Expected lifetime of the device-Article 18

kunal9218

Starting to get Involved
#1
Hi,
According to MDR Article 18 Text – Clause 1 – Manufacturers
The manufacturer of an implantable device SHALL provide together with the device the following:
Any information about the expected lifetime of the device and any necessary follow-up;


Can someone please help me with this? Should this information be on the implant card or IFU? And what exactly is expected lifetime of a device? is it the expiry date or shelf life?
If it goes in Implant card or IFU, how do I address the requirement.


Thanks in advance.
 
Elsmar Forum Sponsor

RA_QA_Expert

Starting to get Involved
#2
Hi,

MDCG issued guidance MDCG 2019-8 v2 - Guidance document - Implant Card relating to the application of Article 18 Regulation (EU) 2017/745
Link: DocsRoom - European Commission Based on this guidance, lifetime is not included in the implant card.
So you should have this information in the instruction for use or on packaging

IMDRF Guidance Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices defines Expected Lifetime/Expected Service Life: Time period specified by the manufacturer during which the medical device or IVD medical device is expected to maintain safe and effective use.
NOTE 1: The expected lifetime can be determined by stability.
NOTE 2: Maintenance, repairs, or upgrades (e.g. safety or cybersecurity modifications) can be necessary during the expected lifetime.
 

dgrainger

Trusted Information Resource
#4
I would suggest that it is provided in a separate patient information leaflet.
That's my interpretation of Article 18 and Annex I 23.4 aa.

MDCG sadly only covers the additional implant card.
 
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