OPHTEC receives CE certificates while European medical device regulations are at risk of running aground22-11-2022
Groningen, November 2022 – OPHTEC, a producer of intraocular lenses (IOLs) in Groningen, has had four CE markings for its products renewed. This achievement is even more exceptional at a time when the introduction of the new European medical device regulations (MDR) is at risk of running aground.
OPHTEC has received the CE markings for its whole portfolio of PRECIZON lenses. These are better known as the artificial lenses that patients receive as implants in cataract operations. The strengthened European medical device regulations (MDR) place stricter safety and quality requirements on manufacturers, importers and distributors.
“We are particularly proud to be one of the first organisations in our sector to receive this approval”, says Erik Jan Worst, OPHTEC CEO. “Quality and patient safety have always been our main priority. As a relatively small player from Groningen operating in a global market, we see the fact that we are able to meet these strict requirements as a reward for our work. And at a time when it is extremely difficult to get products approved.”
Erik Jan Worst wants to say more about this difficult approval process. “Medical device manufacturers are under great pressure to comply with the new MDR. The introduction of these regulations places a great administrative burden on organisations, while regulatory bodies can barely cope with the stream of paperwork. The new regulations seem to be good for patients, but in practice have a paralysing effect on suppliers in the medical industry and therefore on innovation and the availability of devices, some of which are even life-saving.”
Erik Jan Worst looks to the future with confidence. Together with 300 companies, OPHTEC is an advocate for change in Brussels. “We want to monitor the situation in the USA with the FDA; where they are reducing the regulatory burden again because the power is shifting too much towards larger companies, and there is little room for healthy competition and innovation. Our products have proven their quality on the market for the last 40 years. We are well known as an extremely reliable partner for ophthalmologists. In the coming years we will be launching a number of promising new products, which we will ensure are approved as well”.Previous page