REUSABLE SURGICAL INSTRUMENTS - VDI 5700
August 2017 - Under the Medical Device Regulation 2017/745 reusable surgical instruments of CE Class I will regulatory-wise be treated analogous to Class I devices with a measuring function or supplied sterile under the MDD already today: The Notified Body will specifically verify the technical documentation of the instrument in all aspects relating to its reuse (maintenance of safety and effectiveness, cleaning, disinfection and resterilization, functional life time, maintenance and repair, related instructions for use, etc., cf. MDR Art. 52.7(c)). During an audit of the manufacturer's quality management system these aspects could also be in focus.
Non-German speaking manufacturers might not be aware of the Association of German Engineers' publication VDI 5700, Reprocessing hazards - Risk management in reprocessing of medical devices, consisting of Part 1: Measures for risk control and Part 2: Trainings. The publication is bilingual German / English and can be used like a dictionary because the two languages are arranged in two columns. Tables of contents, also bilingual, are publicly available from Beuth Verlag - so decide yourself whether VDI 5700 is a useful investment for you.
RESPONSIBLE PERSON - MDR Article 15
April 2017 - The new European MDR, in its Article 15, requires manufacturers to nominate a person responsible for regulatory compliance with the requisite expertise in the field of medical devices .
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European enterprises which employ <50 persons and whose annual turnover and/or annual balance does not exceed EUR 10 million can outsource this function, provided the responsible person is permanently and continuously at their disposal.
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The decades of experience I can bring in to your project by far exceeds the MDR requirements. Specifically I can take regulatory responsibility for
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vascular intervention devices such as stents, balloon catheters and guide wires, including coronary and carotid
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bone fracture fixation devices such as bone screws and plates, IM nails, spinal implants
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bone replacement and fillers such as Calcium Phosphate materials
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orthopedic implants for hip, knee and shoulder joints
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dental implants
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related surgical instruments, labeling and instructions for use
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In the case of clinical studies, the responsible person issues the conformity statement for the investigational device.