ISO/TC 84 Meeting regarding Needle-Based Injection Systems
ISO/TC 84 is currently meeting in Milpitas (CA) to discussing updates to current standards related to needle-based injection systems (e.g. ISO 11608-1, -4, and -5) and an upcoming standard (ISO 11608-6 regarding “on-body delivery systems”). Beat U. Steffen and Charles Cathlin from #confinis enjoy lots of fruitful discussions and hard work with leading experts in the field – great spirit and progress!
Thanks a lot to Flex for being perfect hosts!
#combinationproducts #medicaldevices #confinis #flex
Classification of medical devices under the European Medical Device Regulation 2017/745 - by Joachim Makowski
Get his outline about classification of medical devices under #MDR and direct comparison of #MDR and MDD classification rules: https://lnkd.in/dxVmhQm
A new version of the borderline manual for #medicaldevices was published (version 1.20 (10-2018)).
New products covered are:
- Mattress covers against mites (1.25)
- Lubricants intended for body massages and/or sexual intercourse (1.26)
- Trial hip prosthesis heads or stems (8.31)
- Product intended to facilitate conception based on basal body temperature (9.9)
- Product intended to facilitate conception and enable contraception based on basal body temperature (9.10)
- Standalone software applications for conception and contraception purposes using data entered by the patient (9.11)
Please note that the manual relates to the MDD and the IVDD and not the #EUMDR and #IVDR.
Whenever we intend to invest in a company that plans to sell medical devices or combination products we involve confinis in our due diligence process to assess the regulatory strategy, verify compliance with applicable regulations and challenge the time required to obtain marketing authorization. confinis’ expertise regarding EU and US requirements in this area is simply unrivaled and their dynamic and entrepreneurial team are a pleasure to work with.
Patrick M. Aisher
Chairman, Kinled Holding Ltd.
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