SBS - The best value in QMS software

"Placing on the market" & "putting into service"- one time regulatory event or Continual supply event?

N

nz1nz2

Starting to get Involved
#1
#1
Dear Forum members,
It seems i have a different point of view for the three definitions which i'm having difficulty to explain to my colleauges. I would be delighthed to hear your thoughts on this topic.
The use of the word "first" both in the "placeing on the market" and "put into service" made me think on this two events as regulatory one-time events, i.e. happen once the first time a device is made available in the EU and not each time a batch/lot is made availabe. for example if a manufacturer first introduce a new medial device in the EU it is considered to place the product to the EU market (regulatory event). All other supplies of this product to the EU is considered to fall under "making the product availabe" (supply events). The only next time this manufacturer will "place" this device on the market again is if there's a significant change to the device which will make the company to "place" the device again to the market. This fits well with the reqquierment that no major change can be done to an already "place on the market" device in order for it to be "available on the market" during the transition period.

If i use the "make available" definition inside the "place on the market" definition it would be:
Placeing on the market: Any first supply of a device, for distribution, consumption or use on the union market in the course of commercial activity...

Thank you in advance for any comment.
 
Popular whitepapers from DISCUS
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
R SaMD - Placing on the Market before DoA EU Medical Device Regulations 2
N When is "placing on the market"? MDD certified medical devices EU Medical Device Regulations 32
D ROHS 2 - Medical Device: Placing vs Making Available on the market EU Medical Device Regulations 3
R RoHS and placing on the market in Non EU countries RoHS, REACH, ELV, IMDS and Restricted Substances 3
C Medical Device Marketing vs. Placing Product on the Market EU Medical Device Regulations 8
C What is "Placing on the Market" in EU? Brochures or Install? CE Marking (Conformité Européene) / CB Scheme 6
A Ownbranding or placing on market without CE mark ISO 13485:2016 - Medical Device Quality Management Systems 7
I Additional National requirements for placing MD in the EU countries EU Medical Device Regulations 7
Y CE Mark - Placing the CE mark on medical device labels EU Medical Device Regulations 2
J Facilities - Placing our assembly group into a separate building ISO 13485:2016 - Medical Device Quality Management Systems 8
G Placing a dollar value on our QMS (we are looking at IP protection) Quality Manager and Management Related Issues 3
C Reducing paperwork and placing in Systems electronically - Electronic documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Automated Processing and Placing Parts Manufacturing and Related Processes 4
J How can I evaluate a new supplier prior to placing an order? Supplier Quality Assurance and other Supplier Issues 7
P Clinical Trial Requirement - No equivalent devices in the market CE Marking (Conformité Européene) / CB Scheme 3
D Economic Operators, EU Market Access EU Medical Device Regulations 2
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 1
D Deciding whether or not pre-market clinical investigation is required for low risk device EU Medical Device Regulations 5
R Information on obtaining a market authorization for China China Medical Device Regulations 2
M EU MDR - Labilities when a device is discontinued from the Market EU Medical Device Regulations 1
A Packaging device with accessories already on the market Other Medical Device Regulations World-Wide 0
S Can a Contract Manufacturer "release" product on behalf of client to the market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
dgrainger Clue to UK's new regulatory requirements - approval of all devices placed on the market? Other Medical Device Regulations World-Wide 1
F When to market and distribute device in EU? EU Medical Device Regulations 3
N Post Market Surveillance Package Example Wanted ISO 13485:2016 - Medical Device Quality Management Systems 1
T Modification of a product on the market EU Medical Device Regulations 2
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 Post Market Surveillance for Class II Medical Devices Medical Device and FDA Regulations and Standards News 2
H Post-market surveillance strategy EU Medical Device Regulations 1
B Procedures for Complaint Handling and Post Market Surveillance EU Medical Device Regulations 7
A Post-market clinical followup studies (PMCF) EU Medical Device Regulations 16
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
K EU MDD Class I Device market access / certification after 26th May 2020 EU Medical Device Regulations 9
T Post-Market Surveillance Plan - Requirements outlined in Annex III (1.1b) EU Medical Device Regulations 2
M Informational Health Canada guidance document – Pre-market Requirements for Medical Device Cybersecurity Medical Device and FDA Regulations and Standards News 0
Y Post Market Surveillance Indicators and Analysis method EU Medical Device Regulations 1
M Post Market Surveillance Plan Template EU Medical Device Regulations 10
F Vietnamese Post-Market Surveillance Requirements for a medical device in Japan Other Medical Device Regulations World-Wide 0
M PMCF (Post Market Clinical Followup)/ PSUR template EU Medical Device Regulations 8
C Shipping Medical Devices to US before pre market clearance US Food and Drug Administration (FDA) 1
M New medical device on the market before MDR EU Medical Device Regulations 12
M Informational The ANSM decides, as a precautionary measure, to withdraw from the market macrotextured breast implants and breast implants with polyurethane-coated s Medical Device and FDA Regulations and Standards News 0
S PMCF (Post Market Clinical Followup): Rationale for Exemption - Software Medical Devices EU Medical Device Regulations 6
M Informational MDCG 2019-3 Interpretation of Article 54(2)b – Pre- market clinical evaluation consultation procedure with the involvement of expert panels Medical Device and FDA Regulations and Standards News 0
S Post Market Surveillance and Annual Product Review in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2
M Informational TGA – Q&A: Use of market authorisation evidence from comparable overseas regulatory bodies for medical devices Medical Device and FDA Regulations and Standards News 0
K Post Market Clinical Follow up and CE Marking for Class IIb medical X-Ray products CE Marking (Conformité Européene) / CB Scheme 1
M Informational Links to recognized / harmonised / consensus Standards for each market Other Medical Device Related Standards 5

Similar threads

Top Bottom