Emeritus Professor of Ophthalmology
University of Valladolid, Valladolid, Spain
It is obvious that the new regulation, Regulation (EU) 2017/745 named Medical Device Regulation or simply MDR (1) of the European Commission, represents a serious problem for many companies manufacturing medical devices that will have to adapt their productive systems, and especially their safety control, monitoring follow-up and notification of possible adverse effects in a very different manner.
The MDR is going to involve a series of very important changes, with the ultimate goal of ensuring that when a product with the CE marking is used, patients and doctors can have sufficient guarantees that the product is safe.
I do not know what has happened in other fields of medicine, but in the specific aspect of medical devices used in intraocular surgery, the behavior of many companies in recent years has been a complete scandal, producing hundreds, probably thousands of blind people worldwide and creating a terrible feeling of insecurity into the eye surgeons.
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