It is no surprise to anyone in the medical device industry that the transition from EU MDD to EU MDR has seen quite a few hiccups over the past couple of years. The most recent obstacle, however, comes in the form of delays from Notified Bodies. The scale of the bottleneck coming from Notified Body capacity to review EU MDR applications has not been a secret, but a recent industry poll sheds light on the growing concern.
A ‘CS’ was to be a ‘Common Specification,’ intended to satisfy the EU MDR requirements. If you were working to comply with the EU’s Regulation on in vitro Diagnostic Medical Devices ((EU) 2017/746)2, or EU IVDR, the equivalent to a CS was referred to as a ‘CTS’ (“Common Technical Specification”).
What makes teams successful, based upon a study of employees working within process improvement teams for each of six large corporations, led to a list of approaches for achieving organizational quality, albeit one improvement project at a time. When I parsed these lists together with a focus upon leadership to achieve organizational quality, I was able to place the key concepts into the seven categories listed below.
Coronavirus (COVID-19) has been prevalent in the United States for over 2 years, on July 6th, the Food and Drug Administration (FDA) modified the Emergency Use Authorization (EUA) for Paxlovid for COVID-19 treatment. Paxlovid is a co-packaged, nirmatrelvir tablet and ritonavir tablet for oral use to assist with the treatment of COVID-19 in adult and pediatric patients with positive SARS-CoV-2 testing1. The nirmatrelvir inhibits the SARS-Cov-2 protein to stop the virus whereas the ritonavir slows down the breakdown of nirmatrelvir to help it remain in the body for a longer period.
If you are a drug manufacturer in the US, an Annual Drug Product Review (ADPR) should be familiar to you. ADPRs are exactly what they sound like – an annual review of your drug product based on product batch and product yield, customer complaints, recalls, stability data, and validation data just to name a few. ADPRs should be performed in order to maintain compliance with 21 CFR 211.180 and to be in alignment with the FDA’s Guidance for Industry, Q7A GMP for Active Pharmaceutical Ingredients.[1]
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