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  • Instructions for Use and Medical Devices

    Instructions for Use and Medical Devices

    CE marking on medical devices indicates that they comply with the applicable European legislation with regard to product safety. Part of the CE marking process is drafting the Instruction For Use (Hereafter: IFU). The IFU provides general information on the use…

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  • Does Private Labelling still exist?

    Does Private Labelling still exist?

    Does Private Labelling still exist? In the medical device world often already certified products are being bought by companies with the intention to bring them onto the European market under their own trade name. This is commonly known as bringing a product onto…

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  • CFDA Medical Device Certification China

    CFDA Medical Device Certification China

    For the CFDA Medical Device Certification the China Food and Drug Administration (CFDA) recently released the 2016 Annual Report for National Medical Device Adverse Event Monitoring, which includes the general situation of medical device adverse event reporting,…

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  • May 26th 2017, critical day for Medical Devices in Europe

    May 26th 2017, critical day for Medical Devices in Europe

    On May 5th 2017 the Official Journal of the European Union published the new Medical Devices Regulation (EU) 2017/45. According to the new Medical Devices Regulation the Regulation enters into force on May 26th 2017. The current legislation on medical devices, i.e. the Medical Devices Directive 93/42/EEC, will be repealed with effect from May 26th 2020. As such there will be a transitional period of three years for all parties concerned with medical devices to adjust their activities in order to comply with the new Medical Devices Regulation.

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