The need for the MDR (Medical Device Regulation)

J. Carlos Pastor MD, PhD

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.


1.- : last visit January 11/2022

2.- Lenzer J; ICIJ reporters. Medical device industry: international investigation exposes lax regulation. BMJ. 2018 Nov 25;363:k4997. doi: 10.1136/bmj.k4997. PMID: 30473543.

3.-  Pastor JC The Safety of Medical Devices Used During Intraocular Surgery. Ophthalmic Review. 2021;13(2):73–5 DOI:

4.- Cibis PA, Becker B, Okun E, Canaan S. The use of liquid silicone in retinal detachment surgery. Arch Ophthalmol. 1962 Nov;68:590-9. doi: 10.1001/archopht.1962.00960030594005. PMID: 14021325.

5.- Pastor JC, Del Nozal MJ, Marinero P, Díez O. [Cholesterol, alpha-tocopherol, and retinoid concentrations in silicone oil used as a vitreous substitute]. Arch Soc Esp Oftalmol. 2006 Jan;81(1):13-9. Spanish. doi: 10.4321/s0365-66912006000100005. PMID: 16450256.

6.- Valentín-Bravo FJ, García-Onrubia L, Andrés-Iglesias C, Valentín-Bravo E, Martín-Vallejo J, Pastor JC, Usategui-Martín R, Pastor-Idoate S. Complications associated with the use of silicone oil in vitreoretinal surgery: A systemic review and meta-analysis. Acta Ophthalmol. 2021 Nov 29. doi: 10.1111/aos.15055. Epub ahead of print. PMID: 34846097.

7.- Dresp JH. Benchmarking different brands of perfluorocarbon liquids. Graefes Arch Clin Exp Ophthalmol. 2021 Jan;259(1):21-27. doi: 10.1007/s00417-020-04964-6. Epub 2020 Nov 27. PMID: 33245429.

Article ID: A0301015    RA  Preprint
Received: 31/12/2021  
Accepted: 31/12/2021
Published: 31/12/2021

How to cite this paper