Together. All the way.

Introduction to Medical Device Regulations - MDR

For 30 years medical devices have been governed by the Medical Device Directive (MDD) implemented in EU/EEA in 1993, and there have been quite a few developments in the field of medical devices since then. For instance, apps used as stand-alone products for different medical purposes have become a reality. The general population has become older, patients are more used to finding medical information on the internet, and the beauty industry uses more advanced and invasive techniques than before. These changes, and more, have prompted an update of the control of medical devices for some time. Eventually, the new Medical Device Regulations (MDR) were developed and came into force on May 26, 2021. From this date, all new medical devices and the manufacturer’s quality management system must comply with the MDR. Implementation deadlines for existing devices are dependent on classification and expiry of existing MDD certificates.

“A picture is worth a thousand words” – this old proverb is embraced and applied by medical device manufacturers all around the world, but why is that?
The answer to that question starts with the fact that most countries’ health authorities require medical device manufacturers to provide product information to the users in their local language. This is a not a problem for manufacturers who produce and distribute big volume products where an entire batch will be sold in only one country. They simply produce batches dedicated to the specific country with product information in that local language.

Vitrolife was the first company to have all its IVF products CE marked. So you can be sure our products fulfil the toughest demands on health and safety. Our core values are quality, safety and efficacy – and we invest a great deal of time and effort in meeting regulatory demands.

Quality is the #1 value at Vitrolife and is totally integrated in the organisation. The company was founded on the idea that high and consistent product quality improves the take-home baby rates for our customers.