-1 gap analysis to IEC 60335? Medical Device and FDA Regulations and Standards News 4
D Has anyone had sudden challenges from Korea-MFDS? Other Medical Device Regulations World-Wide 1
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
F Hi friends, can anyone show me an example of a procedure for ISO 13485 6.4.1 Work Environment? ISO 13485:2016 - Medical Device Quality Management Systems 2
W Does anyone have an API Q2 checklist for internal auditing? Oil and Gas Industry Standards and Regulations 1
Ronen E Can anyone please explain this? (510k submission requirement) Other US Medical Device Regulations 14
GreatNate Metrotom - Does anyone have any exposure to the Zeiss Metrotom 800 or 1500? Manufacturing and Related Processes 0
D FDA Biomarker Qualification Program - Has anyone prepared an application? Medical Device and FDA Regulations and Standards News 0
T Is anyone working with N299.1 (Supply/service to nuclear power plants)? Various Other Specifications, Standards, and related Requirements 0
GreatNate QMS in SharePoint - Is anyone doing this? Manufacturing and Related Processes 7
M Honda Audits - Does anyone have any experience with the QAV audit? General Auditing Discussions 2
G Anyone working with or planning to do business in the CBD (cannabidiol) industry? US Food and Drug Administration (FDA) 1
L Has anyone heard of the 2 pan system? Manufacturing and Related Processes 6
Q Does anyone have experience implementing a QMS without ISO certification? Quality Manager and Management Related Issues 2
J Does anyone here use ISOXpress/IMSXpress QMS software? Software Quality Assurance 11
K Does anyone have a copy of a GM 5 Phase Problem solving form Problem Solving, Root Cause Fault and Failure Analysis 1
M Has anyone here assessed the latest Abbreviated 510(K) guidance document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Does anyone has a good verification and validation plan template? ISO 13485:2016 - Medical Device Quality Management Systems 3
D Has anyone undergone a BARDA (HHS) audit as part of their grant process? Other Medical Device Regulations World-Wide 0
QIE Anyone have experience with BPA Quality (QMS system based on Office365/Sharepoint) Quality Assurance and Compliance Software Tools and Solutions 1
M AMS0320 - Electro-deposition of zinc - Anyone come across this spec? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
M Anyone Dropping IATF and going back to ISO ? IATF 16949 - Automotive Quality Systems Standard 18
Sidney Vianna LinkedIn bug - Anyone has any idea of how to fix this? Posts not showing for me in a Group feed. Coffee Break and Water Cooler Discussions 2
R Anyone who can share a checklist for ISO 29134? IEC 27001 - Information Security Management Systems (ISMS) 7
G Can anyone tell me about Tooling FMEA FMEA and Control Plans 3
B Does anyone charge for annual layouts? APQP and PPAP 8
C Will anyone please share training material for ISO:13485:2016 for best practices Training - Internal, External, Online and Distance Learning 0
K Has anyone used QAI for training? Training - Internal, External, Online and Distance Learning 7
N Does anyone know a registrar that offers both ISO 9001 and ISO 17020? Registrars and Notified Bodies 6
W Does anyone have any experience with the Easy Metric System? General Measurement Device and Calibration Topics 2
J Does anyone have a good APQP template that meets IATF requirements? APQP and PPAP 3
A Anyone have experience with Transmille calibrators General Measurement Device and Calibration Topics 1
D Has anyone here had any experience with PQ-FMEA software? FMEA and Control Plans 1
D IATF 16949 - 8.5.2.1 Traceability Plan - Does anyone have an example? IATF 16949 - Automotive Quality Systems Standard 4
C Upgrading from ISO 9001:2015 to IATF 16949:2016 - Anyone have a gap analysis tool? IATF 16949 - Automotive Quality Systems Standard 2
C Does anyone have an AS9100:2015 audit schedule template? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
S Has anyone completed IATF 16949 Certification - Share your Audit Experience? IATF 16949 - Automotive Quality Systems Standard 2
S Has anyone created a Turtle Diagram reflecting the new ISO 9001:2015 Structure? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Does anyone have example test report of defibrillator IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
R Can anyone tell me requirements standards for insufflator? Other Medical Device Related Standards 1
Q Is anyone using MasterControl Spark? I have a question ISO 13485:2016 - Medical Device Quality Management Systems 8
L Can anyone enlighten me on the use of AAMI HE-74? Other Medical Device Related Standards 6
M Has anyone done a Gage R&R for Spectrophotometer? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
Similar threads


















































Top Bottom