Most Read Medical Device Articles of 2019
2019 has been a busy year for people involved in the medical devices sector. The imminent arrival of MDR, on May 26th next year, is concentrating the minds of those within the industry. It has been a busy year also for our medial devices team. Nevertheless, they have had time to look at the big issues in the sector and write about them for the Acorn Regulatory website.
Update: You will see that some of our comprehensive MDR content that we have created refers to the May 2020 date of application. The date of MDR application has moved to May 26th, 2021. Articles that were written prior to the delay referenced the earlier date. However, articles that you might read that reference the earlier date should be read taking the new date of May 2021 into consideration. Read more here.
Here are some of the most widely read articles that the wrote in the past year.
The decisions by Lloyd’s Register Quality Assurance (the LRQA) and QS Zurich that they will both will cease to offer notified body services under the EU’s existing medical device and in vitro diagnostic directives and that they will not seek to become a notified body under the new medical device regulations has been met with some dismay by manufacturers. You can read more about how this issue caused many issues for concerned companies, here.
As part of our series of articles looking at some of the changes on the way for medical device regulation under MDR, we are looking at the role of the Person Responsible for Regulatory Compliance (PRRC). The role of QP is a familiar one for those working in the Pharma sector, but this is the first time in European medical devices legislation that a person is required to be appointed by a manufacturer to take specific responsibility for regulatory compliance of devices. Read more about it here.
The new medical device regulations (MDR) will come into force in May 2020. In advance of the deadline, companies across the world are working to ensure that their devices will comply with the new regulations. For many companies there is still much work to do. Also, companies are still actively seeking further information about the regulations and how they will be applied. Download the whitepaper, here.
Change is the only constant in the life sciences sector and the introduction of the new medical device regulations in May 2020 will bring significant changes to the way that we work with medical devices. We have been working with many companies to support them for the changeover from the MDD to MDR. During the course of our interactions with these clients there are many topics that are being raised time and again. Read the full article here.
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