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    Achieving and Maintaining Regulatory Compliance is our speciality.

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    Tailored Solutions
    for your Regulatory

Currently, there are three directives regulating medical devices in Europe. Most medical devices in the EU are regulated by and must comply with, the Medical Device Directive MDD 93/42/EEC as amended by Directive 2007/47/EC which came into force in March 2010.

Other groups of medical devices are regulated by specific directives. This is the case of in-vitro diagnostic medical devices which are regulated by and must comply with, Directive 98/79/EC; and active implantable medical devices which are regulated by and must comply with, Directive 90/385/EEC, also last updated by Directive 2007/47/EC.

In 2017, two (2) new Regulations on medical devices were approved and came into force on May 25, 2017. These new regulations will change drastically the requirements applying to medical devices in Europe and the approach to CE-marking. These new regulations will apply to all medical devices in 2020 and to all in vitro diagnostic medical devices in 2022. Our advice is to take the new requirements already into account, when possible.

The approach of BioTop Medical is to develop for its clients, a tailored regulatory strategy which should lead to product regulatory compliance and CE marking of the device. The strategy may involve for example, the assessment of the company quality system, the assessment of product classification, identification of applicable essential requirements, selection of the applicable standards, evaluation of the product design documentation and the selection of the Notified Body. Finally, BioTop Medical will prepare the device Technical Documentation.

A critical aspect of the whole process is good communication. BioTop Medical has extensive experience in communication with the parties involved in the development and production of medical devices as well as with the Notified Body auditors. Clear-cut, simple and precise wording is used to ensure that the necessary details are shared in a practical and appropriate fashion preventing unwanted delays on the critical path to certification.