A CASE STUDY ON EU REGULATORY SUBMISSION OF CLASS III DRUG DEVICE COMBINATION PRODUCT (IUD)
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Asha Meria Johnson
Sr. Consultant
(EU Medical Devices Regulation)
I3CGLOBAL
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Introduction
“A satisfied customer is the best business strategy of all” – Michael LeBeouf.
The case study presented focusses on how meticulously I3CGLOBAL team supported one of its valued customers in obtaining the CE marking for two of their Intrauterine Devices (IUD).
This case study will cover the challenges we faced, approach/solution we provided, and the outcome we received, during the tenure of this project.
In this case study, we would like to take you through the regulatory submission process done by I3CGLOBAL for:
a) Copper T380A
Copper T380A consists of T shaped body, made from polyethylene compounded with barium sulphate, which bears a coil of copper wire (99.99 % pure) on its vertical arm, two Copper sleeves (99.99% pure) one on each of the horizontal arms and two monofilament HDPE threads tied with the bottom of the vertical arm. These four components make the device remain in the uterus until removed.
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b) CU 375 & CU 375 SL
Cu 375 and Cu 375 SL consists of an Inverted ‘U’ shaped body, made from polyethylene compounded with barium sulphate, which bears a coil of copper wire (99.99 % pure) on its vertical arm and two monofilament nylon threads tied to the bottom of the vertical arm. It is recommended for women with smaller uterus.
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KIND ATTENTION
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THE CHALLENGES
Copper T380A technical documentation upon review by the notified body had few non-conformities related to its risk analysis and PMCF.
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THE CHALLENGES
One of the major concerns was related to the Blue Nylon Monofilament (Polyamide 6,6) thread used on CU 375 & CU 375 SL. The manufacturer had used nylon thread suitable for use in non-implantable medical devices. The notified body had identified this issue during the technical review and kept on raising this issue as one of the major non-conformities despite of providing evidence such as the results of PMCF study and Biocompatibility studies
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OUR APPROACH
The eCTD project for IUDs was handled by 3 expert consultants at-a-time at the initial stage and, later as the notified body reviews began, it was taken care off by only 2 eminent consultants.
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OUR APPROACH
The issues existed in Copper T380A documentation were resolved through constant communication with the notified body.
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OUR APPROACH
Regarding CU 375 & CU 375SL, we requested the manufacturer to change the Nylon thread supplier and, informed the notified body that the manufacturer is ready to share the requested documents to them directly for review from the new Nylon thread supplier. We also informed them that the manufacturer is committed to perform the implantation test for the nylon thread in the finished device, to give complete assurance about the safety of the device.
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OUTCOME
Even though, there were serious challenges in front of I3CGLOBAL and the manufacturer, soon after the technical review by the notified body, the manufacturer received EC certificate for Copper T380A in Feb 2021.
However, the notified body agreed to issue the EC certificate for CU 375 & CU 375SL on conditional basis after supplying them with the chemical analysis to identify the purity of polymer, heavy metals, residues in the nylon suture supplied by the new nylon thread supplier, which is due by Sep 2021.
THANK YOU!
More Information: enquiry@i3cglobal.com
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