Do you have a Medical Device PostMarket Surveillance Plan?

SK13485

SK13485

MedDev QA/RA
Hi:bigwave:,

Do you have a Medical Device Post Market Surveillance plan? This system has been there for some time in few markets. Are the regulatory agencies currently in an enforcement mode to apply this to the Medical devices? Have your auditor audited your PMS system or asked any questions or raised any concerns?

Some of the regulatory agencies got the plans well detailed. But they never talk about anything in terms of the acquisition of data. They want to enforce this on to the manufacturers with all regulations set forth for us. How about the Hospitals and Clinics and other research facilities? Why don't they have some regulations in place for them as well to co-operate with the manufacturer for PMS?

Talking about the proactive monitoring, We had a hard time so far. The feed back, surveys and so on we receive from our clients are incomplete. That data is not useful. Customers want our sales guys to buy them lunch for filling surveys. lol.. This is totally on another level...:D

I would be glad to hear your stories on implementation of PMS in your organization. Please feel free to join this conversation and share your ideas.

LETS CAGE THE ELEPHANT :whip:

SK
 
W

Wolf.K

Quite Involved in Discussions
Yes, we have a PMs Plan for each MD family, and write a PMS report annually or bi-annually for the Management Review. According to FDA Title 21 part 822 "postmarket surveillance", ISO 13585:8.5 "improvement", MEDDEV 2.12-1 and -2. Currently updating for compliance with EU MDR chapter VII.

Our Notified Body is always very happy with our documents.
 
P

pavel

:) hello.
I am also interested in these templates.
Thanks in advance, I will wait for an answer :popcorn:
 
W

Wolf.K

Quite Involved in Discussions
Hi,

the update process for MDR is not finished yet, I will post the templates when I am done with the work. As our notified body is still waiting for the accredition, we are still audited according to old MDD, not MDR...
 
Watchcat

Watchcat

Trusted Information Resource
SK13485 said:
Hi:bigwave:,
Some of the regulatory agencies got the plans well detailed. But they never talk about anything in terms of the acquisition of data. They want to enforce this on to the manufacturers with all regulations set forth for us. How about the Hospitals and Clinics and other research facilities? Why don't they have some regulations in place for them as well to co-operate with the manufacturer for PMS?

Talking about the proactive monitoring, We had a hard time so far. The feed back, surveys and so on we receive from our clients are incomplete. That data is not useful. Customers want our sales guys to buy them lunch for filling surveys. lol.. This is totally on another level...
Click to expand...

Don't get me started. PMS is mostly smoke and mirrors, an effort to chase down bad horses, rather than close the barn door.

Product regulation is about consumer confidence, not consumer safety. PMS data are usually garbage, but serves many agendas to believe otherwise.

In the US, healthcare providers are required to report serious events and deaths, but there is no enforcement that I know of.

Providers don't want to report adverse events, because the lawyers that used to chase ambulances now hover over regulatory databases, looking for reports of patient injuries and deaths.

Providers are usually not regulated by the same agencies as those that regulate medical products, so the latter can't require the former to do much of anything. FDA is prohibited from meddling in the practice of medicine.

There is a difference between device safety and patient safety, although you would never know it from the rhetoric. Device safety is the responsibility of the device manufacturer, but it can't be achieved with postmarket surveillance. Patient safety is the responsibility of the patient's physician. "At its base, the FD&C Act is a law about labeling." The only meaningful responsibility of the regulators is to assure accurate labeling, but you wouldn't know it from the rhetoric.
 
W

Wolf.K

Quite Involved in Discussions
Here my old MDD PMS stuff; this is not MDR updated yet!

PMS plan for product X

A. Purpose
B. Scope
C. Responsibilities and authorities
D. Post market surveillance inputs, responsible person, frequency of review (depends on your products, e.g.:)
1. Table: products on the market comparable with product X
2. Important peer-reviewed publications
3. Competitive product IFU change analysis
4. Trade shows and conferences
5. Field evaluations and market surveys
6. PMCF
7. Scientific studies of competitive products
8. Competent authorities database search (FDA MAUDE, BfArM, TGA, soon hopefully EUDAMED)
9. New and revised regulatory requirements and external standards
10. Sales people trainings
11. Customer complaints
12. Customer inputs (not complaints)
13. Service and installation
14. Bug fixes
15. Customer surveys
16. Risk management file

E. Data summary
F. Discussion of data
G. Conclusions
H. Training of personnel

I. Approvals: (everybody involved has to sign, so nobody can say "I did not know that...")
1. PMS Plan approved by: (management)
2. PMS input preparation: Names, signatures
3. Responsible for preparation of PMS report: Name, signature

PMS report for product X:

Device Family:
Year:
Date prepared:
PMS report team and area: (table from D. above with)
TOC:
Product description
Products on the market comparable with X
Literature reviewed
PUMBED search
Important (peer-reviewed publications)
Conclusion literature review
Ifu analysis
Trade shows and conferences
Field evaluations and market surveys
Scientific studies conducted on product X
Summary scientific studies
Database search results for adverse event reporting of other products
Conclusions database search (-> direct input to risk assessment)
New and revised regulatory requirements (-> direct input to annual document review)
Summary and conclusions: Sales people trainings, customer complaints, customer inputs, services and installations, bug fixes, customer surveys,
Risk managment file - updated?
Overall summary of PMS data
Overall summary on post market analysis
Appendix (list of publications, IFUs, database findings and so on)
 
W

Wiola

Registered
Wolf.K said:
Here my old MDD PMS stuff; this is not MDR updated yet!

PMS plan for product X

A. Purpose
B. Scope
C. Responsibilities and authorities
D. Post market surveillance inputs, responsible person, frequency of review (depends on your products, e.g.:)
1. Table: products on the market comparable with product X
2. Important peer-reviewed publications
3. Competitive product IFU change analysis
4. Trade shows and conferences
5. Field evaluations and market surveys
6. PMCF
7. Scientific studies of competitive products
8. Competent authorities database search (FDA MAUDE, BfArM, TGA, soon hopefully EUDAMED)
9. New and revised regulatory requirements and external standards
10. Sales people trainings
11. Customer complaints
12. Customer inputs (not complaints)
13. Service and installation
14. Bug fixes
15. Customer surveys
16. Risk management file

E. Data summary
F. Discussion of data
G. Conclusions
H. Training of personnel

I. Approvals: (everybody involved has to sign, so nobody can say "I did not know that...")
1. PMS Plan approved by: (management)
2. PMS input preparation: Names, signatures
3. Responsible for preparation of PMS report: Name, signature

PMS report for product X:

Device Family:
Year:
Date prepared:
PMS report team and area: (table from D. above with)
TOC:
Product description
Products on the market comparable with X
Literature reviewed
PUMBED search
Important (peer-reviewed publications)
Conclusion literature review
Ifu analysis
Trade shows and conferences
Field evaluations and market surveys
Scientific studies conducted on product X
Summary scientific studies
Database search results for adverse event reporting of other products
Conclusions database search (-> direct input to risk assessment)
New and revised regulatory requirements (-> direct input to annual document review)
Summary and conclusions: Sales people trainings, customer complaints, customer inputs, services and installations, bug fixes, customer surveys,
Risk managment file - updated?
Overall summary of PMS data
Overall summary on post market analysis
Appendix (list of publications, IFUs, database findings and so on)
Click to expand...



Thank you ! :)
 
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