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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.

The unique design of SENSE™ provides ideal conditions for optimised oocyte retrieval performance and aspiration time as well as improved patient comfort. Prof William Ledger is Head of Obstetrics & Gynaecology at the University of New South Wales and Director of Reproductive Medicine at The Royal Hospital for Women, Sydney. In this video, Prof Ledger shares his expertise, experience and why he has chosen to use SENSE™ follicle aspiration for all his patients.

Controlling pH in embryo culture media is often perceived as difficult by embryologists. Still, to maintain the optimal physiological pH range of 7.20 – 7.40 is essential to maintain oocyte and embryo viability. Many functions in embryo cells such as glycolysis, protein metabolism, cytoskeletal dynamics​, cell transport and epigenetic functions are all dependent on pH.

This is an abbreviation of Jason Swain (2019) publication with emphasis on the oil used for medium overlay written by Ann-Helene Jakobsson, Vitrolife. 

Perfect oil for IVF should do nothing but protect the culture. It should not have any negative influence on the gametes, embryos or media by adding unwanted or removing necessary components. However not all oils are or act the same. In this blog post I will guide you through different types of oil and things to consider when choosing oil for your IVF culture.

This blog focuses on EmbryoGlue^® as there are now three Cochrane reviews showing improved clinical outcome when using this transfer medium, which contains a functional concentration of hyaluronan. The Number Needed to Treat (number of patients treated with EmbryoGlue to achieve an additional live birth) is reported to be around 17 patients, so perhaps the use of this specifically created transfer medium should not be considered an add-on, but rather a standard of care.

This year, online was the place to be when participating in the 76^th annual meeting of ASRM. In this blog post, thoughts and reflections from the Vitrolife team have been collected on some of the scientific content presented at the meeting.

What has lactate (aka lactic acid) got to do with embryos? Most people are familiar with this carboxylic acid only in the context of it as the end product of glucose use through glycolysis that builds up in your muscles when you exercise at the gym! Well, it transpires that lactate is actually a key regulator of embryo function, with new roles emerging as our understanding of cell physiology increases. In other words, it is far more important than we originally thought.

The 36th annual meeting of ESHRE took place online this year, with more than 12,000 registered participants. Like last year, the Vitrolife team has put together our thoughts and reflections on some of the scientific content from the meeting. We also offer the opportunity to watch our recorded scientific symposium again.

What is artificial intelligence?

Artificial intelligence is widely used and affects our daily lives even if we do not notice. From smart phone tools and personalised shopping experiences to assisted airline operations and medical diagnosis. When the appropriate method is chosen and trained on data that sufficiently represents the intended use, artificial intelligence makes our life easier and more comfortable.