The Medical Device Regulation and its Impact on Lens ... | 合法醫療器材資訊網
By Steven Morgan
With the release of the Medical Device Regulation (EU 2017/745) in May of this year, the European Parliament has significantly strengthened the regulatory requirements on manufacturers of CE marked medical devices. In light of this review, I felt it would be useful to explore some of the practical challenges facing medical device manufacturers.
The differences between the current Medical Device Directive (MDD) and the Medical Device Regulation (MDR) are significant and in most cases manufacturers will need to plan carefully so as to complete the additional work necessary in the required timescales.
TimescalesMay 2017 with a three-year transition period before replacing the MDD. During this transition period, any product certificates issued by the Notified Bodies (NB’s) will be valid for a maximum of four years after the end of the transition peri...
MDR | 合法醫療器材資訊網
Intraocular lens manufacturers | 合法醫療器材資訊網
DGR | 合法醫療器材資訊網
The Medical Device Regulation and its Impact on Lens ... | 合法醫療器材資訊網
MDR brand of Intraocular Lenses | Medical | 合法醫療器材資訊網
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