PMCF (Post Market Clinical Followup) Enrollment Sizes (Spinal Implants)

Chrisx

Involved In Discussions
#1
Our notified body is asking for PMCF studies with sufficient enrollment to evaluate all product variants. I don't think they have considered what that entails for a spinal implant. Has anyone had a similar question. It makes sense on the surface, until you do the math. For example, our anterior cervical plate has 41 different sizes, times 15 different screw sizes times enrollment of say 20 patients, comes to 12,300 patients. I guess you could do a DOE, but I never heard of a DOE PMCF study. This is actually one of our simpler systems. For one of our stand-alone interbodies, enrollment could be in the 100,000 or more. I just find it hard to believe this same question is being posed to other manufacturers of spinal implants.
 
Elsmar Forum Sponsor

Chrisx

Involved In Discussions
#3
DOE stands for design of experiments. It is statistical tool used to reduce the number of experiments in a study that has multiple variables. I think it would be highly unusual to use it for PMCF.
 

Marcelo

Inactive Registered Visitor
#4
Does the clinical performance (including clinical benefits) and clinical safety of the devices change between variants?Did you CER identified, fully disclosed, and evaluated the differences between variants and give explanations explanations as to why the differences are not expected to significantly affect the clinical performance and clinical safety of the device under evaluation? (I adapted this fro m the text of the MEDDEV about equivalent devices, but the idea is the same).

I've had some questions asked related to variants in the past and the answer to these questions was enough to fulfill the expectations of NBs.
 
J

Julie O

#5
Ah, of course. Yes, unusual, but then it's an unusual situation. Otherwise I had the same thought as Marcelo. Plan C - get a new NB. :(
 

Chrisx

Involved In Discussions
#6
They backed off a bit from their initial stance. They accepted that if equivalence could be demonstrated across a product family, then the sample size could be smaller. However, this was not stated in their nonconformity. We will see if they accept our equivalence rationale.

Thanks
ChrisX
 
Thread starter Similar threads Forum Replies Date
A Post-market clinical followup studies (PMCF) EU Medical Device Regulations 16
M PMCF (Post Market Clinical Followup)/ PSUR template EU Medical Device Regulations 8
S PMCF (Post Market Clinical Followup): Rationale for Exemption - Software Medical Devices EU Medical Device Regulations 6
W Interesting Discussion PMCF (Post-Market Clinical Followup) vs PMCF studies EU Medical Device Regulations 36
S Understanding PMS (Post Market Surveillance) and PMCF (Vigilance and PMCF) Quality Manager and Management Related Issues 1
S PMS (Premarket Submission) and PMCF Plan EU Medical Device Regulations 5
M Clinical Evaluation Plan vs. PMCF Plan EU Medical Device Regulations 19
A CE Mark and PMCF study EU Medical Device Regulations 3
M MDR - Under what circumstances is a PMCF not required? EU Medical Device Regulations 1
R PMCF - centers/countries used CE Marking (Conformité Européene) / CB Scheme 0
R PMCF plan to justify that our product not require PMCF study EU Medical Device Regulations 2
BreeJeong PMCF study plan is same to clinical investigation plan? EU Medical Device Regulations 3
S Do subjects pay for a medical implant in PMCF study? Quality Manager and Management Related Issues 3
Q Is there a way that I can combine two PMCF studies into one? EU Medical Device Regulations 4
B Inquiry about MEDDEV 2.12/2 rev2 - PMCF studies EU Medical Device Regulations 3
L Residual risks which the PMCF study is based on ISO 14971 - Medical Device Risk Management 7
C Production and Post Production feedback - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 4
R Impact of changing manufacturer post clinical investigation CE Marking (Conformité Européene) / CB Scheme 3
N Post Market Surveillance Package Example Wanted ISO 13485:2016 - Medical Device Quality Management Systems 1
M Differences in post market safety reporting for Combination Product Applicants Medical Device and FDA Regulations and Standards News 1
K Product (Device) Life cycle - Product Life AFTER the Post Market Phase Medical Device and FDA Regulations and Standards News 3
M Status of Medical Device Regulations in UK Post-Brexit Other Medical Device Regulations World-Wide 10
M Post Market Surveillance for Class II Medical Devices Medical Device and FDA Regulations and Standards News 2
N Post registration variation to medical device Other Medical Device Regulations World-Wide 1
H Post-market surveillance strategy EU Medical Device Regulations 1
B Procedures for Complaint Handling and Post Market Surveillance EU Medical Device Regulations 7
Z Role of economic operators (EO) post the EU MDR Date of application in May 2020 EU Medical Device Regulations 1
M Informational Creating a post market surveillance (PMS) system for medical devices – Part 1 Medical Device and FDA Regulations and Standards News 7
E Post Market Surveillance Standard Various Other Specifications, Standards, and related Requirements 4
T Post-Market Surveillance Plan - Requirements outlined in Annex III (1.1b) EU Medical Device Regulations 2
Ashok sunder Is it possible to reduce Risk likelihood and impact Post control Ranking after corrective action taken for risk? FMEA and Control Plans 1
DuncanGibbons Why is 8.4 post-delivery activities before 8.6 release of products and services in AS9100D? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Y Post Market Surveillance Indicators and Analysis method EU Medical Device Regulations 1
M Post Market Surveillance Plan Template EU Medical Device Regulations 6
F Vietnamese Post-Market Surveillance Requirements for a medical device in Japan Other Medical Device Regulations World-Wide 0
S Post Market Surveillance and Annual Product Review in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2
Kuldeep Singh Post Market Clinical Follow up and CE Marking for Class IIb medical X-Ray products CE Marking (Conformité Européene) / CB Scheme 1
J Delete post - How to delete post? Elsmar Xenforo Forum Software Instructions and Help 4
M Medical Device News Health Canada Notice of intent: Strengthening the post-market surveillance and risk management Canada Medical Device Regulations 1
Marc User Post Counts - 20181101 Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
S Is management representative a temporary post or a job title Management Review Meetings and related Processes 16
A Return information production and post production ISO 13485:2016 - Medical Device Quality Management Systems 1
K EU MDR - PMS (Post Market Surveillance) SOP - definition of "register(s)" EU Medical Device Regulations 2
S An auditor asked for a Post Market Surveillance Report ISO 14971 - Medical Device Risk Management 4
K Where does the FDA post its various compliance dates? US Food and Drug Administration (FDA) 2
T Proactive / Preventive Post Market Surveillance question ISO 13485:2016 - Medical Device Quality Management Systems 4
M ISO TR 20416 Medical Devices - Post-Market Surveillance for Manufacturers Other Medical Device Related Standards 6
B AS9100 Scope of Registration - Post-Delivery Activities N/A? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
S Merging Post Market Surveillance and Complaint Handling ISO 13485:2016 - Medical Device Quality Management Systems 3
K What can be considered a "Post Delivery Activity" (ISO 9001:2015 Clause 8.5) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17

Similar threads

Top Bottom