Contamac QM Manager Steve Morgan: The Medical Device Regulation and its Impact on Lens Manufacturers
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…